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Review Article
9 (
1
); 9-20
doi:
10.25259/JCCC_49_2024

Blood Clot Consensus Recommendations on Bleeding Management during Cardiac Surgery in Low-Resource Settings using E-Delphi Methodology

Department of Cardiac Anaesthesia and Critical Care, Cardiothoracic and Neurosciences Centre, All India Institute of Medical Sciences, New Delhi, India
Department of Cardiac Anaesthesia and Critical care, Narayana Institute of Cardiac Sciences, Bengaluru, Karnataka, India
Department of Cardiac Anesthesiologist and Intensivist, EPIC Hospital, Ahmedabad, Gujarat, India
Department of Cardiac Anaesthesia, MGM Healthcare, Chennai, Tamil Nadu, India
Department of Transfusion Medicine, Jubilee Mission Medical College and Research, Thrissur, Kerala, India
Department of Pediatric Cardiac Anaesthesia and Intensive Care, Children Heart Center, Kokilaben Ambani Hospital and Research Center, Mumbai, Maharashtra, India
Department of Cardiac Anaesthesia, Madras Medical Mission, Chennai, Tamil Nadu, India
Department of Cardiac Anaesthesia and Critical Care, Desun Hospital and Heart Institute, Kolkata, West Bengal, India
Department of Critical Care and Anaesthesiology, Medanta - The Medicity, Gurugram, Haryana, India.

*Corresponding author: Poonam Malhotra Kapoor, Department of Cardiac Anaesthesia and Critical Care, Cardiothoracic and Neurosciences Centre, All India Institute of Medical Sciences, New Delhi, India. drpoonamaiims@gmail.com

Licence
This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-Share Alike 4.0 License, which allows others to remix, transform, and build upon the work non-commercially, as long as the author is credited and the new creations are licensed under the identical terms.

How to cite this article: Kapoor PM, Kanchi M, Shastri N, Genny SK, Jacob SI, Tailor KB, et al. Blood Clot Consensus Recommendations on Bleeding Management during Cardiac Surgery in Low-Resource Settings using E-Delphi Methodology. J Card Crit Care TSS. 2025;9:9-20. doi: 10.25259/JCCC_49_2024

Abstract

India conducts around 240,000 adult cardiac surgeries annually, with bleeding and transfusions being common complications that can worsen outcomes. Implementing patient blood management strategies can reduce unnecessary transfusions and improve results. With emerging management options and point-of-care testing, the need for standardized bleeding management during cardiac surgery in India became evident. The Blood Clot (Indian Bleeding Management during Cardiac Surgery) Working Group convened 3 times (one in-person, two virtual) to discuss and vote on consensus-based recommendation statements derived from a Delphi process. The online Delphi platform enabled anonymous voting, providing real-time statistical insights during discussions. Using the accurate consensus reporting document methodology, 26 recommendations were finalized, covering pre-, intra-, and post-operative bleeding management. The recommendations included both Thrombelastography (TEG)/Rotational thromboelastometry (ROTEM) and non-TEG/ROTEM-based algorithms, along with specific guidance for managing bleeding in cyanotic congenital heart disease surgery. These consensus-based recommendations represent the first comprehensive, India-specific guidelines for managing bleeding during cardiac surgery, aiming to optimize practices and potentially set a new standard of care. This approach could also influence global practices in similar contexts.

Keywords

Bleeding
Cardiac surgery
Point-of-care testing
Patient blood management
Indian recommendations
Delphi

INTRODUCTION

Every year in India, around 240,000 adult cardiac surgeries, including valve surgeries and coronary artery bypass grafting, are performed in approximately 420 centers.[1]

Bleeding, a significant complication, affects 2–15% of cardiovascular surgeries, leading to high morbidity.[2-5] Causes include platelet dysfunction, clotting factor dilution, hypothermia, and fibrinolysis. Severe bleeding can necessitate re-exploration in 3–14% of cases, with 50–67% of these revealing a surgically correctable source.[6-10] Bleeding and surgical re-exploration are both independent predictors of an adverse outcome in cardiac surgery.[11]

Comprehensive bleeding assessment during surgery is challenging due to the dynamic coagulation cascade.[12,13] A multimodal approach, supported by institutional protocols and point-of-care testing, is vital, especially in India with limited resources. The Indian Bleeding Management during Cardiac Surgery (Blood Clot) Working Group developed 26 recommendation statements based on expert consensus to guide clinical practice. These recommendations, derived from a Delphi process, aim to provide the best treatment paradigm for bleeding management in cardiac surgery, considering local context and practical experiences. Regular reassessment of these recommendations is advised to incorporate new evidence and technologies.

