Clinical trial NCT03120182: Chronic Subdural Hematoma and Aspirin
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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Subdural Hematoma
Keywords: aspirin
bleeding risk
intracranial bleeding
burr-hole drainage
chronic subdural hematoma
anticoagulation
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2017-04-19
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, placebo controlled, double blinded study
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Revision surgery due to a recurrent subdural hematoma
timeFrame: 6 months
Secondary outcomes:
measure: Myocardial infarction
timeFrame: 6 months
measure: Stroke
timeFrame: 6 months
measure: Peripheral arterial occlusion
timeFrame: 6 months
measure: Other bleeding events apart from recurrent chronic subdural hematoma managed operatively or conservatively
timeFrame: 6 months
measure: Intraoperative blood loss
timeFrame: on the operation day (up to 1 day)
measure: Amount of blood/ fluid collected in the drain
timeFrame: up to 2 days, at removal of the drainage
measure: Postoperative anemia
timeFrame: up to 7 days
measure: Operation time
timeFrame: during surgery
measure: Hospitalization time
timeFrame: an average of 7 days
measure: Intraoperative blood transfusion rate
timeFrame: during surgery (e.g. up to 1 day)
measure: Postoperative blood transfusion rate
timeFrame: during hospitalization, an average of 7 days
measure: GCS Score
timeFrame: 6 months
measure: mRS
timeFrame: 6 months
measure: GOS
timeFrame: 6 months
measure: Clinical outcome
timeFrame: 6 months
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Department of Neurosurgery
Study officials:
affiliation: Department of Neurosurgery, University Hospital Basel
name: Luigi Mariani, Prof, MD
role: STUDY_CHAIR
affiliation: Department of Neurosurgery, University Hospital Basel
name: Maria Kamenova, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Neurosurgery, University Hospital Basel
name: Jehuda Soleman, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.