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临床试验/NCT02391883
NCT02391883已完成不适用

Hip-Fracture Surgery on Patients in Clopidogrel Therapy

Hvidovre University Hospital0 个研究点目标入组 356 人开始时间: 2011年1月最近更新:
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
入组人数
356
主要终点
Surgical Blood Loss

研究概览

简要总结

Patients in Clopidogrel therapy alone or in combination with acetylsalicylic acid (Dual Antiplatelet Therapy (DAPT) presenting with a hip-fracture represent the surgeon with the dilemma of putting the patient at risk of a major blood loss during and after surgery, or putting the patient at risk of a thromboembolic event after surgery. The investigators hypothesize that the risk of a major blood loss in patients that are still under the effect of Clopidogrel or DAPT during or after hip-fracture surgery is relatively low. The investigators have conducted a retrospective observational study on hip-fracture patients to test this hypothesis.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • All patients operated with short intramedullary nail for hip-fractures, in the study period. (1st of Jan. 2011-31st of Dec. 2013)

排除标准

  • patients operated >24 hours after admission, patients in other forms of anticoagulation medication except acetylsalicylic acid (including vitamin K antagonists, dipyridamole, dabigatran, apixaban and rivaroxaban), missing data on blood loss in patient chart, missing blood samples in the first 4 days and extra-national patients (follow up not possible). Patients operated on both sides during the inclusion period were only included with data on their latest operation.

研究组 & 干预措施

Clopidogrel

Patients in Clopidogrel or Dual Antiplatelet Therapy (Clopidogrel+Acetylsalicylic acid) at the time of admission AND who are operated <24 hours after admission.

干预措施: Clopidogrel (Drug)

结局指标

主要结局

Surgical Blood Loss

时间窗: at time of surgery

Blood loss as assessed by the surgeon

次要结局

  • Number of transfusions(From admission to third day after surgery)
  • Massive transfusion(within 24 hours of surgery)
  • 30 and 90 day mortality(30 and 90 days postoperatively)
  • Total BLood Loss(From admission to third day after surgery.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Peter Toft Tengberg

Consultant

Hvidovre University Hospital

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