A comparitive study of efficacy of preoperative administration of single high dose intravenous tranexamic acid versus multiple boluses of intravenous tranexamic acid in primary total knee arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- -Total blood loss
研究概览
简要总结
This is a randomised parallel group placebo controlled, single centre study to compare the efficacy of intravenous tranexamic acid administration of a single large dose or multiple timed doses in total knee replacement. This study is conducted in sunshine hospitals, Secunderabad, Telangana.
The primary outcomes are blood loss, change in hematocrit levels on 2nd postoperative day.
The secondary outcomes are transfusion rates, deep venous thrombosis, pulmonary embolisation rates.
References:
- Seol YJ, Seon JK, Lee SH, et al. Effect of tranexamic acid on blood loss and blood
transfusion reduction after total knee arthroplasty. Knee Surg Relat Res.
2016;28:188–93. doi:10.5792/ksrr.2016.28.3.188
2. Maniar RN, Kumar G, Singhi T, et al. Most effective regimen of tranexamic acid in
knee arthroplasty: a prospective randomized controlled study in 240 patients. Clin
Orthop Relat Res 2012;470: 2605–12.
- Benoni G, Lethagen S, Fredin H. The effect of tranexamic acid on local and plasma
fibrinolysis during total knee arthroplasty. Thromb Res1997;85:195–206
- Banerjee S, Kapadia BH, Issa K, et al. Postoperative blood loss prevention in total
knee arthroplasty. J Knee Surg 2013;26:395–400
- Seo JG, Moon YW, Park SH, et al. The comparative efficacies of intraarticular and IV
tranexamic acid for reducing blood loss during total knee arthroplasty. Knee Surg
Sports Traumatol Arthrosc 2013;21: Soni A, Saini R, Gulati A, et al. Comparison
between intravenous and intra-articular regimens of tranexamic acid in reducing blood
loss during Total knee arthroplasty. J Arthroplasty 2014;29:1525–7
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Informed consent Those undergoing primary unilateral knee replacement.
排除标准
- •Abnormal PT/APTT/INR or coagulopathic diseases Undergoing B/L TKR / revision surgeries of any cause Past h/o thromboembolic events Treated with Aspirin or any anti-platelets within 1 week prior to the surgery TKR done for secondary OA (rheumatoid arthritis, post traumatic arthritis) History of reported allergy to tranexamic acid Pre operative hemoglobin <8gm/dl Chronic renal insufficiency.
结局指标
主要结局
-Total blood loss
时间窗: -Total blood loss | -Change in hematocrit levels on post-operative day 2
-Change in hematocrit levels on post-operative day 2
时间窗: -Total blood loss | -Change in hematocrit levels on post-operative day 2
次要结局
- 1.Transfusion rates(2.Deep vein thrombosis)