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临床试验/CTRI/2024/12/077851
CTRI/2024/12/077851尚未招募2 期

The role of tranexamic acid in patients with renal stones undergoing Percutaneous Nephrolithotomy: a randomised double blinded placebo controlled trial

CMC Vellore1 个研究点 分布在 1 个国家目标入组 260 人开始时间: 2024年12月20日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
260
试验地点
1
主要终点
The occurance of blood transfusion in PCNL

研究概览

简要总结

Percutaneous nephrolithotomy is a minimally invasive procedureused for treating symptomatic renal stones, larger than 2cm. For complex renal stones, PCNL has the advantage of higher stone clearance and cost effectiveness compared to Shock wave lithotripsy or Retrograde intrarenal surgery. However, the need for blood transfusion (7%transfusion rate globally) remained one of the most common complications of PCNL. 1 According to Indian dats the transfusion rates in PCNL is around 12%. 2 Blood transfusions have rare but potentially serious adverse effects including hemolytic reactions, acute lung injury, coagulopathic complications from massive transfusion, nonimmune haemolysis and transfusion related infections.

 In order to minimize the need for blood transfusion, many methods like routine use of nephrostomy tube, avoidingneurovascular bundle, use of sealant in the nephrostomy tract have been used. 2 However, none of these are completely efficient in controlling bleeding.  Tranexamic acid (TXA) is a synthetic derivative of the amino acid lysine that blocks fibrinolysis through occupation of lysine-binding domains of plasminogen. It acts as a reversible competitive inhibitor of plasminogen, preventing its activation into plasmin by tissue plasminogen activator. Through this mechanism, TXA prevents clot dissolution and stabilizes fibrin matrices and can be used to reduce surgical blood loss in a variety of surgical settings. Intravenous administration of tranexamic acid has been reported to decrease perioperative blood loss during liver surgery, cesarean sections, cardiac surgery, gynecologic cancer surgeries, orthopedic surgery, transurethral resection of prostate (TURP), radical prostatectomy and PCNL without increasing the risk of thromboembolic complications. 4 Even though TXA was proven to decrease the occurrence of blood transfusion in PCNL according to many RCTs, still trials are lacking to determine the optimal dose and route of administration for this drug. 5

 1.      Batagello CA, Vicentini FC, Monga M, et, al Tranexamic acid in patients with complex stones undergoing percutaneous nephrolithotomy: a randomised, double-blinded, placebo-controlled trial. BJU Int. 2022

 2.      Kumar S, Randhawa MS, et al Tranexamic acid reduces blood loss during percutaneous nephrolithotomy: a prospective randomized controlled study. J Urol. 2013

 3.      Siddiq A, Khalid S, et al, Preventing Excessive Blood Loss During Percutaneous Nephrolithotomy by Using Tranexamic Acid: A Double Blinded Prospective Randomized Controlled Trial. J Urol Surg 2017

 4.      Mohammadi M, Nouri-Mahdavi K et al, Effects of Tranexamic Acid on Bleeding and Haemoglobin Levels in Patients with Staghorn Calculi Undergoing Percutaneous Nephrolithotomy: Randomized Controlled Trial. Iran J Med Sci. 2019

 5.      Prasad S, Sharma G, et al Is tranexamic acid associated with decreased need for blood transfusion in percutaneous nephrolithotomy: a systematic review and meta-analysis. The Annals of The Royal College of Surgeons of England. 2023

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • 1.Age 18 years or more 2.Baseline Hb more than 10g/dl.
  • 3.patients undergoing percutaneous nephrolithotomy.

排除标准

  • patients with known allergy to tranexamic acid
  • Patients on anti-platelets or anti coagulation therapies.
  • 3 Patients with history of venous thrombosis or pulmonary embolism
  • Non ambulant patients
  • CAD with drug eluting stent required Dual antiplatelet agents
  • CKD with MDRD less than 30ml/min/1.73m2
  • Patient’s refusal
  • Diagnosed with mental condition that impair the patient’s ability to provide informed consent.

结局指标

主要结局

The occurance of blood transfusion in PCNL

时间窗: From surgery till discharge

次要结局

  • Blood loss, operative time, Success rate, intra operative hypotension requiring vasopressors, Need for secondary procedures, complications, readmissions(Intra op, immediate post op, after six months post op)

研究者

发起方
CMC Vellore
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Sachin Paul James

CMC Vellore

研究点 (1)

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