Delayed resumption of anticoagulation for Atrial Fibrillation

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Sunnybrook Health Sciences Centre, Toronto, Canada
Atrial Fibrillation+4 More
Direct Acting Oral Anticoagulant starting at Day 30 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions

  • Atrial Fibrillation
  • Subdural haematoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Atrial Fibrillation

Study Objectives

2 Primary · 6 Secondary · Reporting Duration: Study completion ~2.5 years

1 year
Recruitment rate
180 days
Functional outcome - Degree of disability
Functional outcome - Stroke-related neurologic deficit
Day 180
Effectiveness
Incidence of intracranial hemorrhage
Incidence of thromboembolic events
Safety outcome
Study completion ~2.5 years
Implementation of study protocol

Trial Safety

Safety Progress

1 of 3

Other trials for Atrial Fibrillation

Trial Design

2 Treatment Groups

Delayed resumption of anticoagulation
1 of 2
Early resumption of anticoagulation
1 of 2
Active Control

120 Total Participants · 2 Treatment Groups

Primary Treatment: Delayed resumption of anticoagulation · No Placebo Group · N/A

Delayed resumption of anticoagulation
Drug
ActiveComparator Group · 1 Intervention: Direct Acting Oral Anticoagulant starting at Day 90 · Intervention Types: Drug
Early resumption of anticoagulation
Drug
ActiveComparator Group · 1 Intervention: Direct Acting Oral Anticoagulant starting at Day 30 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: study completion ~2.5 years
Closest Location: Sunnybrook Health Sciences Centre · Toronto, Canada
Photo of sunnybrook health sciences centre  1Photo of sunnybrook health sciences centre  2Photo of sunnybrook health sciences centre  3
2007First Recorded Clinical Trial
23 TrialsResearching Atrial Fibrillation
422 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are at least 18 years old.
You have a subdural hematoma that is either acute or encapsulated partially liquefied.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.