Topical (Intra-Articular) Tranexamic Acid and Transfusion Rates Following Hip Hemiarthroplasty
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Number of Participants Who Needed Transfusions
研究概览
简要总结
This study is a double-blinded placebo-controlled clinical trial evaluating the efficacy of 1 gram of topically applied tranexamic acid vs. saline placebo for the reduction of transfusion following hip hemiarthroplasty surgery.
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)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing hip hemiarthroplasty surgery for a displaced femoral neck fracture
排除标准
- •History of hemophilia, history of deep vein thrombosis, history of pulmonary embolism, history of thrombophilia, history of chronic renal failure
- •Patients with coronary ischemia (active or within the past calendar year), patients who have suffered a myocardial infarction, undergone percutaneous coronary intervention, undergone coronary artery bypass grafting, or undergone any revascularization procedure within the past calendar year
- •Patients with active subarachnoid hemorrhage, acquired defective color vision, patients who sustained a pathologic fracture (fracture through a neoplastic lesion), or patients who are pregnant
- •Patients with a known allergy to tranexamic acid
- •Patients taking Warfarin, Dabigatran, Rivaroxaban, Apixaban, and Fresh Frozen Plasma
研究组 & 干预措施
Tranexamic Acid
Patients will receive 1 gram of topically applied tranexamic acid into their surgical wound at the time of wound closure during their hip hemiarthroplasty surgery. 1 gram of tranexamic acid will be mixed with normal saline to a total volume of 50 cc, half of which will be delivered intra-articularly and half of which will be delivered in the subfascial space.
干预措施: Tranexamic Acid (Drug)
Placebo
Patients will receive 50 cc of topically applied normal saline into their surgical wound at the time of wound closure during their hip hemiarthroplasty surgery. Half of this 50 cc dose of normal saline will be delivered intra-articularly and half will be delivered in the subfascial space.
干预措施: Placebo (saline) (Drug)
结局指标
主要结局
Number of Participants Who Needed Transfusions
时间窗: From the time of surgery until 2-4 days post-operative (length of inpatient hospital stay)
The rate of transfusion will be calculated for each study group.
次要结局
- Inpatient Transfusion Amount(2-4 days post-operative (length of inpatient hospital stay))
- Difference Between Pre/Post-operative Hemoglobin(Pre-operative hemoglobin level vs. post-operative day 1 hemoglobin level)
- Difference Between Pre/Post-operative Hematocrit(Pre-operative hematocrit level vs. post-operative day 1 hematocrit level)
- Length of Inpatient Hospital Stay(From date of hospital admission until the date of hospital discharge or date of death from any cause, whichever comes first, assessed up to 42 days post-operatively)
- Number of Participants With Post-operative Complications(Admission to second post-operative visit (4-6 weeks post-operative))
- Inpatient Hospitalization Cost(Collected 4-6 weeks post-operative)