Chronic Subdural Hematoma and Aspirin

N/ACompletedNCT03120182

University Hospital, Basel, Switzerland150 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

150

Conditions

Chronic Subdural Hematoma

Interventions

Acetylsalicylic acidDRUG

Patients will receive acetylsalicylic acid 100mg daily for 12 days after randomization

Placebo Oral TabletDRUG

Patients will receive placebo medication 100mg daily for 12 days after randomization

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Neurosurgery

Basel, Switzerland

Outcomes

Primary Outcomes

Revision surgery due to a recurrent subdural hematoma

Recurrence of chronic subdural hematoma requiring revision surgery (burr-hole drainage)

Time frame: 6 months

Secondary Outcomes

Myocardial infarction

(STEMI/non-STEMI)

Time frame: 6 months

Stroke

cerebral stroke

Time frame: 6 months

Peripheral arterial occlusion

occlusion of a peripheral artery

Time frame: 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)

Time frame: 6 months

Intraoperative blood loss

blood loss recorded during surgery

Time frame: on the operation day (up to 1 day)

Amount of blood/ fluid collected in the drain

Time frame: up to 2 days, at removal of the drainage

Postoperative anemia

hemoglobin\<80mg/L

Time frame: up to 7 days

Operation time

Data from ClinicalTrials.gov

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