Status:
ACTIVE_NOT_RECRUITING
Delayed IntraCranial Hemorrhage in Oral AntiCoagulant Treated Patients With Mild Traumatic Brain Injury
Lead Sponsor:
Bispebjerg Hospital
Conditions:
Head Trauma
Head Injury
Eligibility:
All Genders
65+ years
Brief Summary
As a low quality, weak recommendation, it is part of the Scandinavian guidelines for initial management of minimal, mild and moderate head injuries in adults, that patient with a GCS of 14-15 and anti...
Detailed Description
As a low quality, weak recommendation, it is part of the Scandinavian guidelines for initial management of minimal, mild and moderate head injuries in adults, that patient with a GCS of 14-15 and anti...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 10 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 31 2027
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT07195760
Start Date
February 10 2023
End Date
January 31 2027
Last Update
September 29 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Bispebjerg and Frederiksberg Hospital
Copenhagen NV, Denmark, 2400