Efficacy of Intravenous and Topical Tranexamic Acid to Control Perioperative Blood Loss in Bipolar TURP
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- 1.Drop in the Haemoglobin and Hematocrit level
研究概览
简要总结
Background and study aims
The role of tranexamic acid (TXA) in urologic surgery, and especially transurethral resection of the prostate (TURP), is under investigation, and a few studies in support of its efficacy have been published. However, there needs to be more consensus regarding dose, route of administration and efficacy profile for TXA during TURP. This study aims to evaluate the efficacy, safety and preferred route of administering TXA to control TURP-associated bleeding- either by intravenous route or the irrigation fluid route to directly target the bleeding site, while comparing it with the control group.
Study hypothesis-
Administration of tranexamic acid (TXA) via intravenous and irrigation fluid routes significantly reduces the incidence and severity of bleeding during transurethral resection of the prostate (TURP) compared to standard care, with the intravenous route demonstrating superior efficacy in controlling intraoperative blood loss and improving postoperative outcomes.
Study Design-
This is a prospective single-centre intervention study with patients undergoing transurethral resection of the prostate (TURP) for lower urinary tract symptoms (LUTS ) attributable to benign prostatic hyperplasia (BPH) and gland size between 40-100 g and aged between 50-90 years being allocated into 3 groups:
Group 1- Receiving 1 gm tranexamic acid intravenously 20 min before TURP
Group 2- Receiving 500 mg tranexamic acid in every 3 litres of irrigation fluid (Up to a maximum of 2 gm)
Group 3- Control/Placebo group
The study participants will be randomised into 3 groups using the block randomisation technique. It will be a single-blinded study. Blood loss will be estimated by recording haemoglobin and hematocrit 4 h post-operatively and on the first postoperative day. Other parameters such as resection time, intraoperative endoscopic vision, irrigation fluid volume and complications will be noted.
Possible benefits and risks to participating patients
Benefit- Reduction in TURP associated blood loss. Reduced requirement for blood transfusion.
Risk- Marginally increased risk of Deep Vein Thrombosis (DVT)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 50.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- Male
入选标准
- •Bothersome LUTS and proven prostatic enlargement based on digital rectal examination and abdominal ultrasonography with gland size 40-100 cc
- •Age 50-90 years.
排除标准
- •History or evidence of prostate disease other than BPH, previous prostate surgery
- •Severe cardiopulmonary disease
- •Patients requiring treatment with anti-platelets, or anticoagulants in the immediate perioperative period and severe medical conditions such as liver disease, or bleeding disorders
- •End Stage Renal Disease.
结局指标
主要结局
1.Drop in the Haemoglobin and Hematocrit level
时间窗: 4 Hrs, 24hrs and 1 week.
2. Any Change in the Volume of irrigation fluid used after TURP
时间窗: 4 Hrs, 24hrs and 1 week.
3. complications- specifically Deep Vein Thrombosis.
时间窗: 4 Hrs, 24hrs and 1 week.
次要结局
- Incidence of Clot retention or hematuria or deep vein thrombosis(1 month 3 months)
研究者
Manoj Kiran Vaidya
BLDE Deemed to be University