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:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2025-12-24 @ 9:16 PM
NCT ID:
NCT02379104
Eligibility Criteria:
Inclusion Criteria:
Patients:
* Age ≥ 18 years
* Informed written consent
* Patients with an acute bleeding during surgery
* Or: trauma patients with acute bleeding
* Or: hypercoagulable (above normal fibrinogen) patients at the ICU
Healthy Volunteers:
* Adult healthy individuals (≥ 18 years)
* Written informed consent
Exclusion Criteria:
Patients:
• none
Healthy Volunteers:
* Any indications of alcohol or illegal drug abuse
* Any chronic disease with possible effect on the coagulation (liver disease, coronary heart disease)
* Any acute illness within the last 14 days
* Any hemostasis associated disease (myocardial infarction, thrombosis , stroke etc.) within the last year
* Intake of any coagulation affecting medication (aspirin, pain-killers, anti-rheumatic drugs, marcumar, platelet inhibitors) within the last 14 days
* Females only: known pregnancy
* Females only: breast feeding
* Any indication for any hemostasis disorder as interrogated by a specific history of bleeding tendencies
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02379104
Study Brief:
Protocol Section:
NCT02379104