1. What data in particular will be shared?
   Response - All of the individual participant data collected during the trial, after de-identification.
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   Response - Informed Consent Form
   
   
3. Who will be able to view these files?
   Response - Anyone
   


4. For what types of analyses will this data be available?
   Response - To achieve aims in the approved proposal.
   


5. By what mechanism will data be made available?
   Response - Proposals should be directed to [sachinpauljames@gmail.com].
   


6. For how long will this data be available start date provided 01-11-2027 and end date provided 07-01-2031?
   Response - Beginning 9 months and ending 36 months following article publication.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - NIL

Percutaneous nephrolithotomy is a minimally invasive procedure used 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, avoiding neurovascular 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