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99 The Association of Prothrombin Complex Concentrates with Transfusion Requirement and Postoperative Outcomes in Cardiac Surgery: A Post-Hoc Analysis of the Fibres Randomized Controlled TrialClinically Relevant Abstract

Program: Oral and Poster Abstracts
Type: Oral
Session: 401 Basic Science and Clinical Practice in Blood Transfusion: COVID-19 Convalescent Plasma, Antigen Typing and the Prothrombin Complex II
Hematology Disease Topics & Pathways:
Non-Biological, Therapies, coagulant drugs, Clinically relevant, pharmacology
Saturday, December 5, 2020: 9:30 AM

Justyna Bartoszko, MD, MSc, FRCPC1*, Keyvan Karkouti, MD, MSc, FRCPC1* and Jeannie Callum, MD, FRCPC2

1Department of Anesthesiology and Pain Medicine, Toronto General Hospital, University Health Network, University of Toronto, Toronto, ON, Canada
2Department of Laboratory Medicine and Molecular Diagnostics, Sunnybrook Health Sciences Centre, Toronto, Canada

Background and Goal of Study

Coagulopathy after cardiopulmonary bypass (CPB) is common and associated with bleeding and adverse outcomes. The mainstay of therapy for coagulation factor deficiency is frozen plasma (FP), however prothrombin complex concentrates (PCCs) may be more effective and logistically simpler to administer. We sought to describe the association of comparable PCC or FP doses with transfusion requirements and adverse outcomes after CPB surgery.

Materials and Methods

This was a post-hoc analysis of the FIBRES (Effect of Fibrinogen Concentrate vs. Cryoprecipitate on Blood Component Transfusion after Cardiac Surgery) randomized controlled trial. The predictors of interest were dose of PCC or FP within 24 hours of CPB. Patients who received only PCC or only FP were included. The primary outcome was RBC transfusion within 24 hours of CPB. Secondary outcomes included platelet transfusion within 24 hours of CPB and adverse post-operative outcomes. Each association was examined by generalized estimating equation models for either count (Poisson) or binary (Logistic) data, which were adjusted for pre-operative creatinine clearance, hemoglobin level, BMI, age, sex, presence of heart failure, study arm, critical pre-operative status of the patient, and surgical complexity and urgency.

Results and Discussion

Of the 735 patients included in FIBRES, 416 with significant post-CPB bleeding received PCC (n=72, 17%) or FFP (n=344, 83%) at 11 Canadian institutions from 2017 to 2018 (31% female; 77% complex surgery; 39% urgent; 22% critical pre-operative status). Two patients who received PCC but for whom dosing was not available were excluded. The median number of RBC units transfused was 3 [Interquartile Range (1, 5)] and platelet pools was 2 [Interquartile Range (1, 3)]. A total of 66 (16%) patients experienced thromboembolic events within 28 days, 54 (13%) fluid overload or respiratory events within 28 days, 145 (35%) renal events within 7 days, and 78 (19%) required surgical re-exploration. Each unit of FP was associated with an increased adjusted odds ratio (aOR) of RBC transfusion [aOR 1.50 (95% CI, 1.29, 1.75), p<0.01], while each 500 units of PCC was protective [aOR 0.70 (95% CI, 0.60, 0.83), p<0.01]. Similarly, each unit of FP was associated with an increased adjusted odds of platelet transfusion [aOR 1.41 (95% CI 1.14, 1.73), p<0.01], while each 500 units of PCC was protective [aOR 0.81 (95% CI, 0.71, 0.93), p<0.01]. Results are presented in Table 1. There was no increase in adverse events with PCC use compared to FP, with 17% of patients receiving PCC experiencing thromboembolic events compared to 16% in the FP group.


In cardiac surgical patients with post-CPB bleeding, PCC use was associated with decreased RBC and platelet transfusion compared to FP, without a significant increase in adverse events. In this off-label setting, PCCs appear to confer hemostatic advantages to FP.

Disclosures: Karkouti: Octapharma: Research Funding; Canadian blood services: Research Funding. Callum: Canadian Blood Services: Research Funding; Octapharma Canada: Research Funding.

OffLabel Disclosure: Indications for Octaplex (four factor prothrombin complex concentrates) include urgent reversal of acquired deficiency of prothrombin complex coagulation factors such as vitamin K antagonists in the setting of bleeding or prophylaxis prior to a surgery or intervention that may lead to bleeding.

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*signifies non-member of ASH