Chronic Subdural Hematoma and Aspirin (SECA)
Primary Purpose
Chronic Subdural Hematoma
Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Acetylsalicylic acid
Placebo Oral Tablet
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Subdural Hematoma focused on measuring aspirin, bleeding risk, intracranial bleeding, burr-hole drainage, chronic subdural hematoma, anticoagulation
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing burr hole trepanation for cSDH who are under low-dose aspirin treatment ( Aspirin cardio 100mg once a day) for secondary prophylaxis
Exclusion Criteria:
- Patients under the age of 18years
- A recent (30 days before randomization) major cardiac event (i.e. unstable angina, myocardial infarction, or coronary revascularization)
- A recent (30 days before randomization) active bleeding event.
- Patient with known bleeding disorder (e.g. hemophilia)
- No informed consent
Sites / Locations
- Department of NeurosurgeryRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Aspirin Arm
Placebo Arm
Arm Description
The patients will receive acetylsalicylic acid (100mg once a day, orally) for 12 days whereas the normal ASA treatment will be resumed 12 days after randomization
The patients will receive placebo oral tablets for 12 days whereas the normal ASA treatment will be resumed 12 days after randomization
Outcomes
Primary Outcome Measures
Revision surgery due to a recurrent subdural hematoma
Recurrence of chronic subdural hematoma requiring revision surgery (burr-hole drainage)
Secondary Outcome Measures
Myocardial infarction
(STEMI/non-STEMI)
Stroke
cerebral stroke
Peripheral arterial occlusion
occlusion of a peripheral artery
Other bleeding events apart from recurrent chronic subdural hematoma managed operatively or conservatively
acute subdural hematoma (aSDH), acute epidural hematoma (EDH), intraparenchymal bleeding)
Intraoperative blood loss
blood loss recorded during surgery
Amount of blood/ fluid collected in the drain
Amount of blood/ fluid collected in the drain
Postoperative anemia
hemoglobin<80mg/L
Operation time
Operation time
Hospitalization time
Hospitalization time
Intraoperative blood transfusion rate
blood transfusion rate intraoperatively
Postoperative blood transfusion rate
blood transfusion rate postoperatively
GCS Score
Glasgow Coma Scale
mRS
modified Rankin scale
GOS
Glasgow Outcome Scale
Clinical outcome
Markwalder Score
Full Information
NCT ID
NCT03120182
First Posted
April 10, 2017
Last Updated
June 25, 2020
Sponsor
University Hospital, Basel, Switzerland
1. Study Identification
Unique Protocol Identification Number
NCT03120182
Brief Title
Chronic Subdural Hematoma and Aspirin
Acronym
SECA
Official Title
Impact of Perioperative Maintenance or Interruption of Low-dose Aspirin on Recurrence Rate and Thrombotic Events After Burr-hole Drainage of Chronic Subdural Hematoma: a Randomized, Placebo Controlled, Double Blinded Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 19, 2018 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this randomized, blinded, placebo controlled clinical study is to compare the peri- and postoperative bleeding and cardiovascular complication rates of patients undergoing burr-hole trepanation for chronic subdural hematoma with and without discontinuation of low-dose aspirin
Detailed Description
Chronic subdural hematoma (cSDH) is one of the most common neurosurgical conditions. Its significantly higher prevalence among patients older than 65 (69%) versus younger (31%) explains why 41% of the patients are taking blood thinners. Antiplatelet therapy in patients with chronic subdural hematoma (cSDH) presents significant neurosurgical challenges. Studies investigating the effect of acetylsalicylic acid (ASA) in cranial neurosurgery are sparse and mostly based on case reports. Given the lack of guidelines regarding perioperative management with antiplatelet therapy, it is difficult to balance the patient's increased cardiovascular risk and prevalence of cSDH. The aim of our randomized, blinded, placebo controlled clinical study is to compare the peri- and postoperative bleeding and cardiovascular complication rates of patients undergoing burr-hole trepanation for cSDH with and without discontinuation of low-dose ASA. We will include patients receiving low-dose ASA as secondary prophylaxis for various reasons (e.g. coronary artery disease (CAD), cerebrovascular disease, etc.) and will randomize them either to a Placebo- or Aspirin-arm. The patients will receive placebo or ASA for 12 days whereas the normal ASA treatment will be resumed 12 days after randomization. Our study primarily seeks to evaluate the risk of recurrence after burr-hole trepanation for cSDH under low-dose ASA treatment compared to placebo treatment. Secondary objectives are to assess the rate of thrombotic events, perioperative blood loss, postoperative anemia, intra- and postoperative blood transfusion rate, and clinical outcome (mRS, GOS, Markwalder score). The study will be performed in cooperation with the Department of Cardiology of the University Hospital of Basel.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Subdural Hematoma
