Status:
NOT_YET_RECRUITING
Pre-hospital Administration of Fibrinogen in Trauma-Induced Coagulopathy
Lead Sponsor:
Unidade Local de Saude do Arco Ribeirinho
Collaborating Sponsors:
Unidade Local de Saúde de São José
Unidade Local de Saúde da Arrábida
Conditions:
Trauma Induced Coagulopathy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
A prospective, randomized controlled trial of fibrinogen concentrate (FC) plus standard of care versus standard of care alone in adult trauma patients with major bleeding or presumed major bleeding is...
Detailed Description
Pre-hospital Administration of Fibrinogen Concentrate in Patients with Suspected Trauma-Induced Coagulopathy (PAF-TIC) Introduction Trauma is a leading cause of morbidity and mortality worldwide, wit...
Eligibility Criteria
Inclusion
- • 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
- 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)
Key Trial Info
Start Date :
January 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT06582420
Start Date
January 1 2025
End Date
December 31 2025
Last Update
September 19 2024
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