Subdural HematomaATTAACHNCT05472766
Anticoagulation Therapy Timing in Atrial Fibrillation After Acute and Chronic Subdural Hematoma
A study testing Direct Acting Oral Anticoagulant starting at Day 30 and Direct Acting Oral Anticoagulant starting at Day 90 in people with Subdural Hematoma and Atrial Fibrillation, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subdural Hematoma, Atrial Fibrillation
- What is being tested?
- Direct Acting Oral Anticoagulant starting at Day 30 and Direct Acting Oral Anticoagulant starting at Day 90
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteCanada
- Study dates
- 24 Nov 2022to 10 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Randomized Controlled Trial of Anticoagulation Therapy Timing in Atrial Fibrillation After Acute and Chronic Subdural Hematoma (ATTAACH)
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
- Being tested
- Direct Acting Oral Anticoagulant starting at Day 30, Direct Acting Oral Anticoagulant starting at Day 90
- Keywords
- Direct-acting Oral Anticoagulants
- Medical subject headings
- Hematoma, Subdural, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct Acting Oral Anticoagulant starting at Day 30Drug
Dabigatran, Rivaroxaban, Apixaban or Edoxaban at standard dose as recommended by the MRP
Direct Acting Oral Anticoagulant starting at Day 90Drug
Dabigatran, Rivaroxaban, Apixaban or Edoxaban at standard dose as recommended by the MRP
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Direct Acting Oral Anticoagulant starting at Day 90 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Study completion ~2.5 years
Secondary outcomes (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)
Measured: 90 days
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)
Measured: 180 days
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
Measured: 90 days
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
Measured: 180 days
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
Measured: Continuous, baseline to 180 days
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
Measured: Continuous, baseline to 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study start24 Nov 2022
- Primary completion22 Mar 2024
- Study completion10 May 2024
Why it stopped: Study terminated due to logistical challenges in conducting the trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Subdural HematomaStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Farhad Pirouzmand, MD, MSc, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05472766
- Sponsor's protocol ID
- 3998
- Acronym
- ATTAACH
- Status last verified
- Nov 2022
- First submitted
- 21 Jul 2022
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39438108
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Randomized Controlled Trial of Anticoagulation Therapy Timing in Atrial Fibrillation After Acute and Chronic Subdural Hematoma (ATTAACH)
- ClinicalTrials.gov ID
- NCT05472766
- Acronym / sponsor ID
- ATTAACH / 3998
- Conditions
- Subdural Hematoma, Atrial Fibrillation
- Keywords
- Direct-acting Oral Anticoagulants
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated due to logistical challenges in conducting the trial.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 24 Nov 2022 (actual)
- Primary completion
- 22 Mar 2024 (actual)
- Study completion
- 10 May 2024 (actual)
- First posted
- 25 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early resumption of anticoagulation | Active comparator | Drug: Direct Acting Oral Anticoagulant starting at Day 30The 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. |
| Delayed resumption of anticoagulation | Active comparator | Drug: Direct Acting Oral Anticoagulant starting at Day 90The 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Direct Acting Oral Anticoagulant starting at Day 30Dabigatran, Rivaroxaban, Apixaban or Edoxaban at standard dose as recommended by the MRP | Drug | Early resumption of anticoagulation |
| Direct Acting Oral Anticoagulant starting at Day 90Dabigatran, Rivaroxaban, Apixaban or Edoxaban at standard dose as recommended by the MRP | Drug | Delayed resumption of anticoagulation |
Primary outcome
Recruitment rate
Time frame: 1 year
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
Time frame: Study completion ~2.5 years
The proportion of enrolled participants who have completed follow-up measures at 90 days with complete recording of the functional outcome degree of disability
6 secondary outcomes
Functional outcome - Degree of disability
Time frame: 90 days
Functional outcome - Degree of disability
Time frame: 180 days
Functional outcome - Stroke-related neurologic deficit
Time frame: 90 days
Functional outcome - Stroke-related neurologic deficit
Time frame: 180 days
Incidence of intracranial hemorrhage
Time frame: Continuous, baseline to 180 days
Incidence of thromboembolic events
Time frame: Continuous, baseline to 180 days
Results and safety
The study was stopped early (reason given: Study terminated due to logistical challenges in conducting the trial.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Derived from this study: PubMed 39438108Mansouri 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Farhad Pirouzmand, MD, MSc principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Direct Acting Oral Anticoagulant starting at Day 30 and Direct Acting Oral Anticoagulant starting at Day 90 in people with Subdural Hematoma and Atrial Fibrillation, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study terminated due to logistical challenges in conducting the trial.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05472766, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024; AzTrials last refreshed its copy on 8 Nov 2026.