METHODOLOGY

The study protocol was not prospectively registered. Led by Prof. Yatin Mehta and Prof. Poonam Malhotra, the Delphi method leveraged the expertise of nine cardiac anesthesiologists selected for their extensive experience in managing bleeding during cardiac surgery. This need for clinical guidelines specific to India was recognized during an advisory board meeting in June 2023 in New Delhi, covering various adult and pediatric cardiac surgeries. A literature review informed the initial thematic statements, focusing on bleeding management techniques, patient outcomes, blood management strategies, and advances in monitoring and intervention methods. The review included databases such as PubMed, Cochrane Library, Scopus, Web of Science, and Google Scholar from January 2016 to February 2023.

The E-Delphi platform was used for the survey, without a pilot study. Key clinical questions were reviewed by experts, resulting in 26 thematic statements. These statements were discussed in three meetings (one in-person, two virtual), moderated by Prof. Malhotra, with live changes made by a medical writer. Consensus was defined as ≥80% agreement, with statements excluded if they did not achieve a minimum of 50% consensus. All statements reached the consensus threshold in the first round, with results visible in real-time on the E- Delphi portal.

Two initial recommendations were omitted as they represented general practice. Feedback was provided after each meeting, with anonymized votes visible at all times. Participants were reimbursed only for the first meeting. Descriptive statistical analysis was conducted to summarize responses. Ethics Committee approval was not required as the study did not involve patient-specific therapies or data. The methodology adhered to accurate consensus reporting document (ACCORD) guidelines[14] and good data protection practices.

RESULTS

A total of 26 statement recommendations (R1 to R26) were developed. The statements were divided into “General recommendations,” “Pre-operative,” “Intra-operative,” and “Post-operative” recommendations, as follows:

General recommendations

R1. Transfusion practices during cardiac surgery must be “restrictive,” rather than “liberal,” and supported by measures like:

  1. Intensifying treatment of anemia in the pre-operative period,

  2. Use of minimally invasive surgical techniques,

  3. Use of standardized protocols guiding the use of blood components and

  4. Minimizing intra- and post-operative iatrogenic blood loss (77.78% Strongly agree; 22.22% Agree; Standard deviation [SD] = 0.416).

R2. The management options for non-surgical bleeding during cardiac surgery include the use of packed red blood cells (PRBC), cryoprecipitate, platelet concentrate (random donor/single donor), fresh frozen plasma (FFP), fibrinogen concentrate, prothrombin complex concentrate (PCC), and recombinant factor VIIa (87.5% Strongly agree; 12.5% Agree; SD = 0.331).

R3. Drugs such as antifibrinolytics, for example, tranexamic acid, epsilon aminocaproic acid (EACA), and desmopressin may be added in cases of continued bleeding. Protamine dose is about 70% of the primary heparin dose and more than 1005 should strictly be avoided. Antidotes for direct thrombin inhibitors, hemadsorption therapy for Novel Oral Anticoagulants, and their antidotes should be added depending on the individual anticoagulants used (75% Strongly agree; 25% Agree; SD = 0.433).

R4. The recommended point-of-care/viscoelastic tests in a bleeding patient to diagnose/treat/monitor transfusion during cardiac surgery are activated clotting time (ACT), hematocrit, extrinsic thromboelastometry (EXTEM), fibrinogen thromboelastometry (FIBTEM), intrinsic thromboelastometry (INTEM) and heparin thromboelastometry (HEPTEM), Kaolin thrombelastography (TEG), heparinase TEG, rapid TEG and TEG Functional Fibrinogen/Multiplate/Rotational thromboelastometry (ROTEM) platelet/Verify now/TEG platelet mapping and QUANTRA, whichever is available in the institution of a POC testing device (87.5% Strongly agree; 12.5% Agree; SD = 0.331).

Pre-operative recommendations

R5. A pre-operative multidisciplinary team (cardiac anesthesiologists, cardiac surgeon, intensive care unit [ICU] physician, transfusion medicine specialist, clinical pharmacist, perfusionist, and hematologist) to discuss aspects such as invasive monitoring, cannulation sites, management of cardiopulmonary bypass (CPB), post-bypass inotropic support, chest closure, ventilatory support, and blood conservation management planning is encouraged for best alignment (87.5% Strongly agree; 12.5% Agree; SD = 0.331).

R6. Pre-operatively patients requiring and/or are at high probability of transfusion (advanced age, complex re-do surgery) can be identified by checking for iron deficiency anemia, non-iron deficiency anemia, platelet count, and fibrinogen level. Platelet function testing should additionally be done in patients taking purinergic receptor type Y, subtype 12 inhibitors or dual anti-platelet therapy (77.78% Strongly agree; 22.22% Agree; SD = 0.416).

