Lay summary
The Fibrinogen Early In Severe Trauma StudY (FEISTY-II) trial is a research study that aims to improve treatment for people with severe bleeding after major trauma. When someone has major bleeding, fibrinogen, a protein that helps blood clot, can drop to dangerously low levels. The study will compare two methods of replacing fibrinogen: a newer treatment called fibrinogen concentrate and the standard treatment, cryoprecipitate. The study will involve 842 adult participants across Australia & New Zealand who are actively bleeding and have low fibrinogen levels. Participants will be randomly assigned to receive either fibrinogen concentrate or cryoprecipitate. Researchers will measure the effectiveness of each treatment by looking at how many days participants are alive and out of hospital within 90 days after their injury. This trial could lead to better care for people with severe trauma by identifying the most effective and efficient way to manage life-threatening bleeding, potentially saving lives and improving recovery outcomes.