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Clinical Trials in Denmark / NCT07195760
Active, not recruiting Observational

Delayed IntraCranial Hemorrhage in Oral AntiCoagulant Treated Patients With Mild Traumatic Brain Injury

NCT07195760 · tracked via the Priya Life Science Denmark tracker
Phase
Observational
Started
2023-02-10
Last updated
2025-09-29

Condition(s) studied

Head TraumaHead InjuryDeliriumThrombosis

Study 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 anticoagulation therapy and a normal CT should be admitted for observation for at least 24 hours. No data are available on the adverse events related to the observational 24-hour admission. The aim was to evaluate the risk of post-CT hemorrhage as well as the risk of complications to an admission (e.g. deleria, thrombosis due to pause of antithrombotic medications.

Eligibility

Sex
ALL
Min age
65 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Bispebjerg and Frederiksberg Hospital Copenhagen NV Denmark

More Bispebjerg Hospital trials in Denmark

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07195760 on ClinicalTrials.gov ↗ ← All trials in Denmark