| Autor: |
Bouzat, Pierre, Charbit, Jonathan, Abback, Paer-Selim, Huet-Garrigue, Delphine, Delhaye, Nathalie, Leone, Marc, Marcotte, Guillaume, David, Jean-Stéphane, Levrat, Albrice, Asehnoune, Karim, Pottecher, Julien, Duranteau, Jacques, Courvalin, Elie, Adolle, Anais, Sourd, Dimitri, Bosson, Jean-Luc, Riou, Bruno, Gauss, Tobias, Payen, Jean-François |
| Předmět: |
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| Zdroj: |
JAMA: Journal of the American Medical Association; 4/25/2023, Vol. 329 Issue 16, p1367-1375, 9p |
| Abstrakt: |
Key Points: Question: Does 4-factor prothrombin complex concentrate (4F-PCC) reduce 24-hour blood product consumption in patients with trauma at risk of massive transfusion? Findings: In this superiority randomized trial involving 324 patients, there was no difference in total 24-hour blood product consumption among patients treated with 4F-PCC (12 U) vs placebo (11 U). More thromboembolic events occurred in the 4F-PCC group. Meaning: These findings do not support the administration of 4F-PCC in patients with trauma at risk of massive transfusion. Importance: Optimal transfusion strategies in traumatic hemorrhage are unknown. Reports suggest a beneficial effect of 4-factor prothrombin complex concentrate (4F-PCC) on blood product consumption. Objective: To investigate the efficacy and safety of 4F-PCC administration in patients at risk of massive transfusion. Design, Setting, and Participants: Double-blind, randomized, placebo-controlled superiority trial in 12 French designated level I trauma centers from December 29, 2017, to August 31, 2021, involving consecutive patients with trauma at risk of massive transfusion. Follow-up was completed on August 31, 2021. Interventions: Intravenous administration of 1 mL/kg of 4F-PCC (25 IU of factor IX/kg) vs 1 mL/kg of saline solution (placebo). Patients, investigators, and data analysts were blinded to treatment assignment. All patients received early ratio-based transfusion (packed red blood cells:fresh frozen plasma ratio of 1:1 to 2:1) and were treated according to European traumatic hemorrhage guidelines. Main Outcomes and Measures: The primary outcome was 24-hour all blood product consumption (efficacy); arterial or venous thromboembolic events were a secondary outcome (safety). Results: Of 4313 patients with the highest trauma level activation, 350 were eligible for emergency inclusion, 327 were randomized, and 324 were analyzed (164 in the 4F-PCC group and 160 in the placebo group). The median (IQR) age of participants was 39 (27-56) years, Injury Severity Score was 36 (26-50 [major trauma]), and admission blood lactate level was 4.6 (2.8-7.4) mmol/L; prehospital arterial systolic blood pressure was less than 90 mm Hg in 179 of 324 patients (59%), 233 patients (73%) were men, and 226 (69%) required expedient hemorrhage control. There was no statistically or clinically significant between-group difference in median (IQR) total 24-hour blood product consumption (12 [5-19] U in the 4F-PCC group vs 11 [6-19] U in the placebo group; absolute difference, 0.2 U [95% CI, −2.99 to 3.33]; P =.72). In the 4F-PCC group, 56 patients (35%) presented with at least 1 thromboembolic event vs 37 patients (24%) in the placebo group (absolute difference, 11% [95% CI, 1%-21%]; relative risk, 1.48 [95% CI, 1.04-2.10]; P =.03). Conclusions and Relevance: Among patients with trauma at risk of massive transfusion, there was no significant reduction of 24-hour blood product consumption after administration of 4F-PCC, but thromboembolic events were more common. These findings do not support systematic use of 4F-PCC in patients at risk of massive transfusion. Trial Registration: ClinicalTrials.gov Identifier: NCT03218722 This randomized clinical trial examines whether systematic 4-factor prothrombin complex concentrate administration combined with a ratio-based transfusion protocol is superior to ratio-based transfusion alone in reducing 24-hour total blood product consumption in patients at risk of massive transfusion. [ABSTRACT FROM AUTHOR] |
| Databáze: |
Complementary Index |
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