The Effect of Tranexamic Acid on Calculated Total Blood Loss in Patients Undergoing Revision Shoulder Arthroplasty
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Total Surgical Drain Output
研究概览
简要总结
This is a phase IV, randomized, single-blind, single-center study comparing calculated total blood loss, surgical drain output and hematoma formation in patients who receive 2 doses of Tranexamic Acid (TXA) versus control group undergoing revision total shoulder arthroplasty. Patients will be randomized to either receive 2 doses of IV TXA, first dose prior to surgical incision and second dose given 3 hours later or to the control group, where no TXA will be administered.
详细描述
The objectives of the study are to compare the effectiveness of IV TXA on reducing calculated total blood loss, surgical drain output and hematoma formation in patients undergoing revision total shoulder arthroplasty.
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, Care Provider)
盲法说明
Neither the anesthesiologist or surgeon will be blinded to the patient's group assignment, as they will be the one performing the treatment. All other stakeholders (patient, other caregivers, and research staff collecting the data) will be blinded to the patient's group assignment.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 18 years old
- •Patients younger than 90 years old
- •Patients undergoing scheduled revision total shoulder arthroplasty
- •Patients who consent to be randomized
排除标准
- •Patients younger than 18
- •Patients older than 90 years old
- •Patients who are pregnant or breast-feeding women
- •Patients who are allergic to tranexamic acid
- •Patients with proximal humerus fracture or fracture sequelae
- •Patients who use estrogen containing medications (i.e. oral contraceptive pills)
- •Patients who have acquired disturbances of color vision
- •Patients with a history of any of the following diagnosis: '
- •Subarachnoid hemorrhage
- •Active intravascular clotting
- •Severe pulmonary disease (FEV <50% normal)
- •Plasma creatinine > 115 μmol/L in males, > 100 μmol/L in females, or hepatic failure)
- •(Renal impairment serum creatinine > 1.5 times the upper limit of normal NYU)
- •Preoperative anemia [Hemoglobin (Hb) < 11g/dL in females, Hb < 12 g/dL in males]
- •Patients who refuse blood products
- •Patients undergoing hormone replacement therapy
- •Patients with diagnosed or self-reported cognitive dysfunction;
- •Patients who are unable to understand or follow instructions;
- •Patients with severe liver disease, renal insufficiency, congestive heart failure, and/or significant heart disease;
- •Patients with BMI over 50
- •Any patient that the investigators feel cannot comply with all study related procedures.
研究组 & 干预措施
Tranexamic acid (TXA) Injection
Participants scheduled for Revision Total Shoulder Arthroplasty (TSA) will receive two injections of TXA.
干预措施: Tranexamic acid (TXA) injection (Drug)
结局指标
主要结局
Total Surgical Drain Output
时间窗: up to 24 hours post-op
The floor nurse will also document the amount of blood in the indwelling hemovac surgical drain placed in the operative shoulder joint up to 24 hours. The total surgical drain output will be calculated after 24 hours.
Total Calculated Total Blood Loss
时间窗: up to 24 hours post-op
The volume of perioperative blood loss will be determined on the basis of the blood volume and change in hemoglobin from preoperatively to 1 day postoperatively. The volume of total perioperative blood loss will be determined according to the following formula: Total blood loss (ml) = 1000 x 〖Hb〗_loss/〖Hb〗_i
次要结局
- Number of Participants With Presence of Hematoma(2 weeks post-op)
- Number of Participants Who Needed a Post-op Blood Transfusion(2 weeks post-op)
- Average Operative Time(During operation, up to 4 hours)