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 @ 11:41 PM
Ignite Modification Date:
2025-12-24 @ 11:41 PM
NCT ID:
NCT02836951
Eligibility Criteria:
Inclusion Criteria:
* Patient is hospitalized because of a head trauma and suspected TBI.
* Age 18 or above. The subject (including the control subjects) must be an independent adult who is not under guardianship.
* The patient, or the next of kin in the case of an incompetent person, has signed the Informed consent. This concerns the control subjects, too.
* The samples can be collected during regular office hours.
* The patient needs lumbar puncture for treatment reasons. This is not a limiting criterion however. If it is difficult to find an adequate number of patients for lumbar puncture, CSF samples of some patients can be omitted after the study coordinator's consideration.
Exclusion Criteria:
* The subject has been found positive for HIV or hepatitis-B in the involved laboratory studies.
* The subject has a chronic mental disorder which is mentioned on the sickness insurance card.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02836951
Study Brief:
Protocol Section:
NCT02836951