Chronic Subdural Hematoma and Aspirin (SECA)

• ClinicalTrials.gov Identifier: NCT03120182
• Recruitment Status: Unknown
• First Posted: April 19, 2017
• Last Update Posted: June 26, 2020
• Sponsor: University Hospital, Basel, Switzerland
• Information provided by (Responsible Party): University Hospital, Basel, Switzerland

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	Not Applicable

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 (Clinical Trial)
• Estimated Enrollment: 142 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: randomized, 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: February 19, 2018
• Estimated Primary Completion Date: December 31, 2021
• Estimated Study Completion Date: December 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 Name: 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 Name: Placebo

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Myocardial infarction [ Time Frame: 6 months ]
   (STEMI/non-STEMI)
2. Stroke [ Time Frame: 6 months ]
   cerebral stroke
3. Peripheral arterial occlusion [ Time Frame: 6 months ]
   occlusion of a peripheral artery
4. Other bleeding events apart from recurrent chronic subdural hematoma managed operatively or conservatively [ Time Frame: 6 months ]
   acute subdural hematoma (aSDH), acute epidural hematoma (EDH), intraparenchymal bleeding)
5. Intraoperative blood loss [ Time Frame: on the operation day (up to 1 day) ]
   blood loss recorded during surgery
6. Amount of blood/ fluid collected in the drain [ Time Frame: up to 2 days, at removal of the drainage ]
   Amount of blood/ fluid collected in the drain
7. Postoperative anemia [ Time Frame: up to 7 days ]
   hemoglobin<80mg/L
8. Operation time [ Time Frame: during surgery ]
   Operation time
9. Hospitalization time [ Time Frame: an average of 7 days ]
   Hospitalization time
10. Intraoperative blood transfusion rate [ Time Frame: during surgery (e.g. up to 1 day) ]
    blood transfusion rate intraoperatively
11. Postoperative blood transfusion rate [ Time Frame: during hospitalization, an average of 7 days ]
    blood transfusion rate postoperatively
12. GCS Score [ Time Frame: 6 months ]
    Glasgow Coma Scale
13. mRS [ Time Frame: 6 months ]
    modified Rankin scale
14. GOS [ Time Frame: 6 months ]
    Glasgow Outcome Scale
15. Clinical outcome [ Time Frame: 6 months ]
    Markwalder Score

Eligibility Criteria

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

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

Contacts and Locations

Contacts

Contact: Maria Kamenova, MD; 00413287814; maria.kamenova@usb.ch

Contact: Jehuda Soleman, MD; jehuda.soleman@usb.ch

Locations

Switzerland

Department of Neurosurgery; Recruiting

Basel, Switzerland, 4053

Contact: Maria Kamenova, MD

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: University Hospital, Basel, Switzerland
• ClinicalTrials.gov Identifier: NCT03120182
• Other Study ID Numbers: SECA
• First Posted: April 19, 2017
• Last Update Posted: June 26, 2020
• Last Verified: June 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by University Hospital, Basel, Switzerland:

aspirin; bleeding risk; intracranial bleeding; burr-hole drainage; chronic subdural hematoma; anticoagulation

Additional relevant MeSH terms:

Hematoma, Subdural; Hematoma, Subdural, Chronic; Hematoma; Chronic Disease; Hemorrhage; Pathologic Processes; Intracranial Hemorrhage, Traumatic; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries; Disease Attributes; Aspirin; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Molecular Mechanisms of Pharmacological Action