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临床试验/NCT01370460
NCT01370460已完成2 期

Topical Tranexamic Acid and Acute Blood Loss in Total Knee Arthroplasty

Henry Ford Health System1 个研究点 分布在 1 个国家目标入组 101 人开始时间: 2011年6月最近更新:
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
101
试验地点
1
主要终点
Blood Loss

研究概览

简要总结

This study aims to assess postoperative blood loss and transfusion rates in total knee replacement after one-time administration of topical tranexamic acid.

详细描述

Autologous (donor) blood transfusion is an expensive and common occurrence after total knee replacement. Published data puts this rate between 9 and 40% after primary unilateral total knee arthroplasty. There have been many proposed adjunctive measures to decrease intraoperative and postoperative blood loss during such surgery. Most of these include thrombin inhibition, so-called "minimally- invasive" techniques or instrumentation, or other adjunctive drugs. Hitherto, tranexamic acid, a specific drug that promotes part of the clotting cascade, has been used extensively in multiple areas of surgery with multiple studies evaluating its efficacy in cardiac surgery, spinal procedures, and as a dental swishing solution after tooth extraction. There have been small studies evaluating intravenous tranexamic acid and its effect on total knee replacement, with some promising results. The topical form of TA has been evaluated in only one prospective, randomized clinical trial with a significant decrease in postoperative blood loss and a trend towards decreased autologous blood transfusion rates. This study proposes to further evaluate tranexamic acid as an inexpensive and viable option for use in total knee arthroplasty. The topical form of the drug has been shown to achieve these hemostatic effects without increasing the risk of blood clots after surgery. Furthermore, the one aforementioned randomized clinical trial used a variety of postoperative deep vein thrombosis prophylaxis after surgery and introduced a potential confounding variable. A rigorous analysis of the effects of tranexamic acid demand a more standardized approach. Such a regimen is practiced at Henry Ford Hospital as all patients on the Adult Reconstruction service are placed on an identical dose of enoxaparin (a subcutaneous blood thinner) postoperatively for two weeks.

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
Triple (Participant, Care Provider, 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

  • All adult patients over age eighteen
  • Primary unilateral total knee arthroplasty at Henry Ford Hospital (Detroit, Michigan, United States) and Henry Ford West Bloomfield Hospital (West Bloomfield, Michigan, United States)

排除标准

  • patient history of venous thromboembolic disease or coagulopathy
  • use of anticoagulant medications within 7 days of surgery
  • history of arterial embolic disease
  • history of Class III or IV heart failure
  • renal failure
  • intraoperative cardiovascular, pulmonary, orthopaedic, or anesthetic complication (MI, intraoperative fracture, vasopressor support, emergent intubation).

研究组 & 干预措施

Tranexamic Acid

Experimental

Topical tranexamic acid (2g/100mL) applied during unilateral total knee arthroplasty.

干预措施: Tranexamic Acid (Drug)

Placebo

Placebo Comparator

100mL 0.9% NS, applied topically

干预措施: Placebo (Drug)

结局指标

主要结局

Blood Loss

时间窗: participants will be followed for the duration of hospital stay, an expected average of 3 days

Preoperative and lowest postoperative hemoglobin. Blood loss was calculated taking change in hemoglobin as described (units g/dL) and converting to blood loss (mL) according to the formulas included in the papers cited in this entry (Good 2003 Br J Anesthesia; Nadler 1962 Surgery, http://www.ncbi.nlm.nih.gov/pubmed/21936146).

次要结局

  • Postoperative Transfusion Rate(participants will be followed for the duration of hospital stay, an expected average of 3 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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