Chronic Subdural Hematoma and Aspirin

Chronic Subdural Hematoma Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03120182
• Other study ID #: SECA
• Status: Completed
• Phase: N/A
• Start date: February 19, 2018
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2024
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Subdural Hematoma
• Hematoma
• Hematoma, Subdural, Chronic

Intervention

Drug:
• Acetylsalicylic acid
Patients will receive acetylsalicylic acid 100mg daily for 12 days after randomization
• Placebo Oral Tablet
Patients will receive placebo medication 100mg daily for 12 days after randomization

Locations

Country	Name	City	State
Switzerland	Department of Neurosurgery	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Revision surgery due to a recurrent subdural hematoma	Recurrence of chronic subdural hematoma requiring revision surgery (burr-hole drainage)	6 months
Secondary	Myocardial infarction	(STEMI/non-STEMI)	6 months
Secondary	Stroke	cerebral stroke	6 months
Secondary	Peripheral arterial occlusion	occlusion of a peripheral artery	6 months
Secondary	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
Secondary	Intraoperative blood loss	blood loss recorded during surgery	on the operation day (up to 1 day)
Secondary	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
Secondary	Postoperative anemia	hemoglobin<80mg/L	up to 7 days
Secondary	Operation time	Operation time	during surgery
Secondary	Hospitalization time	Hospitalization time	an average of 7 days
Secondary	Intraoperative blood transfusion rate	blood transfusion rate intraoperatively	during surgery (e.g. up to 1 day)
Secondary	Postoperative blood transfusion rate	blood transfusion rate postoperatively	during hospitalization, an average of 7 days
Secondary	GCS Score	Glasgow Coma Scale	6 months
Secondary	mRS	modified Rankin scale	6 months
Secondary	GOS	Glasgow Outcome Scale	6 months
Secondary	Clinical outcome	Markwalder Score	6 months