跳至主要内容
临床试验/NCT04594408
NCT04594408已完成4 期

The Use of Tranexamic Acid in Irrigation Fluid to Improve Arthroscopic Visualization in Shoulder Surgery: A Randomized Controlled Trial

Panam Clinic1 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2020年9月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
128
试验地点
1
主要终点
Visualization Quality Scale

研究概览

简要总结

The purpose of this study is to determine if intravenous TXA is a safe alternative to epinephrine in improving arthroscopic shoulder visualization.

Primary Objectives

  1. Determine that patients given intravenous tranexamic acid improves surgeon-rated visualization compared to placebo.
  2. Determine that intravenous tranexamic acid is a safe alternative to epinephrine mixed irrigation fluid to improve arthroscopic shoulder visualization

详细描述

In the last twenty years, the use of arthroscopy to surgically manage shoulder pathologies has expanded in its indications. The interplay between increased indications, surgeon experience, and improvements in equipment have all propelled arthroscopic shoulder surgery to preferred treatment in managing instability, rotator cuff, and impingement pathology. Obtaining adequate visual clarity is paramount to performing the procedures safely, efficiently, and effectively.

A variety of methods have been employed to improve visualization. This includes tighter control of blood pressure, regional anesthetic, pressure controlled irrigation system, sealed cannulas, electrocautery devices, and injecting epinephrine into irrigation fluid. The use of epinephrine in irrigation fluid has been studied in literature. The results of a few randomized controlled trials demonstrate that the vasoconstrictive properties of epinephrine decrease blood flow and consequently, improves surgeon visualization. However, there has been reports of ventricular tachycardia, lethal arrhythmias, and epinephrine induced pulmonary edema in literature that suggests that the addition of epinephrine in irrigation fluid may have caused these adverse events. Therefore, it is important to examine other alternatives, such as TXA, that can decrease bleeding and improve visualization without potential detrimental effects.

This trial will be conducted in compliance with the protocol, GCP, and the applicable regulatory requirements.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

Surgeons are blinded to group allocation as all IV bags will have labels appearing identical when turned away from the surgeon. Anesthetists are told not to reveal allocation to the surgeon as well. And patients will not be informed of their allocation.

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

  • Able to read and understand patient consent form and give informed consent
  • Rotator cuff pathology or impingement that have clinical indications for shoulder arthroscopy surgery (either rotator cuff repair or subacromial decompression

排除标准

  • Have an active thromboembolic event
  • Allergies or hypersensitivies to TXA or any of the ingredients
  • Have a seizure disorder
  • On hormonal contraceptives
  • History of venous thromboembolism in the previous 12 months, or requiring lifelong anticoagulation related to previous VTE. VTE is defined as a cerebrovascular event (stroke, transient ischemic attack, deep vein thrombosis, and pulmonary embolism or with a history of hypercoagulable disorders (i.e. Factor V Lieden, antiphospholipid antibody)
  • Acquired disturbances of colour vision
  • Hematuria with renal cause

研究组 & 干预措施

Epinephrine in irrigation fluid

Active Comparator

Epinephrine intervention used.

干预措施: Epinephrine (Drug)

Intravenous TXA

Experimental

Tranexamic acid intervention used.

干预措施: Tranexamic acid (Drug)

Epinephrine and TXA

Experimental

Epinephrine and tranexamic acid intervention used.

干预措施: Epinephrine and Tranexamic Acid (Drug)

结局指标

主要结局

Visualization Quality Scale

时间窗: Intra-operative

Surgeons are asked every 15 minutes to report on the quality of visualization based on a 4-point scale. Minimum value is 0, maximum value is 3 with the higher value reflecting improved visualization

次要结局

  • Patient Log Book for Pain and Medications(Day of surgery - post-operative day 14)

研究者

发起方
Panam Clinic
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验