Early Administration of Prothrombin Concentrate Complex in Patients With Acute Hemorrhage Following Severe Trauma - PROCOAG

Apr 18, 2023
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
French Ministry of Health Programme Hospitalier de Recherche Clinique Inter-regional 2015
Date Published:
03/21/2023
Original Posted Date:
04/18/2023
References

Contribution To Literature:

The PROCOAG trial failed to show that 4F-PCC reduces transfusion requirements among trauma patients.

Description:

The goal of the trial was to evaluate 4-factor prothrombin complex concentrate (4F-PCC) compared with placebo among trauma patients at risk of massive transfusion.

Study Design

  • Randomization
  • Parallel
  • Placebo

Trauma patients were randomized to 4F-PCC (n = 165) vs. placebo (n = 162).

  • Total number of enrollees: 327
  • Duration of follow-up: In-hospital
  • Mean patient age: 39.5 years
  • Percentage female: 29%

Inclusion criteria:

  • Patients (≥18 years of age) with trauma at risk of massive transfusion

Exclusion criteria:

  • Traumatic cardiac arrest
  • Devastating injuries with expected death within an hour or preinjury terminal condition
  • Secondary admission from another health care facility
  • Preinjury treatment with anticoagulants
  • Known pregnancy
  • Known hypersensitivity to 4F-PCC
  • Patient under guardianship
  • Inclusion in another trial within the last 30 days
  • Patients without health insurance

Principal Findings:

The primary outcome, total blood product consumption, was a median of 12 units in the 4F-PCC group vs. 11 units in the placebo group (p = 0.72).

Secondary outcomes:

  • At least 1 thromboembolic event: 35% in the 4F-PCC group vs. 24% in the placebo group (p = 0.03)

Interpretation:

Among patients with trauma, 4F-PCC failed to reduce the need for blood product transfusion. Moreover, 4F-PCC was associated with an increased risk of thromboembolic events. This trial does not support the systematic use of 4F-PCC in patients at risk of massive transfusion.

References:

Bouzat P, Charbit J, Abback PS, et al., on behalf of the PROCOAG Study Group. 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 2023;Mar 21:[Epub ahead of print].

Clinical Topics: Anticoagulation Management, Prevention

Keywords: Anticoagulants, Emergency Medicine, Factor Xa Inhibitors, Hemorrhage, Platelet Transfusion, Prothrombin, Risk, Secondary Prevention, Thromboembolism


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