Chronic Subdural Hematoma
Conditions
Keywords
aspirin, bleeding risk, intracranial bleeding, burr-hole drainage, chronic subdural hematoma, anticoagulation
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.
Interventions
DRUGAcetylsalicylic acid
Patients will receive acetylsalicylic acid 100mg daily for 12 days after randomization
DRUGPlacebo Oral Tablet
Patients will receive placebo medication 100mg daily for 12 days after randomization
Sponsors
University Hospital, Basel, Switzerland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
double blinded study
Intervention model description
randomized, placebo controlled, double blinded study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Revision surgery due to a recurrent subdural hematoma | 6 months | Recurrence of chronic subdural hematoma requiring revision surgery (burr-hole drainage) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| mRS | 6 months | modified Rankin scale |
| GOS | 6 months | Glasgow Outcome Scale |
| Postoperative blood transfusion rate | during hospitalization, an average of 7 days | blood transfusion rate postoperatively |
| Myocardial infarction | 6 months | (STEMI/non-STEMI) |
| Stroke | 6 months | cerebral stroke |
| Peripheral arterial occlusion | 6 months | occlusion of a peripheral artery |
| Other bleeding events apart from recurrent chronic subdural hematoma managed operatively or conservatively | 6 months | acute subdural hematoma (aSDH), acute epidural hematoma (EDH), intraparenchymal bleeding) |
| GCS Score | 6 months | Glasgow Coma Scale |
| Amount of blood/ fluid collected in the drain | up to 2 days, at removal of the drainage | Amount of blood/ fluid collected in the drain |
| Postoperative anemia | up to 7 days | hemoglobin\<80mg/L |
| Operation time | during surgery | Operation time |
| Hospitalization time | an average of 7 days | Hospitalization time |
| Intraoperative blood transfusion rate | during surgery (e.g. up to 1 day) | blood transfusion rate intraoperatively |
| Clinical outcome | 6 months | Markwalder Score |
| Intraoperative blood loss | on the operation day (up to 1 day) | blood loss recorded during surgery |
Countries
Switzerland
Outcome results
None listed