Clinical trial NCT05472766: Anticoagulation Therapy Timing in Atrial Fibrillation After Acute and Chronic Subdural Hematoma
Official title: Pilot Randomized Controlled Trial of Anticoagulation Therapy Timing in Atrial Fibrillation After Acute and Chronic Subdural Hematoma (ATTAACH)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Subdural Hematoma
Atrial Fibrillation
Keywords: Direct-acting Oral Anticoagulants
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2022-07-25
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. ≥18 years of age
2. Any SDH, defined as either acute or encapsulated partially liquefied hematoma in the subdural space diagnosed on a CT scan
3. Can have surgical drainage (either burr hole or craniotomy) for aSDH and cSDH
4. On therapeutic anticoagulation (DOAC or warfarin) as standard of care therapy prior to presentation for stroke prophylaxis secondary to AF

Exclusion Criteria:

1. aSDH requiring decompressive craniectomy
2. Mechanical heart valve or moderate to severe mitral stenosis
3. Known chronic coagulopathy (elevated INR \>1.5 or PTT\>40s after anticoagulant reversal, thrombocytopenia with platelet count \<50x109/L) that is not amenable to reversal
4. \>37 days has elapsed since initial diagnosis without recruitment into the trial
5. Active gastroduodenal ulcer, urogenital or respiratory tract hemorrhage
6. Known pregnancy or breastfeeding
7. Indication for therapeutic anticoagulation other than AF
8. Pre-randomization brain CT at 2-4 weeks after initial diagnosis or surgery date reveals significant recurrence requiring surgical drainage
9. Known to be non-compliant with prior anticoagulant
10. MRP decides to restart Warfarin (as opposed to DOACs) as prophylactic anticoagulant as part of standard therapy for the patient after cSDH or aSDH

Primary outcomes:
measure: Recruitment rate
timeFrame: 1 year
measure: Implementation of study protocol
timeFrame: Study completion ~2.5 years
Secondary outcomes:
measure: Functional outcome - Degree of disability
timeFrame: 90 days
measure: Functional outcome - Degree of disability
timeFrame: 180 days
measure: Functional outcome - Stroke-related neurologic deficit
timeFrame: 90 days
measure: Functional outcome - Stroke-related neurologic deficit
timeFrame: 180 days
measure: Incidence of intracranial hemorrhage
timeFrame: Continuous, baseline to 180 days
measure: Incidence of thromboembolic events
timeFrame: Continuous, baseline to 180 days
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Farhad Pirouzmand, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: