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Anticoagulant

Anticoagulation Therapy Timing for Atrial Fibrillation After Subdural Hematoma (ATTAACH Trial)

N/A
Recruiting
Led By Farhad Pirouzmand, MD, MSc
Research Sponsored by Sunnybrook Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
≥18 years of age
Can have surgical drainage (either burr hole or craniotomy) for aSDH and cSDH
Timeline
Screening 3 weeks
Treatment Varies
Follow Up study completion ~2.5 years
Awards & highlights

ATTAACH Trial Summary

This trial will compare the outcomes of two different approaches to restarting anticoagulation in patients who have had surgery for subdural hematoma.

Who is the study for?
This trial is for adults with subdural hematoma (SDH), a type of brain bleed, who were on blood thinners for atrial fibrillation before their diagnosis. They must have had or be eligible for surgical drainage and not have conditions like severe heart valve issues, uncontrollable bleeding disorders, significant SDH recurrence needing surgery, or pregnancy.Check my eligibility
What is being tested?
The study compares two timings to restart anticoagulation therapy after SDH: one group will begin taking a direct oral anticoagulant at day 30 post-diagnosis/surgery, while the other starts at day 90. The goal is to find out which timing leads to better patient outcomes.See study design
What are the potential side effects?
Potential side effects from restarting anticoagulants include an increased risk of bleeding in various parts of the body such as the stomach or urinary tract and possibly leading to another brain hemorrhage.

ATTAACH Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I can undergo surgery for drainage of a subdural hematoma.
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I am on blood thinners for stroke prevention due to atrial fibrillation.
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I have a specific type of brain bleed diagnosed by a CT scan.

ATTAACH Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~study completion ~2.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and study completion ~2.5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Implementation of study protocol
Recruitment rate
Secondary outcome measures
Functional outcome - Degree of disability
Cerebrovascular accident
Incidence of intracranial hemorrhage
+1 more

ATTAACH Trial Design

2Treatment groups
Active Control
Group I: Early resumption of anticoagulationActive Control1 Intervention
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 II: Delayed resumption of anticoagulationActive Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor
654 Previous Clinical Trials
1,543,177 Total Patients Enrolled
Farhad Pirouzmand, MD, MScPrincipal InvestigatorSunnybrook Health Sciences Centre

Media Library

Direct Acting Oral Anticoagulant (Anticoagulant) Clinical Trial Eligibility Overview. Trial Name: NCT05472766 — N/A
Subdural Hematoma Research Study Groups: Early resumption of anticoagulation, Delayed resumption of anticoagulation
Subdural Hematoma Clinical Trial 2023: Direct Acting Oral Anticoagulant Highlights & Side Effects. Trial Name: NCT05472766 — N/A
Direct Acting Oral Anticoagulant (Anticoagulant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05472766 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still openings for enrolment in this investigation?

"Affirmative. The information on clinicaltrials.gov suggests that the study is currently in search of participants, with its initial posting occurring on November 24th 2022 and latest revision made a few days later. A total of 120 individuals need to be recruited from 1 medical centre."

Answered by AI

What are the research objectives of this investigation?

"Over the course of twelve months, primary efficacy endpoints include adherence to study protocol and secondary objectives include thromboembolic events (symptomatic TIA, ischemic stroke, systemic embolism), functional outcomes measured by NIHSS scale and modified Rankin Scale. The latter two measure neurological deficit severity and disability respectively; favourable outcome are ranked 0-3 on both scales while unfavourable ones range from 4-6."

Answered by AI

To what extent is the patient cohort involved in this investigation?

"Affirmative. The official details on clinicaltrials.gov suggest that this medical trial is currently recruiting participants, and the listing was initially posted on November 24th 2022 with a most recent update occurring four days later. There are 120 openings for individuals at one specific location."

Answered by AI
~40 spots leftby Dec 2024