Restart TICrH: An Adaptive Randomized Trial of Time Intervals to Restart Direct Oral Anticoagulants after Traumatic Intracranial Hemorrhage
| Autor: | Simin Roward, Jo Wick, Todd W. Costantini, Truman J. Milling, Gregory Y.H. Lip, Dinesh Pal Mudaranthakam, Alexander Muddiman, Ben King, Adrienne N. Dula, Byron J. Gajewski, S. Claiborne Johnston, Steven Warach, Michelle A. Price |
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| Rok vydání: | 2021 |
| Předmět: |
Male
030506 rehabilitation medicine.medical_specialty Traumatic brain injury medicine.drug_class Administration Oral Hemorrhage Time-to-Treatment Head trauma law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial law medicine Humans Single-Blind Method Prospective Studies Aged Aged 80 and over business.industry Anticoagulant Anticoagulants Thrombosis Atrial fibrillation Original Articles Middle Aged medicine.disease Surgery Clinical trial Relative risk Female Neurology (clinical) 0305 other medical science business Intracranial Hemorrhages 030217 neurology & neurosurgery Follow-Up Studies |
| Zdroj: | J Neurotrauma |
| ISSN: | 1557-9042 0897-7151 |
| DOI: | 10.1089/neu.2020.7535 |
| Popis: | Anticoagulants prevent thrombosis and death in patients with atrial fibrillation and venous thromboembolism (VTE) but also increase bleeding risk. The benefit/risk ratio favors anticoagulation in most of these patients. However, some will have a bleeding complication, such as the common trip-and-fall brain injury in elderly patients that results in traumatic intracranial hemorrhage. Clinicians must then make the difficult decision about when to restart the anticoagulant. Restarting too early risks making the bleeding worse. Restarting too late risks thrombotic events such as ischemic stroke and VTE, the indications for anticoagulation in the first place. There are more data on restarting patients with spontaneous intracranial hemorrhage, which is very different than traumatic intracranial hemorrhage. Spontaneous intracranial hemorrhage increases the risk of rebleeding because intrinsic vascular changes are widespread and irreversible. In contrast, traumatic cases are caused by a blow to the head, usually an isolated event portending less future risk. Clinicians generally agree that anticoagulation should be restarted but disagree about when. This uncertainty leads to long restart delays causing a large, potentially preventable burden of strokes and VTE, which has been unaddressed because of the absence of high quality evidence. Restart Traumatic Intracranial Hemorrhage (the “r” distinguished intracranial from intracerebral) (TICrH) is a prospective randomized open label blinded end-point response-adaptive clinical trial that will evaluate the impact of delays to restarting direct oral anticoagulation (1, 2, or 4 weeks) on the composite of thrombotic events and bleeding in patients presenting after traumatic intracranial hemorrhage. |
| Databáze: | OpenAIRE |
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