R7. In patients who have pre-operative anemia, or in those who refuse a blood transfusion, it is recommended to administer pre-operative oral iron therapy or erythropoietin-stimulating agents along with oral iron supplementation several days before cardiac surgery to increase red cell mass (88.89% Strongly agree; 11.11% Agree; SD = 0.314).

R8. In patients undergoing elective cardiac surgery, anti-platelet medications such as ticagrelor should be withdrawn preoperatively for a minimum of 3 days, clopidogrel for 5 days, and prasugrel for 7 days, and stop all group IIb/IIIa inhibitors for 4–6 h before surgery. It is reasonable to continue low-dose aspirin therapy until the time of surgery. In patients undergoing emergency cardiac surgery on P2Y12 inhibitors or direct factor Xa inhibitors such as apixaban or rivaroxaban with high bleeding risk, consider hemadsorption (87.5% Strongly agree; 12.5% Agree; SD = 0.331).

R9. For patients on pre-operative warfarin, it should be stopped 3–5 days before surgery, and other non-Vitamin K-dependent oral anticoagulants should be stopped 48 h before surgery and bridged with heparin (87.5% Strongly agree; 12.5% Agree; SD = 0.331).

Intraoperative recommendations

R10. Intraoperative autologous blood donation in adult patients with hemoglobin levels (>13 g/dL) may be considered to reduce post-operative transfusions (88.89% Strongly agree; 11.11% Agree; SD = 0.314).

R11. Intraoperatively, hemostasis should be maintained, and blood loss should be reduced by minimizing hemodilution, maintaining individual heparin and protamine titration, maintaining normothermia and normal pH and preventing fibrinolysis (88.89% Strongly agree; 11.11% Agree; SD = 0.331).

R12. A baseline ACT is estimated. The ACT is maintained at more than 480 s on cardiopulmonary bypass after an intravenous administration of unfractionated heparin (UFH) of 300–400 IU/kg. For off-pump surgery, UFH of 100–200 U/kg with a target ACT of 250–300 s is recommended (77.78% Strongly agree; 22.22% Agree; SD = 0.416).

R13. Intraoperatively, during CPB, the factor reaching critical levels earliest is fibrinogen, which leads to bleeding. Cryoprecipitate and/or fibrinogen concentrates can be supplemented in the post-bypass period to correct hypofibrinogenemia (87.5% Strongly agree; 12.5% Agree; SD = 0.331).

R14. Standardized hemostatic algorithms that incorporate point-of-care testing, such as with viscoelastic devices and with pre-defined intervention triggers should always be preferred to diagnose/treat/monitor transfusion practices during cardiac surgery over anesthesiologists’/cardiac surgeons’ clinical discretion and conventional coagulation assays (25% Strongly agree; 75% Agree; SD = 0.433).

R15. Pre-emptive steps should be taken by a cardiac anesthesiologist (CA) intraoperatively on an individualized patient basis, as shown in Flowchart 1 (44.44% Strongly agree; 44.44% Agree; SD = 1.197).

Intraoperative pre-emptive steps to be taken by cardiac anesthesiologist on an individualized patient basis. OT: Operation Theatre.
Flowchart 1:
Intraoperative pre-emptive steps to be taken by cardiac anesthesiologist on an individualized patient basis. OT: Operation Theatre.

R16. Physiological transfusion triggers: Multiple studies have proven that a restrictive blood transfusion strategy is non-inferior to liberal, thus lowering the transfusion triggers, both on-pump and off-pump. The decision to transfuse should be based on a combination of physiological transfusion triggers, reviewed with the overall clinical context (hemodynamic parameters, urine output, medical history, age, gender, etc.). It is important to avoid premature transfusion and maintain adequate tissue oxygen supply to organs at risk (85.71% Strongly agree; 14.29% Agree; SD = 0.35).

R17. In centers where viscoelastic testing is not available, the standard laboratory intraoperative blood management should be targeted toward maintaining 5 key parameters: Hemoglobin (Hb) >7.5 g/dL, platelets >50,000/microL, international normalized ratio (INR) < 1.5, fibrinogen >150 mg/dL, and ACT not more than baseline [Flowchart 2 and Box 1] (62.5% Strongly agree; 37.5% Agree; SD = 0.484).

Box 1: Working Group’s considerations for patient blood management based on transfusion triggers and conventional laboratory tests.
  • Patients undergoing CPB should be gradually rewarmed to 36°C once the surgical procedure on CPB is completed. Subsequently, platelet count, clauss fibrinogen assay, and viscoelastic assessment should be tested.

  • Following separation from CPB, heparin should be reversed using protamine sulfate at a dose of 0.5–1 mg per unit of initial heparin dose, with the objective of normalizing ACT to the pre-CPB baseline.

  • If rebound heparinization is suspected due to an increase in ACT after correction to baseline, a protamine infusion of 25 mg/h should be initiated and administered over 4 h.i

  • In cases of persistent bleeding after discontinuation of CPB and reversal of heparin with normalization of ACT, chest packing should be performed, and any coagulopathy corrected.

  • The perioperative care team should aim for a target hemoglobin level between 8 and 10 g/dl, depending on patient comorbidities and the rate of bleeding.

  • Prioritize the correction of fibrinogen levels using Clauss fibrinogen assay levels of≤200–250 mg/dL. Administer fibrinogen concentrate, which is as effective as cryoprecipitate for this purpose. Target fibrinogen repletion between 200 and 250 mg/dL using fibrinogen concentrate to enhance fibrin cross-linkage, optimize clot strength, and facilitate the hemostatic effect of thrombin generation. However, be cautious to avoid overcorrection of fibrinogen levels.

  • Next, correct platelet levels if bleeding persists and the INR is>1.5–2. Administer one dose of platelets if platelet count is<100 k. Administer two doses of platelets if platelet count is<50 k or if deep hypothermia and circulatory arrest are observed.

  • Consider rFVIIa for patients with intractablebleeding after conventional hemostatic therapy, while being mindful of the risk of thrombosis. If bleeding persists after PCC administration, administer low-dose rFVIIa at the discretion of the supervising anesthesiologist.

  • If bleeding is not controlled, surgical re-exploration may be considered as guided by hemodynamic status and available imaging modalities.

  • Once hemostasis is achieved, transfer all cardiac surgical patients to a CTICU

ACT: Activated clotting time, INR: International normalized ratio, CTICU: Cardiothoracic intensive care unit, CPB: Cardiopulmonary bypass, , rFVIIa: Recombinant activated factor VII

(Hashmi NK, et al.)

Intraoperative algorithm for cardiac surgery targeted transfusion (Non-thromboelastography/rotational thromboelastometry directed transfusion modalities available in India). ACT: Activated clotting time, ANH: Acute normovolemic hemodilution, CPB: cardiopulmonary bypass, DDAVP: 1-deamino-8-d-arginine vasopressin, FFP: Fresh-frozen plasma, Hb: Hemoglobin, ica++: Ionized calcium, INR: International normalized ratio, PCC: Prothrombin complex concentrate, PLT: Platelets, RBC: Red blood cell, rFVIIa: Recombinant activated factor VII, RV: Right ventricle, T: Temperature. Source: With permission from Raphael J, et al.
Flowchart 2:
Intraoperative algorithm for cardiac surgery targeted transfusion (Non-thromboelastography/rotational thromboelastometry directed transfusion modalities available in India). ACT: Activated clotting time, ANH: Acute normovolemic hemodilution, CPB: cardiopulmonary bypass, DDAVP: 1-deamino-8-d-arginine vasopressin, FFP: Fresh-frozen plasma, Hb: Hemoglobin, ica++: Ionized calcium, INR: International normalized ratio, PCC: Prothrombin complex concentrate, PLT: Platelets, RBC: Red blood cell, rFVIIa: Recombinant activated factor VII, RV: Right ventricle, T: Temperature.
Source: With permission from Raphael J, et al.

To control bleeding, it is imperative to first control general physiological conditions leading to bleeding such as hypothermia, acidosis, and CPB-induced hyperfibrinolysis. The use of antifibrinolytics should be judiciously managed in the ICU as well, especially when post-protamine, excessive bleeding continues to manage microvascular bleeding, important to monitor Hb, platelets, INR, fibrinogen, and ACT as required. Most patients require a single blood component, post-investigations, but some ongoing coagulopathy patients may require more than one blood component for good hemostasis. Clinical assessment is most fundamental during ongoing component therapy.[3]

R18. When TEG ROTEM-guided transfusion protocols are followed in cardiac surgery from beginning to end, the blood transfusion quantities are diminished. The two ROTEM and TEG share a similar basic principle of viscoelastic testing with some differences in the mechanical functioning [Table 1]. The ROTEM has the cup fixed and the TEG has a cup which oscillates to a fixed pin.[15] Algorithms used for viscoelastic testing (VET) optimize need for blood transfusion even in the ICU and contribute greatly in achieving patient blood management strategies of restricted blood transfusion and avoidance of complications of blood transfusion and thus target appropriate quantity of patient care (62.5% Strongly agree; 37.5% Agree; SD = 0.484).[16]

