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临床试验/NCT03120182
NCT03120182已完成不适用

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

University Hospital, Basel, Switzerland1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2018年2月19日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
150
试验地点
1
主要终点
Revision surgery due to a recurrent subdural hematoma

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

double blinded study

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing burr hole trepanation for cSDH who are under low-dose aspirin treatment ( Aspirin cardio 100mg once a day) for secondary prophylaxis

排除标准

  • 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

研究组 & 干预措施

Placebo Arm

Placebo Comparator

The patients will receive placebo oral tablets for 12 days whereas the normal ASA treatment will be resumed 12 days after randomization

干预措施: Placebo Oral Tablet (Drug)

Aspirin Arm

Active Comparator

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

干预措施: Acetylsalicylic acid (Drug)

结局指标

主要结局

Revision surgery due to a recurrent subdural hematoma

时间窗: 6 months

Recurrence of chronic subdural hematoma requiring revision surgery (burr-hole drainage)

次要结局

  • Stroke(6 months)
  • Peripheral arterial occlusion(6 months)
  • Myocardial infarction(6 months)
  • Intraoperative blood loss(on the operation day (up to 1 day))
  • Amount of blood/ fluid collected in the drain(up to 2 days, at removal of the drainage)
  • Postoperative anemia(up to 7 days)
  • Hospitalization time(an average of 7 days)
  • Operation time(during surgery)
  • Intraoperative blood transfusion rate(during surgery (e.g. up to 1 day))
  • Postoperative blood transfusion rate(during hospitalization, an average of 7 days)
  • Clinical outcome(6 months)
  • Other bleeding events apart from recurrent chronic subdural hematoma managed operatively or conservatively(6 months)
  • GCS Score(6 months)
  • mRS(6 months)
  • GOS(6 months)

研究者

发起方
University Hospital, Basel, Switzerland
申办方类型
Other
责任方
Sponsor

研究点 (1)

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