Bispebjerg and Frederiksberg Hospital
Copenhagen NV, 2400, Denmark
NCT Number: NCT07195760
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.
This study is active but is not currently recruiting participants.
65 year and older
All sexes
Observational
Copenhagen NV, 2400, Denmark
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 24 hours
Hemorrhage found after initial CT scan but within 24 hours of trauma
Time frame: 4 weeks
Hemorrhage found after initial CT scan but within 4 weeks of trauma
Time frame: 1 week
Arterial or venous thrombotic events experienced within one week of trauma
Time frame: During admission = up to 1 week after admission
Description of deliria during admission for initial head trauma
Time frame: admission = up to 1 week after admission
Bispebjerg Hospital
Other
Delayed IntraCranial Hemorrhage in Oral AntiCoagulant Treated Patients With Mild Traumatic Brain Injury (the dICH-OAC Study)
Acronym: dICH-OAC
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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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