An interventional study of Direct Acting Oral Anticoagulant starting at Day 30 and Direct Acting Oral Anticoagulant starting at Day 90 in Subdural Hematoma and Atrial Fibrillation, sponsored by Sunnybrook Health Sciences Centre. Terminated at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-04.
Sponsored by Sunnybrook Health Sciences Centre · Not applicable, Interventional, and Treatment
Subdural hematoma (SDH) is a common disorder that typically results from head trauma and has increased in prevalence in recent decades. Acute subdural hematomas (aSDH) are found in up to one-third of patients with severe traumatic brain injury and are associated with an unfavorable outcome in the majority of cases. Chronic subdural hematomas (cSDH) commonly occur in the elderly population which has highest risk for developing cSDH with or without minor head injuries. The combination of the aging population, higher incidence of disease in progressively older patients, and high morbidity and mortality renders SDH a growing problem within Canada with significant health-systems burden. SDH commonly recurs even after successful surgical drainage. Atrial fibrillation (AF) is one of the most common medical comorbidities in patients with cSDH, especially in the elderly, with an expected doubling of its prevalence by the year 2030. Patients with AF are at recognized risk for stroke, so anticoagulation is indicated for almost all patients. Anticoagulation is held prior to SDH drainage to minimize the risk of intraoperative and early postoperative bleeding. After surgery, the risk of SDH recurrence must be balanced against the risk of thromboembolic events such as stroke when deciding the timing of resuming anticoagulation. Currently the decision on when to restart anticoagulation after SDH is made by clinicians on an individual patient basis without any high-quality evidence to guide this decision. The two most common approaches are: 1) early resumption of anticoagulation after 30 days of diagnosis or surgery; and 2) delayed resumption of anticoagulation after 90 days of diagnosis or surgery. However, which of these approaches leads to the best functional outcomes for patients is unclear. Our pilot RCT will test the feasibility of comparing these 2 approaches in a larger multicenter RCT.
44 studies on the registry are indexed under Hematoma, Subdural; 15 are open to participants now.
This study's enrollment of 1 is below the median of 105 across 30 interventional studies indexed under Hematoma, Subdural.
Browse Hematoma, Subdural studies →Sunnybrook Health Sciences Centre is the lead sponsor of 584 studies on the registry; 135 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The standard of care DOAC at appropriate standard dose assigned by the MRP will start at day 30 +/- 7 after diagnosis of acute or chronic subdural hematoma.
Drug: Direct Acting Oral Anticoagulant starting at Day 30
The standard of care DOAC at appropriate standard dose assigned by the MRP will start at day 90 +/- 14 after diagnosis of acute or chronic subdural hematoma.
Drug: Direct Acting Oral Anticoagulant starting at Day 90
Dabigatran, Rivaroxaban, Apixaban or Edoxaban at standard dose as recommended by the MRP
Dabigatran, Rivaroxaban, Apixaban or Edoxaban at standard dose as recommended by the MRP
Recruitment rate
The number of participants enrolled for each participating institution, measured as the rate of consent for patients meeting eligibility criteria in one year per institution. Reasons for non-enrollment of eligible patients will be recorded
Time frame: 1 year
Implementation of study protocol
The proportion of enrolled participants who have completed follow-up measures at 90 days with complete recording of the functional outcome degree of disability
Time frame: Study completion ~2.5 years
Functional outcome - Degree of disability
Level of disability measured by the modified Rankin Scale (mRS). The mRS is a core instrument used for measuring the degree of disability or dependence in activities of daily living that is sensitive to thromboembolic and hemorrhagic complications. It is a clinician-reported measure and widely applied for evaluating stroke patient outcomes. It is a 7-level ordered categorical scale with scores ranging from 0 (no symptoms/disability) to 6 (death). The analysis will be categorized as favourable outcome (scores 0-3) versus unfavourable outcome (scores 4-6)
Time frame: 90 days
Functional outcome - Degree of disability
Level of disability measured by the modified Rankin Scale (mRS). The mRS is a core instrument used for measuring the degree of disability or dependence in activities of daily living that is sensitive to thromboembolic and hemorrhagic complications. It is a clinician-reported measure and widely applied for evaluating stroke patient outcomes. It is a 7-level ordered categorical scale with scores ranging from 0 (no symptoms/disability) to 6 (death). The analysis will be categorized as favourable outcome (scores 0-3) versus unfavourable outcome (scores 4-6)
Time frame: 180 days
Functional outcome - Stroke-related neurologic deficit
Measured using the National Institute of Health Stroke Scale (NIHSS) which is a 15-item impairment scale. It groups scores into categories based on severity, ranging from mild to very severe, with a higher score indicating a greater degree of impairment
Time frame: 90 days
Functional outcome - Stroke-related neurologic deficit
Measured using the National Institute of Health Stroke Scale (NIHSS) which is a 15-item impairment scale. It groups scores into categories based on severity, ranging from mild to very severe, with a higher score indicating a greater degree of impairment
Time frame: 180 days
Incidence of intracranial hemorrhage
The composite outcome of clinically-important intracranial hemorrhage defined by: 1) any increase in volume of blood in the CT of at least 33%; 2) need for surgical evacuation of SDH or repeat surgical evacuation; 3) death directly related to enlarging SDH or new parenchymal bleed; 4) symptomatic bleeding in a critical non-intracranial region
Time frame: Continuous, baseline to 180 days
Incidence of thromboembolic events
Composite outcome of clinically-important thromboembolic events defined as any of: 1) symptomatic TIA; 2) symptomatic objectively-confirmed ischemic stroke; 3) symptomatic, objectively-confirmed non-CNS systemic embolism; 4) objectively proven VTE; 5) all death directly or indirectly caused by a thrombotic event
Time frame: Continuous, baseline to 180 days
This study is terminated, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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