Table 1: Comparison of TEG versus ROTEM parameters.
ROTEM TEG Hemostatic factors
Clot initiation CT (clotting time) in seconds R (reaction time) in minutes Enzymatic Coagulation Factors, anticoagulants, FDPs, tissue factor expression on monocytes
Clot kinetics CFT in seconds; alpha angle in degrees K (kinetic time) in min; alpha angle in degrees Enzymatic coagulation factor, anticoagulants, fibrinogen, platelets
Clot strength A5 (A10) Amplitude in min after CT in mm, MCF in mm MA in mm Platelets, fibrinogen, FXIII, Colloids
Clot stability (lysis) LI60 (Lysis Index 60 min after CT in % of MCF LY30 (lysis 30 min after MA) in % of MA Fibrinolytic enzymes, fibrinolysis inhibitors, FXIII

A5 indicates amplitude 5 min after coagulation time, A10: Amplitude 10 min after coagulation time, CFT: Clot formation time, CT: Coagulation time, MA:Maximum amplitude, MCF: Maximum clot firmness, ML: Maximum lysis during run time, ROTEM: Rotational thromboelastometry, TEG: Thrombelastography, FDPs: Fibrin degradation products

R18.1 TEG-guided bleeding management: The TEG-based values and corresponding treatment protocol are shown in Table 2 and the TEG protocol for management of bleeding during cardiac surgery is shown in Flowchart 3.[17]

Table 2: TEG-based values and treatment protocol.
Parameter Treatment values Treatment protocol
R (TEG) R>15 min 2 units of FFP
R>10 min FFP titrated over repeat TEG assays
R<4 min Anticoagulation
R: 11–14 min 2 units FFP
R>14 min 4 units FFP
R>10 min FFP 10 mL/kg IBW
ACT (RapidTEG w/tissue factor) Initial ACT>111–139s Protamine 0.4 mg/kg or 2 units FFP
Initial ACT>140s 2 units FFP+10-pack Cryo
Subsequent ACT>110s 2 units FFP
α-angle (TEG) α<45° 5 units Cryo
α-angle (RapidTEG) α<63° 10-pack Cryo
MA (TEG) MA<40 mm 10 units platelets
MA<55 mm 1 unit platelet apheresis
MA>73 mm Antiplatelet therapy
MA: 46–54 mm 0.3 µg/kg DDAVP
MA: 41–45 mm 1 unit platelet apheresis
MA≤40 mm 2 units of platelet apheresis
MA<55 mm 1 unit platelet apheresis
MA (RapidTEG) MA<55 mm 1 unit platelet apheresis
Ly30 (RapidTEG) Ly30≥7.5% (later reduced to≥3%) Tranexamic acid 1 g IV

TEG: Thrombelastography, FFP: Fresh frozen plasma, ACT: Activated clotting time, Cryo: Cryoprecipitate, MA: Maximum amplitude, DDAVP: 1-deamino-8-d-arginine vasopressin, IBW: Ideal body weight, R: Rapid

Thrombelastography-protocol in the intensive care unit. CPB: Cardiopulmonary bypass, CBC: Complete blood count including red blood cell and platelet counts, PM: Platelet mapping by TEG6s, FibCare: A device that can rapidly measure the fibrinogen levels in the operating room, The following were the TEG6s measurement items: CK-R, CKH-R, CRT-MA, and CFF-MA. FFP: Fresh frozen plasma, MA:Maximum amplitude, RBC: Red blood cell, ACT: Activated clotting time, PC: Platelet count
Flowchart 3:
Thrombelastography-protocol in the intensive care unit. CPB: Cardiopulmonary bypass, CBC: Complete blood count including red blood cell and platelet counts, PM: Platelet mapping by TEG6s, FibCare: A device that can rapidly measure the fibrinogen levels in the operating room, The following were the TEG6s measurement items: CK-R, CKH-R, CRT-MA, and CFF-MA. FFP: Fresh frozen plasma, MA:Maximum amplitude, RBC: Red blood cell, ACT: Activated clotting time, PC: Platelet count

R18.2 ROTEM-guided bleeding management: ROTEM results should be interpreted in a reasonable sequence (A5 FIBTEM before TEXTEM), not according to their availability (TEXTEM before A5 FIBTEM). The sequence should be guided by the clinical situation, followed by hyperfibrinolysis, followed by heparin: protamine balance, clot firmness, and then thrombin generation. This avoids potential misinterpretation of ROTEM results. The TEG/ROTEM-based intraoperative blood management is shown in Flowchart 4 for adult cardiac surgery and Flowchart 5 for congenital cardiac conditions, supported by considerations in Box 2. These flowcharts should be implemented in coordination with the entire multidisciplinary team at the ground level.[18]

Transfusion algorithm during cardiac surgery (Point-of-care testing based). FFP: Fresh frozen plasma, CT: Clotting time, PCC: Prothrombin complex concentrate, TRAPTEM: Thrombin receptor activating peptide-6 assay of ROTEM platelet, ADPTEM:Adenosine diphosphate based thromboelastometry test, INTEM: Intrinsically activated thromboelastometric test, HEPTEM: Heparinase assay based thromboelastometry, ACT: Activated clotting time, ML: Maximum lysis
Flowchart 4:
Transfusion algorithm during cardiac surgery (Point-of-care testing based). FFP: Fresh frozen plasma, CT: Clotting time, PCC: Prothrombin complex concentrate, TRAPTEM: Thrombin receptor activating peptide-6 assay of ROTEM platelet, ADPTEM:Adenosine diphosphate based thromboelastometry test, INTEM: Intrinsically activated thromboelastometric test, HEPTEM: Heparinase assay based thromboelastometry, ACT: Activated clotting time, ML: Maximum lysis
Rotational thromboelastometry protocol as followed in All India Institute of Medical Sciences, for bleeding management in cyanotic congenital heart disease surgical patients. OT: Operation theatre, OP: Operative HGB: Haemoglobin, FFP: Fresh Frozen Plasma, CT: Clotting Time, PCC: Prothrombin Complex Concentrate, INTEM: Intrinsically activated thromboelastometric test, HEPTEM: Heparinase assay based thromboelastometry, ACT: Activated Clotting Time, EXTEM:Extrinsic thromboelastometry
Flowchart 5:
Rotational thromboelastometry protocol as followed in All India Institute of Medical Sciences, for bleeding management in cyanotic congenital heart disease surgical patients. OT: Operation theatre, OP: Operative HGB: Haemoglobin, FFP: Fresh Frozen Plasma, CT: Clotting Time, PCC: Prothrombin Complex Concentrate, INTEM: Intrinsically activated thromboelastometric test, HEPTEM: Heparinase assay based thromboelastometry, ACT: Activated Clotting Time, EXTEM:Extrinsic thromboelastometry
Box 2: Working group’s considerations for using ROTEM/TEG.
  • ROTEM is an accurate and rapid tool for analysis of coagulation pathways.

  • ROTEM/TEG are performed during rewarming phase of the bypass and rechecked after each round of analysis.

  • The diagnostic performance is increased by test combinations, for example, EXTEM and FIBTEM, EXTEM and APTEM, or INTEM and HEPTEM.

  • Fibrinogen concentration drops down first in severe bleeding before thrombin generation is affected (except in bleeding due to anticoagulants or hemophilia).

  • Furthermore, an increase in thrombin generation is associated with a higher risk of thromboembolic complications compared to a substitution of substrates – in particular, fibrinogen.

  • Therefore, clot firmness management, for example, a reduced A5FIBand A5 in EXTEM assay (A5EX), should precede thrombin generation management, for example, a prolonged CTEXand CT in INTEM assay (CTIN).

  • Optimize temperature and continue antifibrinolytics, ANH, mini circuits, retrograde priming, and cell salvage.

  • Intraoperative hemodilution should be used on an individual basis only in patients with a high pre-operative hemoglobin level.

  • Prothrombin complex concentrates are preferable to reverse the effects of Vitamin K antagonists, instead of fresh frozen plasma.

  • Fibrinogen should not be routinely given as prophylaxis.

  • A heparin-to-protamine ratio of 1: 0.6–0.8 should be preferred to avoid residual protamine effects which may lead to increased blood loss, transfusion requirements, and need for re-surgery.

  • rFVIIa should only be considered in cases of uncontrolled, non-surgical bleeding as the last resort with no other therapeutic options remaining.

ROTEM: Rotational thromboelastometry, TEG: Thrombelastography, ANH: Acute normovolemic hemodilution

(Hashmi NK, et al.)

Indian pediatric cardiac surgical studies[19] have shown that algorithm-based blood component therapy led to significantly lower incidence of PRBCs, FFP, platelets, and cryoprecipitate administered and significantly shorter duration of mechanical ventilation, duration of ICU stay, and hospital stay. The Flowchart 5 has been adapted from same study.

