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临床试验/NCT02233101
NCT02233101已完成不适用

Oral vs. Intravenous TXA Study Proposal: TJA

Rush University Medical Center1 个研究点 分布在 1 个国家目标入组 167 人开始时间: 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
不适用
状态
已完成
入组人数
167
试验地点
1
主要终点
Number of Participants Who Required Blood Transfusion

研究概览

简要总结

Purpose: Examine oral and intravenous Tranexamic Acid (TXA) to determine whether or not the different routes of drug administration are equivalent in terms of post-operative reduction in hemoglobin, number of transfusions, and post-operative blood loss following TJA surgery.

Hypothesis: Oral and intravenous TXA are equivalent routes of drug administration.

详细描述

Purpose: Examine oral and intravenous Tranexamic Acid (TXA) to determine whether or not the different routes of drug administration are equivalent in terms of post-operative reduction in hemoglobin, number of transfusions, and post-operative blood loss following TJA surgery.

Hypothesis: Oral and intravenous TXA are equivalent routes of drug administration.

Background/Scientific review:

Total hip or knee arthroplasty is associated with the risk of moderate to significant blood loss. Techniques such as the use of antifibrinolytics or desmopressin, or normovolaemic haemodilution have been used to reduce the need for allogeneic blood transfusion. Tranexamic acid (TXA) has been used to reduce blood loss and transfusion requirement for total hip and knee arthroplasty, with good results. Approximately one-third of patients undergoing total joint replacement surgery require one to three units of blood postoperatively. Tranexamic acid is a synthetic antifibrinolytic agent that has been successfully used intravenously to control bleeding after total joint replacement. The use of TXA has been shown to significantly reduce the need for blood products during total joint replacement1-4.

There are only a few studies directly comparing outcomes following the use of intravenous tranexamic acid (IVTA) and oral tranexamic acid (OTA) in arthroplasty surgery. In the randomized study by Zohar et al5. OTA (n = 20) was associated with significant allogeneic blood sparing com- pared with controls (n = 20), but not when compared with short- and long-term IVTA regimens. A recent randomized trial comparing OTA (n = 26) with placebo (n = 20) reported significant reductions in blood drained at 24 hours, and in the fall of both Hb and Hct in the OTA group, without any significant difference in the requirement of transfusion6.

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
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Any patient scheduled for a primary TKA or cementless THA with epidural/spinal anesthesia

排除标准

  • Allergy to TXA, acquired disturbances of color vision, refusal of blood products, pre-op use of anticoagulant therapy within five days before surgery, a history of arterial or venous thromboembolic disease (such as DVT, PE, CVA, TIA), pregnancy, breastfeeding, major comorbidities (such as severe ischemic heart disease [New York Heart Association Class III or IV], previous myocardial infarction, severe pulmonary disease, renal impairment, or hepatic failure), patients who decline to participate, any patient undergoing a revision TKA, THA or BHR

研究组 & 干预措施

Oral Tranexamic Acid

Active Comparator

Patients will receive either oral or intravenous Tranexamic Acid

干预措施: Oral Tranexamic Acid (Drug)

Intravenous Tranexamic Acid

Active Comparator

Patients will receive either oral or intravenous Tranexamic Acid

干预措施: Intravenous Tranexamic Acid (Drug)

结局指标

主要结局

Number of Participants Who Required Blood Transfusion

时间窗: during or within 24 hours after surgery

Patient hemoglobin will be measured during and after surgery for the first 24 hours to determine if a blood transfusion is indicated.

次要结局

  • Other Complications(participants will be followed for the duration of hospital stay, an expected average of no more than 30 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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