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

Primary Purpose

Subdural Hematoma, Atrial Fibrillation

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Direct Acting Oral Anticoagulant starting at Day 30
Direct Acting Oral Anticoagulant starting at Day 90
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subdural Hematoma focused on measuring Direct-acting Oral Anticoagulants

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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. >35 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

Sites / Locations

  • Sunnybrook Health Sciences CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Early resumption of anticoagulation

Delayed resumption of anticoagulation

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Functional outcome - Degree of disability
Level of disability measured by the modified Rankin Scale (mRS). The mRS is a core instrument used for measuring the degree of disability or dependence in activities of daily living that is sensitive to thromboembolic and hemorrhagic complications. It is a clinician-reported measure and widely applied for evaluating stroke patient outcomes. It is a 7-level ordered categorical scale with scores ranging from 0 (no symptoms/disability) to 6 (death). The analysis will be categorized as favourable outcome (scores 0-3) versus unfavourable outcome (scores 4-6)
Functional outcome - Degree of disability
Level of disability measured by the modified Rankin Scale (mRS). The mRS is a core instrument used for measuring the degree of disability or dependence in activities of daily living that is sensitive to thromboembolic and hemorrhagic complications. It is a clinician-reported measure and widely applied for evaluating stroke patient outcomes. It is a 7-level ordered categorical scale with scores ranging from 0 (no symptoms/disability) to 6 (death). The analysis will be categorized as favourable outcome (scores 0-3) versus unfavourable outcome (scores 4-6)
Functional outcome - Stroke-related neurologic deficit
Measured using the National Institute of Health Stroke Scale (NIHSS) which is a 15-item impairment scale. It groups scores into categories based on severity, ranging from mild to very severe, with a higher score indicating a greater degree of impairment
Functional outcome - Stroke-related neurologic deficit
Measured using the National Institute of Health Stroke Scale (NIHSS) which is a 15-item impairment scale. It groups scores into categories based on severity, ranging from mild to very severe, with a higher score indicating a greater degree of impairment
Incidence of intracranial hemorrhage
The composite outcome of clinically-important intracranial hemorrhage defined by: 1) any increase in volume of blood in the CT of at least 33%; 2) need for surgical evacuation of SDH or repeat surgical evacuation; 3) death directly related to enlarging SDH or new parenchymal bleed; 4) symptomatic bleeding in a critical non-intracranial region
Incidence of thromboembolic events
Composite outcome of clinically-important thromboembolic events defined as any of: 1) symptomatic TIA; 2) symptomatic objectively-confirmed ischemic stroke; 3) symptomatic, objectively-confirmed non-CNS systemic embolism; 4) objectively proven VTE; 5) all death directly or indirectly caused by a thrombotic event

Full Information

First Posted
July 21, 2022
Last Updated
November 28, 2022
Sponsor
Sunnybrook Health Sciences Centre
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1. Study Identification

Unique Protocol Identification Number
NCT05472766
Brief Title
Anticoagulation Therapy Timing in Atrial Fibrillation After Acute and Chronic Subdural Hematoma
Acronym
ATTAACH
Official Title
Pilot Randomized Controlled Trial of Anticoagulation Therapy Timing in Atrial Fibrillation After Acute and Chronic Subdural Hematoma (ATTAACH)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 24, 2022 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunnybrook Health Sciences Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subdural Hematoma, Atrial Fibrillation
Keywords
Direct-acting Oral Anticoagulants

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Early resumption of anticoagulation
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Delayed resumption of anticoagulation
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Direct Acting Oral Anticoagulant starting at Day 30
Intervention Description
Dabigatran, Rivaroxaban, Apixaban or Edoxaban at standard dose as recommended by the MRP
Intervention Type
Drug
Intervention Name(s)
Direct Acting Oral Anticoagulant starting at Day 90
Intervention Description
Dabigatran, Rivaroxaban, Apixaban or Edoxaban at standard dose as recommended by the MRP
Primary Outcome Measure Information:
Title
Recruitment rate
Description
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
Time Frame
1 year
Title
Implementation of study protocol
Description
The proportion of enrolled participants who have completed follow-up measures at 90 days with complete recording of the functional outcome degree of disability
Time Frame
Study completion ~2.5 years
Secondary Outcome Measure Information:
Title
Functional outcome - Degree of disability
Description
Level of disability measured by the modified Rankin Scale (mRS). The mRS is a core instrument used for measuring the degree of disability or dependence in activities of daily living that is sensitive to thromboembolic and hemorrhagic complications. It is a clinician-reported measure and widely applied for evaluating stroke patient outcomes. It is a 7-level ordered categorical scale with scores ranging from 0 (no symptoms/disability) to 6 (death). The analysis will be categorized as favourable outcome (scores 0-3) versus unfavourable outcome (scores 4-6)
Time Frame
90 days
Title
Functional outcome - Degree of disability
Description
Level of disability measured by the modified Rankin Scale (mRS). The mRS is a core instrument used for measuring the degree of disability or dependence in activities of daily living that is sensitive to thromboembolic and hemorrhagic complications. It is a clinician-reported measure and widely applied for evaluating stroke patient outcomes. It is a 7-level ordered categorical scale with scores ranging from 0 (no symptoms/disability) to 6 (death). The analysis will be categorized as favourable outcome (scores 0-3) versus unfavourable outcome (scores 4-6)
Time Frame
180 days
Title
Functional outcome - Stroke-related neurologic deficit
Description
Measured using the National Institute of Health Stroke Scale (NIHSS) which is a 15-item impairment scale. It groups scores into categories based on severity, ranging from mild to very severe, with a higher score indicating a greater degree of impairment
Time Frame
90 days
Title
Functional outcome - Stroke-related neurologic deficit
Description
Measured using the National Institute of Health Stroke Scale (NIHSS) which is a 15-item impairment scale. It groups scores into categories based on severity, ranging from mild to very severe, with a higher score indicating a greater degree of impairment
Time Frame
180 days
Title
Incidence of intracranial hemorrhage
Description
The composite outcome of clinically-important intracranial hemorrhage defined by: 1) any increase in volume of blood in the CT of at least 33%; 2) need for surgical evacuation of SDH or repeat surgical evacuation; 3) death directly related to enlarging SDH or new parenchymal bleed; 4) symptomatic bleeding in a critical non-intracranial region
Time Frame
Continuous, baseline to 180 days
Title
Incidence of thromboembolic events
Description
Composite outcome of clinically-important thromboembolic events defined as any of: 1) symptomatic TIA; 2) symptomatic objectively-confirmed ischemic stroke; 3) symptomatic, objectively-confirmed non-CNS systemic embolism; 4) objectively proven VTE; 5) all death directly or indirectly caused by a thrombotic event
Time Frame
Continuous, baseline to 180 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ≥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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Farhad Pirouzmand
Phone
(416) 480-6100
Ext
5263
Email
ATTAACH_Trial@sunnybrook.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Farhad Pirouzmand, MD, MSc
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Farhad Pirouzmand
Email
attaach_trial@sunnybrook.ca
First Name & Middle Initial & Last Name & Degree
Farhad Pirouzmand, MD, MSc

12. IPD Sharing Statement

Learn more about this trial

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

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