Efficacy and Safety of Early Administration of 4-Factor Prothrombin Complex Concentrate in Patients With Trauma at Risk of Massive Transfusion: The PROCOAG Randomized Clinical Trial

Bouzat, P; Charbit, J; Abback, PS; Huet-Garrigue, D; Delhaye, N; Leone, M; Marcotte, G; David, JS; Levrat, A; Asehnoune, K; Pottecher, J; Duranteau, J; Courvalin, E; Adolle, A; Sourd, D; Bosson, JL; Riou, B; Gauss, T; Payen, JF; PROCOAG Study Group

doi:10.1001/jama.2023.4080

Trauma & major bleeding

Efficacy and Safety of Early Administration of 4-Factor Prothrombin Complex Concentrate in Patients With Trauma at Risk of Massive Transfusion: The PROCOAG Randomized Clinical Trial

JAMAPublished 25 Apr 2023Randomised controlled trial

Primary result · Total 24-hour blood product consumptionResultAbsolute difference 0.2 U 95% CI −2.99 to 3.33

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Authors' conclusion

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.

Study context

Population: Consecutive trauma patients at risk of massive transfusion; all received early ratio-based transfusion and care per European traumatic hemorrhage guidelines324 analysed
Participants: 327 patients

Comparison: 4F-PCC 1 mL/kg vs saline placebo 1 mL/kg
4F-PCCn = 164
Placebon = 160reference
Primary endpoint: All blood product consumption
Follow-up: 24 hours

Methodological detailsdouble-blind, placebo-controlled, superiority, multicentre (12 French level I trauma centres)

Double-blind
Placebo-controlled
Superiority
Multicentre (12 French level I trauma centres)

Primary result

Total 24-hour blood product consumption

Absolute difference

0.2 U

95% CI −2.99 to 3.33

P = 0.72

By group

4F-PCC12median · IQR 5–19 · U

Placebo11median · IQR 6–19 · U

4F-PCC vs Placebo

absolute difference 0.2 U (95% CI −2.99 to 3.33); P = 0.72

As reported in the abstract

Safety

Outcome	4F-PCC	Placebo	← Lower with 4F-PCC ←→ Higher with 4F-PCC →	Absolute difference (%) (95% CI)
≥1 arterial or venous thromboembolic event	35%	24%	−100102030	11 (1%–21%)
			−100102030Difference, % (linear scale)

Outcome	← Lower risk with 4F-PCC ←→ Higher risk with 4F-PCC →	RR (95% CI)	P value
≥1 arterial or venous thromboembolic event	0.512	1.48 (1.04–2.10)	P = 0.03
	0.512Relative risk (log scale)

Original publication

Efficacy and Safety of Early Administration of 4-Factor Prothrombin Complex Concentrate in Patients With Trauma at Risk of Massive Transfusion: The PROCOAG Randomized Clinical Trial. JAMA. Published 25 April 2023. doi:10.1001/jama.2023.4080

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