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

Delayed IntraCranial Hemorrhage in Oral AntiCoagulant Treated Patients With Mild Traumatic Brain Injury (the dICH-OAC Study)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07195760
Acronym
dICH-OAC
Enrollment
600
Registered
2025-09-29
Start date
2023-02-10
Completion date
2027-01-31
Last updated
2025-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delirium, Head Injury, Head Trauma, Thrombosis

Keywords

Oral anticoagulants, NOAC, DOAC, Vitamin K antagonist

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.

Interventions

None listed

Sponsors

Bispebjerg Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Delayed Intracranial hemorrhage within 24 hours24 hoursHemorrhage found after initial CT scan but within 24 hours of trauma
Delayed Intracranial hemorrhage within 4 weeks4 weeksHemorrhage found after initial CT scan but within 4 weeks of trauma
Thrombotic events1 weekArterial or venous thrombotic events experienced within one week of trauma
DeliriaDuring admission = up to 1 week after admissionDescription of deliria during admission for initial head trauma
Other injuries with a competing need for admission at another departmentadmission = up to 1 week after admission

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026