Abstract Number: PB0277
Meeting: ISTH 2020 Congress
Theme: Coagulation and Natural Anticoagulants » Critical Care and Perioperative
Background: 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 simpler to administer and more effective.
Aims: To describe the association of comparable PCC or FP doses with transfusion requirements and adverse outcomes after cardiac surgery.
Methods: This was a post-hoc analysis of the FIBRES randomized controlled trial (Effect of Fibrinogen Concentrate vs. Cryoprecipitate on Blood Component Transfusion after Cardiac Surgery) with ethics approval. The primary outcome was RBC transfusion within 24 hours of CPB. Secondary outcomes included platelet transfusion within 24 hours of CPB and adverse outcomes. Associations were examined with the use of multivariable models adjusted for creatinine clearance, hemoglobin, BMI, age, sex, heart failure, study arm, critical status, surgical complexity and urgency.
Results: Of the 735 patients in FIBRES, 416 received PCC (n=72, 17%) or FFP (n=344, 83%) (Table 1). A total of 66 (16%) experienced thromboembolic events and 54 (13%) fluid overload or respiratory events within 28 days; 145 (35%) renal events within 7 days; 78 (19%) surgical re-exploration. Each unit of FP was associated with increased adjusted odds (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]. 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]. PCC use was not associated with an increase in adverse events (Figure 1).
Conclusions: PCC use was associated with transfusion avoidance, without increases in adverse events. PCCs appear to confer hemostatic advantages to FP in this setting, however randomized trials are needed.
| Variable | Frozen Plasma Only (n=344) | Prothrombin Complex Concentrates Only (n=72) | P-Value |
| Age, Median (IQR), y | 66 (58, 73) | 65 (42, 72) | 0.03* |
| Body mass index, Median (IQR) | 23 (20, 26) | 21 (18, 24) | <0.01* |
| Creatinine Clearance, Median (IQR), ml/min | 71 (45, 97) | 71 (48, 104) | 0.71 |
| Hemoglobin, Median (IQR), g/L | 132 (116, 144) | 132 (113, 146) | 0.94 |
| International Normalized Ratio, Median (IQR) | 1.0 (1.0, 1.2) | 1.1 (1.0, 1.3) | 0.30 |
| Left ventricular ejection fraction < 21% | 13 (4%) | 4 (6%) | 0.37 |
| Pulmonary hypertension (%) | 65 (25%) | 17 (24%) | 0.83 |
| Cerebrovascular Disease (%) | 40 (12%) | 12 (17%) | 0.24 |
| Critical Pre-Operative Status (%) | 77 (22%) | 16 (22%) | 0.98 |
[Table 1. Characteristics of the Study Population at Baseline]
[Figure 1. The Adjusted Association of PCC (per 500 Units) or FP (per 1 Unit) Dose with Postoperative Outcomes ]
To cite this abstract in AMA style:
Bartoszko J, Karkouti K, Callum J, on Behalf of the FIBRES Study Investigators . The Association of Prothrombin Complex Concentrates with Transfusion Requirement and Postoperative Outcomes in Cardiac Surgery: A Post-Hoc Analysis of the FIBRES Randomized Controlled Trial [abstract]. Res Pract Thromb Haemost. 2020; 4 (Suppl 1). https://abstracts.isth.org/abstract/the-association-of-prothrombin-complex-concentrates-with-transfusion-requirement-and-postoperative-outcomes-in-cardiac-surgery-a-post-hoc-analysis-of-the-fibres-randomized-controlled-trial/. Accessed September 21, 2023.« Back to ISTH 2020 Congress
ISTH Congress Abstracts - https://abstracts.isth.org/abstract/the-association-of-prothrombin-complex-concentrates-with-transfusion-requirement-and-postoperative-outcomes-in-cardiac-surgery-a-post-hoc-analysis-of-the-fibres-randomized-controlled-trial/