Fibrinogen Early In Severe Trauma StudY II Comparing Fibrinogen Concentrate and Cryoprecipitate in Adults with Major Haemorrhage

What this Trial Is About

Severe trauma can cause heavy bleeding and changes in blood clotting that make it hard for injured patients to stop bleeding effectively. This trial focuses on adults with severe trauma who experience low fibrinogen levels, a key clotting factor, to compare two ways of replacing fibrinogen during major bleeding. The study aims to evaluate the safety, effectiveness, and cost of fibrinogen concentrate versus cryoprecipitate, which is the current standard treatment made from donated blood. Participants will be randomly assigned to one of two groups: one will receive fibrinogen concentrate, a dry powder that can be quickly prepared and given at the bedside, and the other will receive cryoprecipitate, which requires thawing before use and contains multiple clotting factors. Dosing is guided by specific clotting tests measuring fibrinogen levels. The study includes 850 patients from trauma centers in Australia and New Zealand and follows them for outcomes after treatment. During the study, researchers will monitor participants' days alive and out of hospital up to 90 days after injury, along with other measures like blood transfusion amounts, mortality rates, organ failure, and quality of life over 12 months. Safety is assessed by tracking blood clot-related events and other complications. This phase III randomized trial uses blinded methods to ensure reliable results and includes careful follow-up to understand the impact of fibrinogen replacement in traumatic bleeding.

Fibrinogen Early In Severe Trauma StudY II