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临床试验/NCT03212365
NCT03212365已完成2 期

Minimization of Bleeding Related Adverse Drug Events in Plastic & Reconstructive Surgery Patients Randomized to Different Postoperative Anticoagulant Regimens

University of Utah2 个研究点 分布在 1 个国家目标入组 295 人开始时间: 2017年7月3日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
295
试验地点
2
主要终点
Avoidance of Over-anticoagulation (Peak aFXa >0.4 IU/mL)

研究概览

简要总结

Plastic and reconstructive surgeons consistently create large, raw surfaces as part of their operative procedures. Thus, plastic & reconstructive surgery patients are among those at highest risk for anticoagulant-associated bleeding adverse drug events (ADEs). This study seeks to optimize both the safety and effectiveness of post-operative enoxaparin by comparing aFXa levels, bleeding events, and VTE events among plastic & reconstructive surgery patients randomized to receive two different enoxaparin dose regimens.

详细描述

Plastic and reconstructive surgeons consistently create large, raw surfaces as part of their operative procedures. Thus, plastic & reconstructive surgery patients are among those at highest risk for anticoagulant-associated bleeding adverse drug events (ADEs). Our preliminary data has shown that a fixed, or "one size fits all" dose of enoxaparin, an anticoagulant, can allow a high proportion of patients to have appropriately thinned blood, measured by anti-Factor Xa (aFXa) levels. Patients with adequate aFXa levels are known to have significantly decreased venous thromboembolism risk (VTE), which is desirable. However, 30% of patients who receive fixed dose enoxaparin have blood that is too thin. Patients who are over-anticoagulated are significantly more likely to have ADEs including bleeding requiring return to the operating room, need for blood transfusion, or death. The optimal way to dose enoxaparin to minimize ADEs remains unknown. This study seeks to optimize both the safety and effectiveness of post-operative enoxaparin by comparing aFXa levels, bleeding events, and VTE events among plastic & reconstructive surgery patients randomized to receive two different enoxaparin dose regimens.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Investigator)

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

  • receiving plastic and reconstructive surgery under general anesthesis
  • Expected post-operative stay of 2 days or more

排除标准

  • Contraindication to use of enoxaparin
  • intracranial bleeding/stroke
  • Hematoma or bleeding disorder
  • Heparin-induced thrmbocytopenia positive
  • Creatinine clearance less than or equal to 30 mL/min
  • Serum creatinine greater than 1.6 mg/dL
  • epidural anesthesia
  • patients placed on non-enoxaparin chemoprophylaxis regimens
  • gross weight exceeding 150kg

研究组 & 干预措施

Fixed Dose

Other

Participants will receive 40 mg enoxaparin twice daily

干预措施: Fixed dose (Drug)

Variable Dose

Experimental

Participants will receive 0.5mg/kg enoxaparin twice daily

干预措施: Variable dose (Drug)

结局指标

主要结局

Avoidance of Over-anticoagulation (Peak aFXa >0.4 IU/mL)

时间窗: Four hours following third enoxaparin dose

Avoidance of over-anticoagulation (peak aFXa \>0.4 IU/mL)

Avoidance of Under-anticoagulation (Peak aFXa <0.2 IU/mL)

时间窗: Four hours following third enoxaparin dose

Avoidance of under-anticoagulation (peak aFXa \<0.2 IU/mL)

次要结局

  • Percentage of Patients With Bleeding Events(90 days)
  • Percentage of Participants With Venous Thromboembolism Events(90 days)

研究者

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

Christopher Pannucci

Assistant Professor

University of Utah

研究点 (2)

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