Chronic Subdural Hematoma and Aspirin

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Chronic Subdural Hematoma

Intervention / Treatment
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* Drug: Acetylsalicylic acid
* Drug: Placebo Oral Tablet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized, placebo controlled, double blinded study
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Aspirin Arm<br>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 | Drug: Acetylsalicylic acid<br>* Patients will receive acetylsalicylic acid 100mg daily for 12 days after randomization<br>* Other names: Aspirin;|
| Placebo Comparator: Placebo Arm<br>The patients will receive placebo oral tablets for 12 days whereas the normal ASA treatment will be resumed 12 days after randomization | Drug: Placebo Oral Tablet<br>* Patients will receive placebo medication 100mg daily for 12 days after randomization<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Revision surgery due to a recurrent subdural hematoma | Recurrence of chronic subdural hematoma requiring revision surgery (burr-hole drainage) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myocardial infarction | (STEMI/non-STEMI) | 6 months | 
| Stroke | cerebral stroke | 6 months | 
| Peripheral arterial occlusion | occlusion of a peripheral artery | 6 months | 
| Other bleeding events apart from recurrent chronic subdural hematoma managed operatively or conservatively | acute subdural hematoma (aSDH), acute epidural hematoma (EDH), intraparenchymal bleeding) | 6 months | 
| Intraoperative blood loss | blood loss recorded during surgery | on the operation day (up to 1 day) | 
| Amount of blood/ fluid collected in the drain | Amount of blood/ fluid collected in the drain | up to 2 days, at removal of the drainage | 
| Postoperative anemia | hemoglobin<80mg/L | up to 7 days | 
| Operation time | Operation time | during surgery | 
| Hospitalization time | Hospitalization time | an average of 7 days | 
| Intraoperative blood transfusion rate | blood transfusion rate intraoperatively | during surgery (e.g. up to 1 day) | 
| Postoperative blood transfusion rate | blood transfusion rate postoperatively | during hospitalization, an average of 7 days | 
| GCS Score | Glasgow Coma Scale | 6 months | 
| mRS | modified Rankin scale | 6 months | 
| GOS | Glasgow Outcome Scale | 6 months | 
| Clinical outcome | Markwalder Score | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aspirin, bleeding risk, intracranial bleeding, burr-hole drainage, chronic subdural hematoma, anticoagulation