Clinical Trial: Chronic Subdural Hematoma and Aspirin

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

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 Summary: 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.
Sponsor: University Hospital, Basel, Switzerland

Current Primary Outcome: 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: Same as current

Current Secondary Outcome:

  • 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: Same as current

Information By: University Hospital, Basel, Switzerland

Dates:
Date Received: April 10, 2017
Date Started: January 1, 2018
Date Completion: December 31, 2022
Last Updated: April 14, 2017
Last Verified: April 2017