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Chronic Subdural Hematoma and Aspirin (SECA)

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ClinicalTrials.gov Identifier: NCT03120182
Recruitment Status : Recruiting
First Posted : April 19, 2017
Last Update Posted : June 27, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

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.

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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

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

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




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



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03120182


Contacts
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Contact: Maria Kamenova, MD 00413287814 maria.kamenova@usb.ch
Contact: Jehuda Soleman, MD jehuda.soleman@usb.ch

Locations
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Switzerland
Department of Neurosurgery Recruiting
Basel, Switzerland, 4053
Contact: Maria Kamenova, MD         
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT03120182     History of Changes
Other Study ID Numbers: SECA
First Posted: April 19, 2017    Key Record Dates
Last Update Posted: June 27, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Aspirin
Hematoma, Subdural
Hematoma, Subdural, Chronic
Hematoma
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
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
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors