Chronic Subdural Hematoma and Aspirin (SECA)

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

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

Study Overview

• Status: Recruiting
• Conditions: Chronic Subdural Hematoma
• Intervention / Treatment: Drug: Acetylsalicylic acid; Drug: Placebo Oral Tablet

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 Type: Interventional
• Enrollment (Anticipated): 142
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maria Kamenova, MD; Phone Number: 00413287814; Email: maria.kamenova@usb.ch
• Study Contact Backup: Name: Jehuda Soleman, MD; Email: jehuda.soleman@usb.ch

Study Locations

• Switzerland
  • Basel, Switzerland, 4053
    • Recruiting
    • Department of Neurosurgery
    • Contact: Maria Kamenova, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Revision surgery due to a recurrent subdural hematoma	Recurrence of chronic subdural hematoma requiring revision surgery (burr-hole drainage)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Myocardial infarction	(STEMI/non-STEMI)	6 months
Stroke	cerebral stroke	6 months
Peripheral arterial occlusion	occlusion of a peripheral artery	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)	6 months
Intraoperative blood loss	blood loss recorded during surgery	on the operation day (up to 1 day)
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
Postoperative anemia	hemoglobin<80mg/L	up to 7 days
Operation time	Operation time	during surgery
Hospitalization time	Hospitalization time	an average of 7 days
Intraoperative blood transfusion rate	blood transfusion rate intraoperatively	during surgery (e.g. up to 1 day)
Postoperative blood transfusion rate	blood transfusion rate postoperatively	during hospitalization, an average of 7 days
GCS Score	Glasgow Coma Scale	6 months
mRS	modified Rankin scale	6 months
GOS	Glasgow Outcome Scale	6 months
Clinical outcome	Markwalder Score	6 months

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2018
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: April 10, 2017
• First Submitted That Met QC Criteria: April 14, 2017
• First Posted (Actual): April 19, 2017

Study Record Updates

• Last Update Posted (Actual): June 26, 2020
• Last Update Submitted That Met QC Criteria: June 25, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: anticoagulation; aspirin; intracranial bleeding; bleeding risk; chronic subdural hematoma; burr-hole drainage
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Hemorrhage; Craniocerebral Trauma; Trauma, Nervous System; Intracranial Hemorrhages; Intracranial Hemorrhage, Traumatic; Hematoma; Hematoma, Subdural; Hematoma, Subdural, Chronic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Aspirin
• Other Study ID Numbers: SECA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No