Head TraumadICH-OACNCT07195760
Delayed IntraCranial Hemorrhage in Oral AntiCoagulant Treated Patients With Mild Traumatic Brain Injury
An observational study of Head Trauma and Head Injury, run by Bispebjerg Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Head Trauma, Head Injury, Delirium
- Type of treatment
- Pill or oral medicine
- How many people
- 600 participants
- Where
- 1 siteDenmark
- Study dates
- 10 Feb 2023to 31 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Delayed IntraCranial Hemorrhage in Oral AntiCoagulant Treated Patients With Mild Traumatic Brain Injury (the dICH-OAC 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. 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.
Read the 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
- Keywords
- Oral anticoagulants, NOAC, DOAC, Vitamin K antagonist
- Medical subject headings
- Craniocerebral Trauma, Delirium, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delayed Intracranial hemorrhage within 24 hours
Hemorrhage found after initial CT scan but within 24 hours of trauma
Measured: 24 hours
Delayed Intracranial hemorrhage within 4 weeks
Hemorrhage found after initial CT scan but within 4 weeks of trauma
Measured: 4 weeks
Thrombotic events
Arterial or venous thrombotic events experienced within one week of trauma
Measured: 1 week
Deliria
Description of deliria during admission for initial head trauma
Measured: During admission = up to 1 week after admission
Other injuries with a competing need for admission at another department
Measured: admission = up to 1 week after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start10 Feb 2023
- Primary completion31 Jan 2024
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanne Christensen, Bispebjerg Hospital
- Investigators
- Hanne Christensen, MD, PhD, DMSci, Principal investigator, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07195760
- Sponsor's protocol ID
- J-23036221
- Other IDs
- 2211770
- Acronym
- dICH-OAC
- Status last verified
- Sep 2025
- First submitted
- 29 Aug 2023
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Aggregated, summary data are to be shared. However, individual participant data will only be made available as according to local law.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delayed IntraCranial Hemorrhage in Oral AntiCoagulant Treated Patients With Mild Traumatic Brain Injury (the dICH-OAC Study)
- ClinicalTrials.gov ID
- NCT07195760
- Acronym / sponsor ID
- dICH-OAC / J-23036221
- Conditions
- Head Trauma, Head Injury, Delirium, Thrombosis
- Keywords
- Oral anticoagulants, NOAC, DOAC, Vitamin K antagonist
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- 10 Feb 2023 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 29 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- Other reasons for observation despite normal CT, based on the Scandinavian guidelines for initial management of minimal, mild and moderate head injuries in adults:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Delayed Intracranial hemorrhage within 24 hours
Time frame: 24 hours
Hemorrhage found after initial CT scan but within 24 hours of trauma
Delayed Intracranial hemorrhage within 4 weeks
Time frame: 4 weeks
Hemorrhage found after initial CT scan but within 4 weeks of trauma
Thrombotic events
Time frame: 1 week
Arterial or venous thrombotic events experienced within one week of trauma
Deliria
Time frame: During admission = up to 1 week after admission
Description of deliria during admission for initial head trauma
Other injuries with a competing need for admission at another department
Time frame: admission = up to 1 week after admission
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- Individual participant dataSharing planned: No. Aggregated, summary data are to be shared. However, individual participant data will only be made available as according to local law.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hanne Christensen, MD, PhD, DMSci principal investigator
Bispebjerg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head Trauma and Head Injury, run by Bispebjerg Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delayed Intracranial hemorrhage within 24 hours (time frame: 24 hours). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.