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Tranexamic Acid

Tranexamic acid (TXA) is a synthetic lysine-analogue antifibrinolytic that can reduce blood loss or transfusion in selected surgical settings; benefits and safety depend on procedure, patient and regimen. For the reconstructive and pelvic surgeon the relevant questions are narrow: when does the blood-loss reduction justify giving it, and when is it dangerous? The answer to the second is uniquely urologic.[8][9]

Mechanism — and Why the Urinary Tract Is Special​

TXA competitively blocks the lysine-binding site on plasminogen, preventing its conversion to plasmin and thereby stabilizing fibrin clots.[3] The urinary tract is uniquely rich in plasminogen activators; urokinase and high urinary plasminogen drive local fibrinolysis and clot breakdown.[1][3] TXA's antifibrinolytic action directly counteracts this local fibrinolytic milieu, which is both why it is pharmacologically well-suited to urologic bleeding and why it carries a urology-specific hazard (clot retention in the upper tract; see Safety). TXA is renally excreted (urinary excretion falls as creatinine rises), so it concentrates exactly where the fibrinolysis is.[17]

Evidence Across Urologic Surgery​

The 2026 POISE-3 prespecified urologic analysis included 1,124 participants with bleeding and cardiovascular risk factors. With 1 g IV at the start and end of surgery, the primary bleeding composite occurred in 8.1% versus 10.9% (HR 0.73, 95% CI 0.50–1.07), which did not reach statistical significance. The major-bleeding component was lower, 6.1% versus 9.5% (HR 0.63, 95% CI 0.41–0.97). The safety composite was 12.1% versus 10.9% (HR 1.12, 95% CI 0.79–1.58); few stroke and VTE events limit precision. No subgroup interaction was detected.[8]

TRACTION, June 2026: a cluster-randomized crossover policy trial across 10 Canadian hospitals, with 8,273 evaluable patients undergoing major noncardiac surgery, found fewer in-hospital red-cell transfusions with TXA (7.4% versus 9.8%; adjusted RR 0.73, 95% CI 0.61–0.86). Ninety-day VTE was 2.1% in both groups (RR 0.96, 95% CI 0.65–1.38), meeting the prespecified noninferiority margin of 1.46. Most operations were oncological.[19]

A 13-RCT urologic meta-analysis (1,814 participants) also reported lower blood loss and transfusion; sparse thrombotic events limit safety conclusions.[9]

The procedure-specific trials that built this base, drawn largely from prostate, cystectomy, and stone surgery, are summarized here as the evidence the general recommendation rests on:

SettingKey finding
Prostate surgeryMeta-analysis (9 RCTs): reduced EBL (SMD −1.93) and transfusion (RR 0.61) with no detected DVT/PE difference in the included trials.[4] Landmark RRP RCT (n=200): any blood-product transfusion 55% → 34% (NNT 5), thromboembolic events by 6 mo: 2/100 versus 5/100 (RR 0.40, 95% CI 0.09–1.74).[5] In a single-center bipolar TURP RCT (n=65; 10 mg/kg over 30 min, then 5 mg/kg/h for 12 h), TXA gave a smaller hemoglobin drop (1.0 vs 1.6) and shorter irrigation (24 vs 38 h) and catheterization (41 vs 54 h); no patient was transfused.[2] A TURP-only synthesis of 13 randomized or quasi-randomized trials (n=1,140) found a smaller postoperative hemoglobin decline (mean difference −0.58 g/dL, 95% CI −0.95 to −0.22); the transfusion estimate was RR 0.71 (95% CI 0.46–1.10).[26] The TURP benefit is usually attributed to urokinase released from prostatic tissue.
Radical cystectomyTACT, a 10-center RCT of open radical cystectomy for bladder cancer (353 randomized; 344 analyzed), found no statistically detected difference in red-cell transfusion within 30 days (64/173 [37.0%] with TXA versus 64/171 [37.4%] with placebo; RR 0.99, 95% CI 0.83–1.18); VTE within 30 days occurred in 6/173 versus 5/171 (p = .57).[6] A propensity-matched series of 32 pairs using a simplified 1 g bolus reported transfusion in 19% with TXA versus 47% without TXA.[7] A meta-analysis of five radical-cystectomy reports associated TXA with fewer perioperative transfusions (OR 0.56, 95% CI 0.32–0.97) and more thromboembolic events (OR 2.05, 95% CI 1.15–4.65).[24] A later analysis excluding an overlapping cohort pooled one RCT and two matched observational studies (n=1,344), with imprecise estimates for perioperative transfusion (RR 0.69, 95% CI 0.25–1.86) and VTE (RR 1.60, 95% CI 0.80–3.17).[25]
PCNLCochrane review: 10 systemic-TXA RCTs (1,883 participants) and one topical trial (400). Systemic TXA may reduce transfusion; stone-free benefit is uncertain (RR 1.11, 95% CI 0.98–1.27). Thrombotic events were sparse.[1]

