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临床试验/NCT02989155
NCT02989155已完成不适用

Tranexamic Acid Use and Blood Loss in Total Hip Arthroplasty

Ohio State University1 个研究点 分布在 1 个国家目标入组 576 人开始时间: 2016年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
576
试验地点
1
主要终点
hemoglobin, hematocrit, and red blood cell transfusion rates

研究概览

简要总结

The purpose of this study is to determine the need for a blood transfusion during surgery and to evaluate the levels of certain proteins in the blood when given tranexamic acid.

详细描述

A review of the medical record between January 01 2013 to July 1st 2015 will be used to determine if the hypothesis that patients receiving tranexamic acid will have a lower need for blood transfusion and there are changes in the levels of the proteins essential for healthy oxygen transport throughout the body is correct. Tranexamic acid is a medication which may help wounds to stop bleeding more quickly. Participants are not expected to receive any direct benefits from participating in this study. Only a small risk of private patient medical information being exposed is anticipated. The results of this study will help surgeons and the medical community to better understand the uses of this type of drug and its possible role in benefiting hip replacement patients during and following surgery.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

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

  • Adult patients 18 years of age and older
  • Surgical patients who underwent primary total hip arthroplasty (THA)
  • Surgical patients who underwent revision THA
  • Preoperative hemoglobin values (N) 11 g/dl
  • Normal international normalized ratio (INR), prothrombin time (PT), partial thromboplastin time (PTT) values

排除标准

  • - Allergy to tranexamic acid
  • Bilateral THA
  • History of ischemic heart disease
  • Severe chronic heart failure
  • Hepatic dysfunction
  • Chronic renal failure
  • On hemodialysis
  • Cerebral infarction
  • History of seizure
  • Bleeding disorder
  • Anticoagulant or aspirin-like medication and long acting NSAID medication
  • Short acting NSAID's were discontinued at least 24 hrs before surgery

结局指标

主要结局

hemoglobin, hematocrit, and red blood cell transfusion rates

时间窗: Peri-operative care

Whether intraoperative dose of 2gr tranexamic acid (TXA) in patients having primary or revision THA would decrease the perioperative and post-operative reduction in hemoglobin, hematocrit, and red blood cell transfusion rates compared with those of a similar group of patients who did not receive TXA (control group).

次要结局

  • clinically-significant venous thromboembolism (VTE) and all-cause mortality(within 30 days of surgery)

研究者

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

Nicoleta Stoicea

Research Scientist/ Adj. Assistant Professor

Ohio State University

研究点 (1)

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