Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:22 AM
Ignite Modification Date:
2025-12-25 @ 4:22 AM
NCT ID:
NCT06582420
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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06582420
Study Brief:
Protocol Section:
NCT06582420