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 @ 2:13 AM
Ignite Modification Date:
2025-12-25 @ 2:13 AM
NCT ID:
NCT07195760
Eligibility Criteria:
Inclusion Criteria:
* Minimal (defined according to the Head Injury Severity Score (HISS (Stein and Spettell 1995)) as GCS 15 without any risk-factors) or Mild head trauma (defined according to the HISS as a GCS score of 14 or 15 with risk factors (e.g. OAC-treatment, GCS = 14, repeated vomiting, loss of consciousness, age ≥ 65 and antiplatelet medication))
* No bleeding on initial head CT description
Exclusion Criteria:
* Other reasons for observation despite normal CT, based on the Scandinavian guidelines for initial management of minimal, mild and moderate head injuries in adults:
* GCS \< 14
* Post traumatic seizures
* Focal neurological deficits
* Clinical sign of depressed or basal skull fracture
* Shunt-treated hydrocephalus
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT07195760
Study Brief:
Protocol Section:
NCT07195760