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

NCT ID: NCT07195760

Last Updated: 2025-09-29

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-02-10
• Study Completion Date: 2027-01-31

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.

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 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.

Because of this, the investigators aim to evaluate the following outcomes in a cohort of consecutive patients aged 65 or above, admitted at the acute neurological department or emergency room of Bispebjerg Hospital in the Capital Region of Denmark from June 1st 2020 - May 31st 2022 following a mild or minimal head trauma with no intracranial hemorrhage on initial head CT and compare outcomes of patients pre-treated with oral anticoagulants to patients treated with platelet inhibitors and patients without antithrombotic treatment:

• Delayed intracranial hemorrhage within 24 hours and 4 weeks (incl. readmissions)
• Delayed diagnosis of intracranial hemorrhage
• Thrombotic events within 1 week of trauma
• Deliria during admission
• Other injuries with a competing need for admissions at other departments

The overall goal is to add to the evidence in the area, so that there can be sufficient evidence, to potentially update the recommendations in the Scandinavian Guideline for initial management of minimal, mild, and moderate head injuries in adults. This with the hope that the results will benefit not only the health care economy, but also the quality of patient care.

Conditions

Head Trauma; Head Injury; Delirium; Thrombosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Oral anticoagulated

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

No interventions assigned to this group

Platelet inhibited

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

No interventions assigned to this group

Not on antithrombotics

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

No interventions assigned to this group

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bispebjerg Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hanne Christensen

Professor, Consultant Neurologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hanne Christensen, MD, PhD, DMSci

Role: PRINCIPAL_INVESTIGATOR

Bispebjerg Hospital

Locations

Bispebjerg and Frederiksberg Hospital

Copenhagen NV, , Denmark

Countries

Denmark

Other Identifiers

2211770

Identifier Type: OTHER

Identifier Source: secondary_id

J-23036221

Identifier Type: -

Identifier Source: org_study_id