Anticoagulation Therapy Timing in Atrial Fibrillation After Acute and Chronic Subdural Hematoma

NCT ID: NCT05472766

Last Updated: 2024-06-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-24
• Study Completion Date: 2024-05-10

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.

Conditions

Subdural Hematoma; Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Early resumption of anticoagulation

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.

Group Type: ACTIVE_COMPARATOR

Direct Acting Oral Anticoagulant starting at Day 30

Intervention Type: DRUG

Dabigatran, Rivaroxaban, Apixaban or Edoxaban at standard dose as recommended by the MRP

Delayed resumption of anticoagulation

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.

Group Type: ACTIVE_COMPARATOR

Direct Acting Oral Anticoagulant starting at Day 90

Intervention Type: DRUG

Dabigatran, Rivaroxaban, Apixaban or Edoxaban at standard dose as recommended by the MRP

Interventions

Direct Acting Oral Anticoagulant starting at Day 30

Dabigatran, Rivaroxaban, Apixaban or Edoxaban at standard dose as recommended by the MRP

Intervention Type: DRUG

Direct Acting Oral Anticoagulant starting at Day 90

Dabigatran, Rivaroxaban, Apixaban or Edoxaban at standard dose as recommended by the MRP

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Farhad Pirouzmand, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre

Locations

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Countries

Canada

References

Mansouri A, Nassiri F, Scales D, Pirouzmand F. Anticoagulation Therapy Timing in patients with Atrial Fibrillation after Acute and Chronic Subdural Haematoma (ATTAACH): a pilot randomised controlled trial. BMJ Open. 2024 Oct 22;14(10):e090224. doi: 10.1136/bmjopen-2024-090224.

Reference Type: DERIVED

PMID: 39438108 (View on PubMed)

Other Identifiers

3998

Identifier Type: -

Identifier Source: org_study_id