R18.3 Targeting platelet aggregation is essential for patients on antiplatelet therapies, including acetylsalicylic acid, P2Y12 adenosine diphosphate receptor blockers, and glycoprotein IIb/IIIa inhibitors. Platelet aggregometry tests are effective for detecting and managing platelet-related bleeding in cardiac surgery.[15,20-32]

R19. All cardiac anesthetists who manage cardiac surgical patients should not only have knowledge of but also be experienced and well-versed with both approaches as mentioned in R17 and R18, that is, both with and without viscoelastic testing facilities available. More so, viscoelastic tests are performed at the bedside, have a short turnaround time, and guide clinicians toward a more goal-directed transfusion management, and hence this working group recommends that more Indian institutes invest in its infrastructure and technical training for viscoelastic monitoring[33,34] (85.71% Strongly agree; 14.29% Agree; SD = 0.433).

Post-operative recommendations

R20. The etiology of excessive blazing is generally due to technical regions, 74% cases ongoing in coagulopathy, 30% combination of both, and 10% cases and miscellaneous others in 3% patients.[12] The need for blood transfusion is felt maximum when the patient has one of the following parameters: Assessment of fluid balance, fluid resuscitation, and bleeding, weaning failure from mechanical ventilation, high doses of vasopressor, and signs of severe ventricular dysfunction[3,35] (75% Strongly agree; 25% Agree; SD = 0.433).

R21. Post-CPB bleeding management is best followed by the Kirklin and Barratt-Boyes criteria,[36] which circulates: the following – (1) when there is drainage as shown in Table 3 and Box 3 (2) when excessive bleeding suddenly restarts indicating a surgical cause or (3) presence of sudden massive bleeding (85.71% Strongly agree; 14.29% Agree; SD = 0.35).

Table 3: Physiological transfusion triggers
1 Haemoglobin (Hb) Restrictive RBC transfusion threshold of Hb 7.5 g/dL is recommended in stable patients,(TRICS trial) whereas patients undergoing high-risk cardiac surgery (ongoing ischaemia, CVA, history of CHF, microvascular bleeding), should be transfused to an Hb of 8-10 g/dL. RBCs should not be transfused at an Hb ≥10 g/dL, with the potential exception of univentricular paediatric cardiac surgery patients. Hb level alone should not dictate transfusion but it should also be based on multiplicity of clinical factors such as rate of Hb decline, cardiopulmonary reserve, amount of acute blood loss being ≥15% of total blood volume, etc. Recently collected RBCs (≤5 days old) should be used in children and neonates and also in adults with end-stage renal disease.
2 Haematocrit A haematocrit of 21–24% may be considered during CPB when an adequate DO2(>273 ml O2/min/m2) level is maintained
3 Tranexamic acid or EACA infusion Tranexamic acid or EACA infusion significantly reduces the proportion of patients who receive allogeneic red blood cell transfusion

RBC: Red blood cells, Hb: Haemoglobin, EACA: Epsilon aminocaproic acid, CPB: Cardiopulmonary bypass, CVA: Cerebrovascular accident, CHF: Congestive heart failure, DO2: Oxygen delivery.

Box 3
Volume of blood drainage Time from surgery
>500 mL During the 1sth
>400 mL During the next 2 h
>300 mL During each of the first 3 h
>1000 mL In total 4 h
>1200 mL In total 5 h

R22. Implement restrictive transfusion trigger just like pre- and intra-operative setting and optimize with correction/optimization of hypothermia, normalize acid-base status and electrolytes, ionized calcium, Mean arterial pressure of 60–75 mm Hg, Positive End-Expiratory Pressure 8–10 cm, checking for chest tube patency, heparin rebound (ACT of 120–140s), Activated Partial Thromboplastin Time, prothrombin time, fibrinogen levels, platelet count, factors, and hyperfibrinolysis. In addition, one must employ anemia tolerance, reduce oxygen consumption, optimize pain control, avoid tachycardia and hypertension, and avoid unnecessary transfusion (top-up transfusion)[37] (100% Strongly agree; SD = 0).

R23. The treatment options used to manage post-operative bleeding are protamine to treat heparin rebound, PRBC, cryoprecipitate, platelet concentrate (random donor/single donor), FFP, fibrinogen concentrate, PCC, tranexamic acid, EACA, desmopressin, and recombinant factor VIIa[38] (77.78% Strongly agree; 22.22% Agree; SD = 0.416).

R24. The transfusion thresholds include PRBC (Hb < 7.5 g/L), platelets (<100 × 103), PCC (INR > 1.5), FFP (INR > 1.5), and fibrinogen (<1.5 g/L)[39] (75% Strongly agree; 25% Agree; SD = 0.433).

R25. Recombinant activated factor VII (rFVIIa) is used as a last resort to treat coagulopathy. rFVIIa should not be used to buy time before re-exploration[40] (57.14% Strongly agree; 42.86% Agree; SD = 0.495).

R26. Topical application of antifibrinolytic agents or fibrin sealant to the surgical site intra operatively is reasonable to reduce blood loss and transfusion requirements[41] (71.43% Strongly agree; 28.57% Agree; SD = 0.452).

DISCUSSION

The World Health Organization has emphasized on the urgency of implementing patient blood management across all surgical procedures.[42] Our recommendations are in line with those and other international recommendations for bleeding management[43-47] and have several strengths as well as limitations as mentioned in Table 4.

Table 4: Strengths and limitations of this recommendation statement.
Strengths Limitations
  1. The Delphi methodology enabled active participation from cardiac anesthesiologists who manage challenging and insufficiently researched bleeding during cardiac surgery.

  2. The working group included highly reputablehealthcare professionals experienced in the daily management of bleeding during cardiac surgery.

  3. The stringent pre-defined criterion of “≥80% agreement” strengthened the results. The first round of Delphi, involving 3 meetings (about 9 h) with in-depth discussions, saw all statements meeting the cut-off without needing further rounds, thanks to pre-work and expert deliberation before voting.

  4. There was 100% retention and 0% attrition through all 3 meetings and corresponding voting.

  1. The Delphi method was limited by a small sample size, but there is no gold standard for panel size, which can vary from 10 to 1000 in published studies. The success of Delphi investigations relies on expert qualification rather than quantity. Strict eligibility criteria ensured the inclusion of high-profile Indian professionals, consistent with the methodology.

  2. The inclusion of only Indian experts was a limitation, as global perspectives could have enriched the findings. However, the Indian experts involved were of international standing, providing valuable insights despite their practice being based in India.

The working group emphasizes that hospital protocols be tailored to available therapeutic options and evidence-based patient blood management lead to better outcomes in cardiac surgeries. As new priorities, infrastructure, treatments, and evidence emerge, revising this consensus will be necessary. Indian hospital protocols should be reviewed annually, considering recent evidence and available blood products, including new factor concentrates. Establishing centers of excellence at key hospitals can help standardize coagulation management and train peripheral centers using a “hub-and-spoke” model. Enhancing the visibility of hospital-based algorithms through mobile apps, websites, or printed stickers can support decision-makers in managing bleeding during cardiac surgery. In addition, efforts must be made to educate anesthesiologists and cardiac surgeons about new factor concentrates, addressing knowledge gaps from medical training.[48-51]

CONCLUSION

Bleeding during cardiac surgery requires a comprehensive, multidisciplinary approach. Limited Indian guidelines, along with constraints in evidence, resources, time, and reimbursement, impede standardized management. This E-Delphi method has, for the first time, produced Indian expert-derived consensus recommendations for managing bleeding in cardiac surgeries. These recommendation statements aim to optimize management approaches, potentially setting a new standard of care in India and beyond.

Acknowledgment

The authors acknowledge the efforts of Dr. Pratishtha Chaudhari for her invaluable support in medical writing, adhering to Good Publication Practice (GPP) guidelines, collating E-Delphi results, and providing essential liaison and coordination assistance for the consensus development. In addition, Dr. Saurabh Suri, a consultant anesthesiologist, shared his expert insights that greatly informed the medical writing process.

Ethical approval:

The Institutional Review Board approval is not required.

Declaration of patient consent:

Patient’s consent not required as there are no patients in this study.

Conflicts of interest:

This is to declare that Dr. Poonam Malhotra Kapoor, Dr. Naman Shastri, Dr. Muralidhar Kanchi, and Dr. Yatin Mehta are on the editorial board of the Journal.

Use of artificial intelligence (AI)-assisted technology for manuscript preparation:

The authors confirm that there was no use of artificial intelligence (AI)-assisted technology for assisting in the writing or editing of the manuscript and no images were manipulated using AI.

Financial support and sponsorship:

The E-Delphi subscription (3 months) and the medical writing support was funded by CSL Behring Pte. Ltd. However, the sponsor had no role in the Delphi process and influence its decision, which involved concept/design, participation in steering committee, execution of the Delphi process, analysis of study findings, development, and submission of the paper for publication. The sponsor did support in organizing the three meetings (one in-person meeting and two virtual meetings).

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