SECA: Chronic Subdural Hematoma and Aspirin

Sponsor

University Hospital, Basel, Switzerland (Other)

Overall Status

Recruiting

CT.gov ID

NCT03120182

Collaborator

(none)

142

Enrollment

Location

Arms

58.3

Anticipated Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Subdural Hematoma	Drug: Acetylsalicylic acid Drug: Placebo Oral Tablet	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

142 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

randomized, placebo controlled, double blinded studyrandomized, placebo controlled, double blinded study

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

double blinded study

Primary Purpose:

Treatment

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

Actual Study Start Date :

Feb 19, 2018

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Aspirin Arm 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 Patients will receive acetylsalicylic acid 100mg daily for 12 days after randomization Other Names: Aspirin
Placebo Comparator: Placebo Arm 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 Patients will receive placebo medication 100mg daily for 12 days after randomization Other Names: Placebo

Arm

Intervention/Treatment

Active Comparator: Aspirin Arm

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

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

Other Names:

Aspirin

Placebo Comparator: Placebo Arm

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

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

Other Names:

Placebo

Outcome Measures

Primary Outcome Measures

Revision surgery due to a recurrent subdural hematoma [6 months]
Recurrence of chronic subdural hematoma requiring revision surgery (burr-hole drainage)

Secondary Outcome Measures

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)
Intraoperative blood loss [on the operation day (up to 1 day)]
blood loss recorded during surgery
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
Postoperative blood transfusion rate [during hospitalization, an average of 7 days]
blood transfusion rate postoperatively
GCS Score [6 months]
Glasgow Coma Scale
mRS [6 months]
modified Rankin scale
GOS [6 months]
Glasgow Outcome Scale
Clinical outcome [6 months]
Markwalder Score

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Neurosurgery	Basel		Switzerland	4053

Sponsors and Collaborators

University Hospital, Basel, Switzerland

Investigators

Study Chair: Luigi Mariani, Prof, MD, Department of Neurosurgery, University Hospital Basel
Principal Investigator: Maria Kamenova, MD, Department of Neurosurgery, University Hospital Basel
Principal Investigator: Jehuda Soleman, MD, Department of Neurosurgery, University Hospital Basel