Does Tranexamic Acid Improve Visualization During Arthroscopic Rotator Cuff Repair: A Double Blinded, Randomized Control Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Arthroscopic Visualization Score
研究概览
简要总结
This clinical trial examines whether intravenous preoperative administration of tranexamic acid (TXA) before arthroscopic rotator cuff repair (ARCR) can improve arthroscopic visualization during the procedure.
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 and all treatment is administered by the anesthesia care provider. Patients will not be informed of their allocation.
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-100
- •Male and Female
- •Patient able to read and understand consent form
- •Non-traumatic, simple small or medium sized rotator cuff tear as defined by pre-operative MRI
- •Booked to operating room for elective rotator cuff repair
- •Beach chair positioning
排除标准
- •Patient refusal to participate
- •Massive rotator cuff tear
- •Acute traumatic rotator cuff tear
- •Known coagulopathy
- •Patients with a history or risk of thromboembolism
- •Known hypersensitivity to tranexamic acid
- •Patient unable to be off anti-coagulant medication for long enough to counter effects
- •Patient has a clinic systolic blood pressure > 150mmHg
- •Lateral positioning
- •Requirement or insistence by patient or anesthesiologist on regional block
- •Patients who have smoked nicotine products within the last year
- •The presence of other inflammatory conditions (calcific tendonitis, rheumatoid arthritis, etc.)
- •The presence of active thromboembolic disease, such as deep vein thrombosis, pulmonary embolism, and cerebral thrombosis
- •Patient has a seizure disorder
- •Patients on medications identified as having drug-drug interactions (hormonal contraceptive, hydrochlorothiazide, desmopressin, sulbactam-ampicilllin, carbazochrome, ranitidine, or nitroglycerine
- •Patient is pregnant
- •Patients with history of subarachnoid hemorrhage
- •Patients with renal insufficiency
- •Patients with acquired disturbances of color vision
研究组 & 干预措施
Intravenous Tranexamic Acid
1g of Tranexamic Acid will be administered intravenously prior to the start of the operation.
干预措施: Tranexamic Acid 100 MG/ML (Drug)
结局指标
主要结局
Arthroscopic Visualization Score
时间窗: Surgeon will complete the visualization score immediately after the surgery is completed.
A visualization score from 1 to 6 assessed by the surgeon. 1. - Perfect visualization 2. - Mild difficulty that could easily be worked around 3. - Moderate difficulty that required modifications to the surgical plan 4. - Significant difficulty that added more than 10 minutes to the case 5. - Major difficulty that added more than 20 minutes to the case 6. - Difficulty that forced the stoppage of the case
次要结局
未报告次要终点
研究者
Jeremy Reed
Principle Investigator
University of Saskatchewan