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 @ 2:01 AM
Ignite Modification Date:
2025-12-25 @ 2:01 AM
NCT ID:
NCT04489160
Eligibility Criteria:
Inclusion Criteria:
* Age at admission ≥ 18 years and \< 65 years;
* Clinical diagnosis of traumatic brain injury with GCS \< 13 (with intracranial deviations);
* Catheter placement for monitoring and management of increased ICP for at least 24 hours;
Exclusion Criteria:
* A clear, non-traumatic cause of low GCS (e.g. toxic, cardial) on admission;
* Not expected to survive more than 24 hours after admission;
* Brain death on arrival in the participating centers;
* Severe pre-trauma disability, defined as being dependent on other people;
* Known prior history of sensibility to blood products or Cinryze;
* Patients with a history of hereditary angioedema;
* Patients with a history of thrombosis;
* Pregnant women.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT04489160
Study Brief:
Protocol Section:
NCT04489160