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

NCT07195760 | Active Not Recruiting DMC

• 2 other identifiers: J-230362212211770
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Head Trauma; Head Injury; Delirium; Thrombosis

Keywords

Oral anticoagulants; NOAC; DOAC; Vitamin K antagonist

Outcome Measures

Primary Outcomes (5)

• Delayed Intracranial hemorrhage within 24 hours

  Hemorrhage found after initial CT scan but within 24 hours of trauma

  24 hours

• Delayed Intracranial hemorrhage within 4 weeks

  Hemorrhage found after initial CT scan but within 4 weeks of trauma

  4 weeks

• Thrombotic events

  Arterial or venous thrombotic events experienced within one week of trauma

  1 week

• Deliria

  Description of deliria during admission for initial head trauma

  During admission = up to 1 week after admission

• Other injuries with a competing need for admission at another department

  admission = up to 1 week after admission

Study Arms (3)

Oral anticoagulated

Patients admitted with mild head traume and oral anticoagulation treatment, having a CT performed.

Platelet inhibited

Patients admitted with mild head traume and antiplatelet treatment, having a CT performed.

Not on antithrombotics

Patients admitted with mild head trauma, not treated with antithrombotics, having a S100B performed.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The identification of patients for screening will follow the Scandinavian guideline algorithm. The first and second group will be patients in whom the procedure code for computer tomography (CT) of the cerebrum has been recorded and who had a prescription of either a platelet inhibitor or an oral anticoagulant (OAC) on admission. The prescription is transferred from the shared medicines cart to the local system by the admitting physician, with the only exception being if the prescription is immediately suspended on admission, which should only be the case if the patient already stopped taking the medication. The third group will be all the patients in whom a s100b test was performed.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bispebjerg Hospital: lead

Study Sites (1)

Bispebjerg and Frederiksberg Hospital

Copenhagen NV, 2400, Denmark

Location

MeSH Terms

Conditions

Craniocerebral Trauma; Delirium; Thrombosis

Condition Hierarchy (Ancestors)

Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Hanne Christensen, MD, PhD, DMSci

  Bispebjerg Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Consultant Neurologist

Study Record Dates

• First Submitted: August 29, 2023
• First Posted: September 29, 2025
• Study Start: February 10, 2023
• Primary Completion: January 31, 2024
• Study Completion (Estimated): January 31, 2027
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)