The addition of early and empirical high-dose cryoprecipitate to usual care does not improve clinical outcomes in patients with trauma and bleeding who required activation of a major hemorrhage protocol (MHP).
CRYOSTAT-2 was an interventional, randomized, open-label, parallel-group controlled, international, multicenter study.
A total of 1604 patients were enrolled from 25 major trauma centers in the United Kingdom (n=1555) and 1 in the United States (n=49) between August 2017 and November 2021.
A total of 805 patients were randomly assigned to receive the standard MHP (standard care), and 799 were randomly assigned to receive an additional three pools of cryoprecipitate.
The primary outcome was all-cause mortality at 28 days.
Addition of early cryoprecipitate vs standard care did not improve all-cause 28-day mortality in the intent-to-treat population (25.3% vs 26.1%; P = .74).
In patient subgroup with penetrating trauma, 28-day mortality was significantly higher in the cryoprecipitate group than in the standard care group (16.2% vs 10.0%; odds ratio, 1.74; P = .006).
Massive transfusion (RBC ≥10 U) was similar between the cryoprecipitate and standard care groups.
According to the authors, it is possible that certain patients may have benefited from cryoprecipitate, but they did not receive it promptly or in adequate doses to restore functional fibrinogen levels. Despite the study’s goal of early cryoprecipitate administration, the median time to the first transfusion exceeded 1 hour after the patient’s arrival, which highlights the logistical challenges of preparing and delivering a frozen blood component from a distant blood laboratory to the patient.
The study, with first author Ross Davenport, PhD, of Queen Mary University of London, London, United Kingdom and colleagues, was published on October 12 in the JAMA.
There was variability of timing of cryoprecipitate administration and an overlap with patients in the standard care group receiving the intervention as part of their usual MHP treatment.
The study was funded by the UK National Institute for Health and Care Research: Health Technology Assessment and Barts Charity, UK.
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Cite this: Early Cryoprecipitate Fails to Improve Trauma Hemorrhage Outcomes – Medscape – Nov 06, 2023.
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Publish date : 2023-11-06 08:37:55
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