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

NCT05472766 | Terminated DMC

• 1 other identifier: 3998
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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

Keywords

Direct-acting Oral Anticoagulants

Outcome Measures

Primary Outcomes (2)

• 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

  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

  Study completion ~2.5 years

Secondary Outcomes (6)

• Functional outcome - Degree of disability

  90 days

• Functional outcome - Degree of disability

  180 days

• Functional outcome - Stroke-related neurologic deficit

  90 days

• Functional outcome - Stroke-related neurologic deficit

  180 days

• Incidence of intracranial hemorrhage

  Continuous, baseline to 180 days

Study Arms (2)

Early resumption of anticoagulation

ACTIVE COMPARATOR

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

Delayed resumption of anticoagulation

ACTIVE COMPARATOR

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

Interventions

Direct Acting Oral Anticoagulant starting at Day 30 DRUG

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

Early resumption of anticoagulation

Direct Acting Oral Anticoagulant starting at Day 90 DRUG

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

Delayed resumption of anticoagulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• aSDH requiring decompressive craniectomy
• Mechanical heart valve or moderate to severe mitral stenosis
• 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
• \>37 days has elapsed since initial diagnosis without recruitment into the trial
• Active gastroduodenal ulcer, urogenital or respiratory tract hemorrhage
• Known pregnancy or breastfeeding
• Indication for therapeutic anticoagulation other than AF
• Pre-randomization brain CT at 2-4 weeks after initial diagnosis or surgery date reveals significant recurrence requiring surgical drainage
• Known to be non-compliant with prior anticoagulant
• MRP decides to restart Warfarin (as opposed to DOACs) as prophylactic anticoagulant as part of standard therapy for the patient after cSDH or aSDH

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Related Publications (1)

• 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.

  PMID: 39438108 DERIVED

MeSH Terms

Conditions

Hematoma, Subdural; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Intracranial Hemorrhage, Traumatic; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Vascular Diseases; Cardiovascular Diseases; Hematoma; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries; Arrhythmias, Cardiac; Heart Diseases

Study Officials

• Farhad Pirouzmand, MD, MSc

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2022
• First Posted: July 25, 2022
• Study Start: November 24, 2022
• Primary Completion: March 22, 2024
• Study Completion: May 10, 2024
• Last Updated: June 4, 2024

Record last verified: 2022-11

Locations

CA (1)