Pre-hospital Administration of Fibrinogen in Trauma-Induced Coagulopathy

Launched by UNIDADE LOCAL DE SAUDE DO ARCO RIBEIRINHO · Aug 30, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the use of a treatment called fibrinogen concentrate (FC) in adults who have serious injuries and are experiencing major bleeding or are at risk of bleeding. The goal is to see if giving FC before patients reach the hospital can help improve their blood clotting and overall outcomes compared to standard care alone. Researchers will look at the levels of fibrinogen in the blood when patients arrive at the trauma room and check how feasible it is to administer this treatment before getting to the hospital.

To be eligible for this trial, participants must be adults who show signs of a condition called Trauma Induced Coagulopathy (TIC), meaning they have major bleeding or are likely to bleed a lot. Specific criteria include a certain score based on their trauma and shock levels. However, individuals who have certain conditions, such as severe bleeding from only a head injury or known allergies to the treatment, will not be included. If a person joins the trial, they will either receive standard trauma care or standard care plus the fibrinogen concentrate. The trial is not yet recruiting patients, but it aims to help improve treatment options for people with serious bleeding injuries in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • • Adult patients at risk of Trauma Induced Coagulopathy (TIC), with major bleeding or presumed to be bleeding, identified by TIC criteria: mTICCS score \> 5 or Shock index \> 0.8.
• Exclusion Criteria:
• • Known adverse reactions to fibrinogen concentrate (FC)
• • Isolated trauma such as traumatic head injury only
• • Need for cardiopulmonary resuscitation (CPR) on the scene or peri-arrest scenarios
• • Deep hypothermia
• • Age below 18 years
• • Pregnancy
• • Prothrombin time ratio superior equal or superior to 1.2 (PTr\>1.2) at the hospital admission
• • Refusal to participate (if the patients are capable of consenting)