Add-on high-dose cryoprecipitate of no benefit to patients with trauma, bleeding

When added to standard care, early and empirical treatment with high-dose cryoprecipitate does not appear to improve clinical outcomes in patients with trauma and bleeding, according to the CRYOSTAT-2 study.

CRYOSTAT-2 enrolled 1,604 adult patients across 26 UK and US major trauma centres. The inclusion criteria included requirement of activation of the hospital’s major haemorrhage protocol with evidence of active haemorrhage, systolic blood pressure (SBP) <90 mm Hg at any time, and receipt of at least 1 U of a blood component transfusion.

The patients were randomly assigned to receive standard care, which was the local major haemorrhage protocol (reviewed for guideline adherence), alone (n=805) or in addition to cryoprecipitate (n=799). For patients in the combination arm, three pools of cryoprecipitate (6-g fibrinogen equivalent) were administered within 90 minutes of randomization and 3 hours of injury.

Of the patients, 1,531 patients (95 percent, median age 39 years, 79 percent men) were included in the primary analysis population. Their median Injury Severity Score was 29, and 36 percent of patients had penetrating injury and 33 percent had SBP <90 mm Hg at hospital arrival.

The primary outcome of all-cause mortality at 28 days was similar in the two treatment groups: 26.1 percent in the standard care group vs 25.3 percent in the cryoprecipitate group (odds ratio, 0.96, 95 percent confidence interval [CI], 0.75-1.23; p=0.74). Likewise, there was no significant difference in safety outcomes or incidence of thrombotic events in the standard care vs cryoprecipitate group (12.9 percent vs 12.7 percent).