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| ID | Type | Description | Link |
|---|---|---|---|
| 2211770 | Other Identifier | Danish National Center for Ethics |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Hanne Christensen, MD, PhD, DMSci | Bispebjerg Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bispebjerg and Frederiksberg Hospital | Copenhagen NV | 2400 | Denmark |
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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| ID | Term |
|---|---|
| D006259 | Craniocerebral Trauma |
| D003693 | Delirium |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D020196 | Trauma, Nervous System |
| D009422 | Nervous System Diseases |
| D014947 | Wounds and Injuries |
| D003221 | Confusion |
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| D019954 |
| Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |