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临床试验/NCT07686705
NCT07686705已完成不适用

The Effect of Intravenous Versus Intra-articular Tranexamic Acid on Visual Clarity During Arthroscopic Rotator Cuff Repair: A Prospective, Randomized, Double-blind Controlled Trial

Konkuk University Medical Center1 个研究点 分布在 1 个国家目标入组 122 人开始时间: 2022年5月18日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
122
试验地点
1
主要终点
Intraoperative visual clarity

研究概览

简要总结

This single-center, prospective, randomized, double-blind controlled trial evaluated whether intravenous (IV) or intra-articular (IA) administration of tranexamic acid (TXA) improves intraoperative visual clarity, compared with a no-TXA control, during arthroscopic rotator cuff repair. Patients with full-thickness rotator cuff tears were randomly allocated to one of three groups: a control group receiving no TXA; an IA group in which 500 mg of TXA was added to each 1 L of normal-saline irrigation fluid; and an IV group receiving 1000 mg of TXA intravenously 10 minutes before surgery. The operating surgeon graded visual clarity on a 0-10 numeric scale at the end of each of six predefined surgical stages. Secondary outcomes included total operative time, estimated blood loss, irrigation-fluid volume, the number of irrigation-pressure increases, postoperative shoulder swelling, and postoperative day 1 pain.

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
Double (Participant, Outcomes Assessor)

盲法说明

The operating surgeon (outcome assessor) and the patient were blinded to group allocation. Study drug and irrigation fluid were prepared in a separate room by a circulating nurse; only the anesthesia team administering the intravenous agent was aware of allocation.

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-80 years
  • Diagnosed with a rotator cuff tear
  • Failure of conservative treatment for more than 3 months
  • Rotator cuff deemed repairable on magnetic resonance imaging

排除标准

  • Known hypersensitivity to tranexamic acid
  • Previous cerebrovascular accident
  • Coronary stent or other history of thromboembolic disease
  • Anticoagulant therapy
  • Uncontrolled hypertension (systolic pressure > 180 mmHg)
  • Abnormal prothrombin time or activated partial thromboplastin time
  • Acute traumatic rotator cuff tear
  • Irreparable rotator cuff tear

结局指标

主要结局

Intraoperative visual clarity

时间窗: Intraoperatively, at the end of each of the six surgical stages

Surgeon-rated clarity of the arthroscopic surgical field on a 0-10 numeric scale (0 = poorest visualization, 10 = optimal visualization), scored at the end of each of six surgical stages: glenohumeral procedure, subacromial bursectomy, acromioplasty, rotator cuff inspection, medial-row repair, and lateral-row repair.

次要结局

  • Estimated blood loss(From immediately before surgery to immediately after the end of surgery)
  • Total operative time(Intraoperative (duration of surgery))
  • Irrigation-fluid volume(Intraoperatively, from skin incision to skin closure (duration of surgery))
  • Number of irrigation-pressure increases(Intraoperatively, from skin incision to skin closure (duration of surgery))
  • Postoperative shoulder swelling(Baseline (pre-operative) and postoperative day 1)
  • Postoperative pain(Pain assessed using the Visual Analog Scale (VAS) for pain, ranging from 0 (no pain) to 10 (worst imaginable pain); higher scores indicate worse outcome, on postoperative day 1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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