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Active, Not Recruiting

NCT Number: NCT07195760

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Delayed Intracranial hemorrhage within 24 hours

    Time frame: 24 hours

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

  2. Delayed Intracranial hemorrhage within 4 weeks

    Time frame: 4 weeks

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

  3. Thrombotic events

    Time frame: 1 week

    Arterial or venous thrombotic events experienced within one week of trauma

  4. Deliria

    Time frame: During admission = up to 1 week after admission

    Description of deliria during admission for initial head trauma

  5. Other injuries with a competing need for admission at another department

    Time frame: admission = up to 1 week after admission

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Registry information

Official study title

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

Acronym: dICH-OAC

Important dates

Study start
2023
Primary completion
2024
Study completion
2027
First posted
Sep 29, 2025
Registry last updated
Sep 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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