Keywords
aspirin, bleeding risk, intracranial bleeding, burr-hole drainage, chronic subdural hematoma, anticoagulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized, placebo controlled, double blinded study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
double blinded study
Allocation
Randomized
Enrollment
142 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Aspirin Arm
Arm Type
Active Comparator
Arm Description
The patients will receive acetylsalicylic acid (100mg once a day, orally) for 12 days whereas the normal ASA treatment will be resumed 12 days after randomization
Arm Title
Placebo Arm
Arm Type
Placebo Comparator
Arm Description
The patients will receive placebo oral tablets for 12 days whereas the normal ASA treatment will be resumed 12 days after randomization
Intervention Type
Drug
Intervention Name(s)
Acetylsalicylic acid
Other Intervention Name(s)
Aspirin
Intervention Description
Patients will receive acetylsalicylic acid 100mg daily for 12 days after randomization
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Tablet
Other Intervention Name(s)
Placebo
Intervention Description
Patients will receive placebo medication 100mg daily for 12 days after randomization
Primary Outcome Measure Information:
Title
Revision surgery due to a recurrent subdural hematoma
Description
Recurrence of chronic subdural hematoma requiring revision surgery (burr-hole drainage)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Myocardial infarction
Description
(STEMI/non-STEMI)
Time Frame
6 months
Title
Stroke
Description
cerebral stroke
Time Frame
6 months
Title
Peripheral arterial occlusion
Description
occlusion of a peripheral artery
Time Frame
6 months
Title
Other bleeding events apart from recurrent chronic subdural hematoma managed operatively or conservatively
Description
acute subdural hematoma (aSDH), acute epidural hematoma (EDH), intraparenchymal bleeding)
Time Frame
6 months
Title
Intraoperative blood loss
Description
blood loss recorded during surgery
Time Frame
on the operation day (up to 1 day)
Title
Amount of blood/ fluid collected in the drain
Description
Amount of blood/ fluid collected in the drain
Time Frame
up to 2 days, at removal of the drainage
Title
Postoperative anemia
Description
hemoglobin<80mg/L
Time Frame
up to 7 days
Title
Operation time
Description
Operation time
Time Frame
during surgery
Title
Hospitalization time
Description
Hospitalization time
Time Frame
an average of 7 days
Title
Intraoperative blood transfusion rate
Description
blood transfusion rate intraoperatively
Time Frame
during surgery (e.g. up to 1 day)
Title
Postoperative blood transfusion rate
Description
blood transfusion rate postoperatively
Time Frame
during hospitalization, an average of 7 days
Title
GCS Score
Description
Glasgow Coma Scale
Time Frame
6 months
Title
mRS
Description
modified Rankin scale
Time Frame
6 months
Title
GOS
Description
Glasgow Outcome Scale
Time Frame
6 months
Title
Clinical outcome
Description
Markwalder Score
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients undergoing burr hole trepanation for cSDH who are under low-dose aspirin treatment ( Aspirin cardio 100mg once a day) for secondary prophylaxis
Exclusion Criteria:
Patients under the age of 18years
A recent (30 days before randomization) major cardiac event (i.e. unstable angina, myocardial infarction, or coronary revascularization)
A recent (30 days before randomization) active bleeding event.
Patient with known bleeding disorder (e.g. hemophilia)
No informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Kamenova, MD
Phone
00413287814
Email
maria.kamenova@usb.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Jehuda Soleman, MD
Email
jehuda.soleman@usb.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luigi Mariani, Prof, MD
Organizational Affiliation
Department of Neurosurgery, University Hospital Basel
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Maria Kamenova, MD
Organizational Affiliation
Department of Neurosurgery, University Hospital Basel
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jehuda Soleman, MD
Organizational Affiliation
Department of Neurosurgery, University Hospital Basel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neurosurgery
City
Basel
ZIP/Postal Code
4053
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Kamenova, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30665464
Citation
Kamenova M, Mueller C, Coslovsky M, Guzman R, Mariani L, Soleman J. Low-dose aspirin and burr-hole drainage of chronic subdural hematoma: study protocol for a randomized controlled study. Trials. 2019 Jan 21;20(1):70. doi: 10.1186/s13063-018-3064-y.
Results Reference
derived
Learn more about this trial
Chronic Subdural Hematoma and Aspirin
We'll reach out to this number within 24 hrs