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Trial record 63 of 252 for:    ASPIRIN AND low-dose aspirin

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

Tracking Information
First Submitted Date  ICMJE April 10, 2017
First Posted Date  ICMJE April 19, 2017
Last Update Posted Date June 27, 2019
Actual Study Start Date  ICMJE February 19, 2018
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 14, 2017)
Revision surgery due to a recurrent subdural hematoma [ Time Frame: 6 months ]
Recurrence of chronic subdural hematoma requiring revision surgery (burr-hole drainage)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03120182 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 14, 2017)
  • Myocardial infarction [ Time Frame: 6 months ]
    (STEMI/non-STEMI)
  • Stroke [ Time Frame: 6 months ]
    cerebral stroke
  • Peripheral arterial occlusion [ Time Frame: 6 months ]
    occlusion of a peripheral artery
  • 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)
  • Intraoperative blood loss [ Time Frame: on the operation day (up to 1 day) ]
    blood loss recorded during surgery
  • 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
  • Postoperative anemia [ Time Frame: up to 7 days ]
    hemoglobin<80mg/L
  • Operation time [ Time Frame: during surgery ]
    Operation time
  • Hospitalization time [ Time Frame: an average of 7 days ]
    Hospitalization time
  • Intraoperative blood transfusion rate [ Time Frame: during surgery (e.g. up to 1 day) ]
    blood transfusion rate intraoperatively
  • Postoperative blood transfusion rate [ Time Frame: during hospitalization, an average of 7 days ]
    blood transfusion rate postoperatively
  • GCS Score [ Time Frame: 6 months ]
    Glasgow Coma Scale
  • mRS [ Time Frame: 6 months ]
    modified Rankin scale
  • GOS [ Time Frame: 6 months ]
    Glasgow Outcome Scale
  • Clinical outcome [ Time Frame: 6 months ]
    Markwalder Score
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Chronic Subdural Hematoma and Aspirin
Official Title  ICMJE 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
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
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Chronic Subdural Hematoma
Intervention  ICMJE
  • Drug: Acetylsalicylic acid
    Patients will receive acetylsalicylic acid 100mg daily for 12 days after randomization
    Other Name: Aspirin
  • Drug: Placebo Oral Tablet
    Patients will receive placebo medication 100mg daily for 12 days after randomization
    Other Name: Placebo
Study Arms  ICMJE
  • 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
    Intervention: Drug: Acetylsalicylic acid
  • 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
    Intervention: Drug: Placebo Oral Tablet
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 14, 2017)
142
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2022
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Maria Kamenova, MD 00413287814 maria.kamenova@usb.ch
Contact: Jehuda Soleman, MD jehuda.soleman@usb.ch
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03120182
Other Study ID Numbers  ICMJE SECA
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University Hospital, Basel, Switzerland
Study Sponsor  ICMJE University Hospital, Basel, Switzerland
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account University Hospital, Basel, Switzerland
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP