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临床试验/NCT02164565
NCT02164565撤回4 期

The Use of Tranexamic Acid (TXA) Intravenously, to Reduce Blood Loss in Proximal Femur Surgery

HaEmek Medical Center, Israel1 个研究点 分布在 1 个国家开始时间: 2014年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
撤回
试验地点
1
主要终点
Evaluation of blood loss in ml.

研究概览

简要总结

The use of Tranexamic Acid (TXA) intravenously, to Reduce Blood Loss in proximal femur surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • Patients over 60, who came to the orthopedic department for proximal femur fracture surgery
  • Sound judgment

排除标准

  • Known hypersensitivity to Tranexamic Acid or component solution provided
  • Subarachnoid hemorrhage
  • Acquired color blindness
  • Myocardial infarction in 12 months before admission
  • Unstable angina
  • Known clotting disorders (Thromboembolic disease in the past, elongated PT and PTT, hypercoagulability),
  • Kidney or liver failure
  • Another situation prostate resection , pathologic fractures according to anamnesis or by imaging
  • Oncology patients
  • Patients on anticoagulation
  • Patients undergoing vascular intervention ( coronary or peripheral ), which was inserted Supporter requires a Dual antiplatelet therapy

研究组 & 干预措施

Tranexamic Acid (TXA) treatment

Experimental

Tranexamic Acid (TXA) treatment

干预措施: Tranexamic Acid (TXA) treatment (Drug)

结局指标

主要结局

Evaluation of blood loss in ml.

时间窗: up to 13 months

Hbloss=BV X (Hbi - Hbe) X 0.001 + Hbt Hbi - hemoglobin level before the surgery ) gram X liter-1(. Hbe - hemoglobin level 3 days after the surgery ( gram X liter-1). Hbt - The amount of hemoglobin that was given in the blood transfusion (gram). Hbloss - Change of hemoglobin loss. After calculating the amount of loss of hemoglobin, the volume of blood lost can be found: Blood loss = 1000 X Hbloss/ Hbi Evaluation of blood loss will be through: 1. Comparing hemoglobin level before and after surgery and calculation of quantitative Change of hemoglobin loss. 2 .Registration evaluating blood loss at the end of surgery 3. Collecting and recording blood drain. 4. Tracking Blood Transfusion. Of course we collect the data: assessment of bleeding in the analysis, the number of blood units given, the amount of blood collected drain

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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