title: A double-blind, placebo-controlled randomized clinical trial to evaluate the efficacy of tranexamic acid in irrigant solution on blood loss during percutaneous nephrolithotomy: a pilot study from tertiary care center of North India.
abstract: OBJECTIVE
  To evaluate the efficacy and safety of 0.1% tranexamic acid in irrigant fluid in reducing blood loss during PCNL.
  
  
  METHODS
  The study involved 400 patients who were planned for PCNL and were prospectively randomized into two equal groups. In tranexamic group, 0.1% tranexamic acid was given in irrigant fluid, while in placebo group, distilled water was added to irrigant fluid during surgery. Operative data were recorded which included fall in hemoglobin, total blood loss, operative time, irrigation fluid, length of stay in hospital, requirement of blood transfusion, complications related to PCNL and adverse events of tranexamic acid.
  
  
  RESULTS
  Baseline parameters were comparable between two groups. The fall in hemoglobin and total blood loss in the tranexamic group was significantly lower than placebo group (1.71 vs. 2.67 gm/dL, 154.55 vs. 212.61 mL, respectively, p < 0.0001). Operative time, amount of irrigation fluid used and hospital stay of tranexamic group were significantly less compared to placebo (p < 0.05). Complete stone clearance rate was 88% in tranexamic group versus 82% in placebo (p = 0.12). The blood transfusion requirement was significantly lower in the tranexamic group versus placebo (5 vs. 12.5%, p = 0.012), as was the complication rate (19 vs. 28%, p = 0.044). The requirement of angioembolization in the tranexamic group was significantly less as compared to placebo (0.5 vs. 4%, p = 0.03). No adverse events related to administration of tranexamic acid were noted.
  
  
  CONCLUSIONS
  0.1% tranexamic acid in irrigant fluid is safe and significantly reduces perioperative blood loss and requirement of blood transfusion during percutaneous nephrolithotomy. It is associated with lower perioperative complication rates.
authors.affiliation: Janak Surgicare Centre, Patiala, Punjab, India. ankurbansaldmc@gmail.com.
authors.forename: Ankur
authors.initials: A
authors.lastname: Bansal
authors.affiliation: Janak Surgicare Centre, Patiala, Punjab, India.
authors.forename: Aditi
authors.initials: A
authors.lastname: Arora
mesh_terms: D000328:Adult; D000933:Antifibrinolytic Agents / Q000627:therapeutic use*; D016063:Blood Loss, Surgical / Q000517:prevention & control*; D001803:Blood Transfusion / Q000706:statistics & numerical data; D004311:Double-Blind Method; D005260:Female; D006454:Hemoglobins / Q000378:metabolism; D006801:Humans; D007194:India; D007669:Kidney Calculi / Q000601:surgery*; D007902:Length of Stay; D008297:Male; D008875:Middle Aged; D000074642:Nephrolithotomy, Percutaneous / Q000379:methods*; D061646:Operative Time; D010865:Pilot Projects; D012996:Solutions / Q000627:therapeutic use; D062606:Tertiary Care Centers; D007507:Therapeutic Irrigation / Q000379:methods; D014148:Tranexamic Acid / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000933:Antifibrinolytic Agents; D006454:Hemoglobins; D012996:Solutions; D014148:Tranexamic Acid
keywords: Blood loss; Irrigant; Percutaneous nephrolithotomy; Tranexamic acid