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Restart TICrH Alpha Pilot Protocol, Restarting DOACs After Traumatic Intracranial Hemorrhage

Anticoagulants; Increased Clinical Trial

Official title:
A Pilot Trial of Restarting Direct Oral Anticoagulants After Traumatic Intracranial Hemorrhage

Clinical Trial Summary

Randomized pilot trial of restarting DOACs at 1 week versus 4 weeks after traumatic intracranial hemorrhage

Clinical Trial Description

Restart TICrH two-center pilot trial will assign patients with anticoagulant-associated traumatic intracranial hemorrhage to restart anticoagulation at 1 week or 4 weeks. Entry into the trial is primarily driven pragmatically by clinician intent to restart any Direct Oral Anticoagulant (DOAC, i.e. apixaban, rivaroxaban, edoxaban, dabigatran. There is no head to head evidence of superiority of any drug) after anticoagulant-associated traumatic intracranial hemorrhage and equipoise concerning restart of anticoagulation at the specified time intervals. DOAC will be at label dose with label adjustments for creatinine clearance. DOAC will be at continuation dose, i.e. not initial therapy high doses in the setting of VTE. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04891861
Study type Interventional
Source University of Texas at Austin
Contact Truman J Milling, MD
Phone 5124969742
Email tmilling@ascension.org
Status Not yet recruiting
Phase Phase 3
Start date July 1, 2021
Completion date July 1, 2023
View Details
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