Hematuria Management (Non-Surgical)​

Outside the OR, TXA has been studied off-label for gross hematuria. A review of 7 heterogeneous studies (970 participants) describes possible benefits.[10]

  • IV TXA was studied for postoperative hematuria;
  • oral and intravesical approaches were also reported in non-surgical settings, without a definitive head-to-head route hierarchy;
  • a pilot RCT in 50 patients with painless lower-tract hematuria found lower 24-hour bladder-irrigation volume with intravesical TXA, without a significant difference in hemoglobin decline or transfusion.[11]

Investigate the bleeding source and preserve drainage; TXA must not delay clot evacuation, decompression or treatment of a tumor, infection or vascular injury.

Dosing​

The following are study regimens, not interchangeable prescriptions. US CYKLOKAPRON approval is for short-term bleeding prevention in hemophilia around dental extraction; urologic uses are off-label. Confirm local protocol, renal function and administration rate.[17]

SettingProtocol
POISE-3 urologic subgroup (inpatient noncardiac surgery with bleeding and cardiovascular risk factors)1 g IV at surgery start + 1 g at end[8][18]
Radical retropubic prostatectomy500 mg IV load 20 min before surgery + 250 mg/h infusion intraop[5]
Bipolar TURP (single-center RCT)10 mg/kg IV over 30 min before induction + 5 mg/kg/h for 12 h[2]
Radical cystectomy (TACT)10 mg/kg IV load + 5 mg/kg/h infusion intraop[6]
Radical cystectomy (simplified)1 g IV bolus preoperatively[7]
Intravesical (painless lower-tract hematuria)Pilot RCT (n=50): TXA instilled into the bladder via catheter during bladder irrigation[11]

Renal impairment requires dose reduction (renal excretion leads to accumulation). The label's adjustment table (written for the hemophilia regimen of 10 mg/kg) is by serum creatinine: 1.36–2.83 mg/dL, 10 mg/kg twice daily; 2.83–5.66 mg/dL, 10 mg/kg daily; above 5.66 mg/dL, 10 mg/kg every 48 h or 5 mg/kg every 24 h. Perioperative regimens have no validated equivalent, so reduce the dose and involve anesthesia when creatinine is elevated. Infuse undiluted CYKLOKAPRON at 0.5 mL/min (50 mg/min), never faster than 1 mL/min (100 mg/min), to avoid hypotension.[17]

Safety and Contraindications​

Thromboembolism. Small urologic trials and meta-analyses generally did not detect an increase.[4][8][9][12] The original 2022 POISE-3 trial did not establish noninferiority for its broad cardiovascular composite; TRACTION subsequently met its specified VTE noninferiority margin. These outcomes and margins are different.[18][19]

Upper-tract hematuria and clot obstruction. Stabilized urinary clots can obstruct the renal pelvis or ureter. Avoid reflexive systemic TXA for unexplained renal or ureteral bleeding; make a specialist decision based on source control and drainage. For patients with hemophilia and renal bleeding, WFH guidance recommends against antifibrinolytics (consensus based); with pain or persistent gross hematuria, it advises monitoring for clots and urinary obstruction.[14][22] Case reports describe ureteral clot obstruction after oral TXA for urothelial bleeding and after TXA plus pseudoaneurysm angioembolization for delayed post-partial-nephrectomy hemorrhage.[20][21] This caution is different from asserting that every renal operation is an absolute contraindication: perioperative PCNL trials exist. The Lee review had renal-function documentation in only 28 patients, so it cannot establish a reliable “less than 1%” obstruction rate or rule out injury.[1][15]

Current US injection label: contraindications include active intravascular clotting, subarachnoid hemorrhage, hypersensitivity and neuraxial administration. The boxed warning highlights fatal errors from intrathecal or epidural injection: label syringes and verify the route. Seizure risk is higher with high doses or renal accumulation; 2 g/day is not a validated safety cutoff. Adjust for renal function and infuse at the product's specified rate to avoid hypotension. The label also advises avoiding concomitant prothrombotic agents (factor IX complex, anti-inhibitor coagulant concentrates, hormonal contraceptives). Ask about prior VTE, arterial thrombosis, seizure and hormonal contraceptive use before dosing, and involve anesthesia when any is present.[17]

The oral tablet is labeled only for cyclic heavy menstrual bleeding (1,300 mg three times daily for up to 5 days per cycle, lower doses when serum creatinine exceeds 1.4 mg/dL). Its label contraindicates concomitant combined hormonal contraceptives and active thromboembolic disease or a history or intrinsic risk of thrombosis, including retinal vein or artery occlusion, and warns of visual and ocular adverse reactions. Oral use for urologic bleeding is off-label.[17]

Cancer-surgery meta-analyses support possible reductions in bleeding or transfusion.[16]

Guideline Status and Reconstructive Relevance​

EAU 2026 urolithiasis guidance acknowledges evidence that perioperative TXA may reduce PCNL bleeding and transfusion.[13] The evidence is strongest for selected perioperative settings, with direct procedure-level findings taking precedence over broad extrapolation. In a placebo-controlled trial of 30 women with posthysterectomy prolapse undergoing total colpocleisis, with or without a midurethral sling (14 TXA, 16 placebo), 1 g IV TXA after induction yielded a 24-hour hemoglobin decline of 3.2 versus 2.6 g/dL (p = .41) and intraoperative blood loss of 340 versus 405 mL (p = .58); one TXA recipient was transfused.[23] For reconstructive and vaginal operations, weigh expected bleeding, renal function, thrombosis risk and urinary drainage with anesthesia. Local measures such as hydrodissection remain complementary.

See Also​

References​

1. Cleveland B, Norling B, Wang H, et al. Tranexamic acid for percutaneous nephrolithotomy. Cochrane Database Syst Rev. 2023;10:CD015122. doi:10.1002/14651858.CD015122.pub2

2. Vanderbruggen W, Brits T, Tilborghs S, Derickx K, De Wachter S. The effect of tranexamic acid on perioperative blood loss in transurethral resection of the prostate: a double-blind, randomized controlled trial. Prostate. 2023;83(16):1584–1590. doi:10.1002/pros.24616

3. Mannucci PM. Hemostatic drugs. N Engl J Med. 1998;339(4):245–253. doi:10.1056/NEJM199807233390407

4. Longo MA, Cavalheiro BT, de Oliveira Filho GR. Systematic review and meta-analyses of tranexamic acid use for bleeding reduction in prostate surgery. J Clin Anesth. 2018;48:32–38. doi:10.1016/j.jclinane.2018.04.014

5. Crescenti A, Borghi G, Bignami E, et al. Intraoperative use of tranexamic acid to reduce transfusion rate in patients undergoing radical retropubic prostatectomy: double blind, randomised, placebo controlled trial. BMJ. 2011;343:d5701. doi:10.1136/bmj.d5701

6. Breau RH, Lavallée LT, Cagiannos I, et al. Tranexamic acid during radical cystectomy: a randomized clinical trial. JAMA Surg. 2024;159(12):1355–1363. doi:10.1001/jamasurg.2024.4183

7. Egen L, Keller K, Menold HS, et al. Tranexamic acid reduces perioperative blood transfusions following open radical cystectomy — a propensity-score matched analysis. World J Urol. 2024;42(1):477. doi:10.1007/s00345-024-05168-x

8. Tikkinen KAO, Marcucci M, Halme ALE, et al. Safety and efficacy of tranexamic acid in urologic surgery: results from the international, randomized, placebo-controlled POISE-3 trial. Eur Urol. 2026. doi:10.1016/j.eururo.2026.03.019

9. Lin YH, Lee KC, Hsu CC, Chen KT. Efficacy and safety of intravenous tranexamic acid in urologic surgery: a systematic review and meta-analysis of randomized controlled trials. Medicine (Baltimore). 2023;102(25):e34146. doi:10.1097/MD.0000000000034146

10. Naseralallah L, Nasrallah D, Alsheikh R, Assami D, Boudaka R. Tranexamic acid for the management of hematuria: a systematic review. Urology. 2026;210:136–142. doi:10.1016/j.urology.2025.12.035

11. Moharamzadeh P, Ojaghihaghighi S, Amjadi M, Rahmani F, Farjamnia A. Effect of tranexamic acid on gross hematuria: a pilot randomized clinical trial study. Am J Emerg Med. 2017;35(12):1922–1925. doi:10.1016/j.ajem.2017.09.012

12. Fowler H, Law J, Tham SM, et al. Impact on blood loss and transfusion rates following administration of tranexamic acid in major oncological abdominal and pelvic surgery: a systematic review and meta-analysis. J Surg Oncol. 2022;126(3):609–621. doi:10.1002/jso.26900

13. EAU. Urolithiasis Guidelines, 2026: PCNL evidence summary. Current chapter.

14. Srivastava A, Brewer AK, Mauser-Bunschoten EP, et al. Guidelines for the management of hemophilia. Haemophilia. 2013;19(1):e1–e47. doi:10.1111/j.1365-2516.2012.02909.x

15. Lee SG, Fralick J, Wallis CJD, et al. Systematic review of hematuria and acute renal failure with tranexamic acid. Eur J Haematol. 2022;108(6):510–517. doi:10.1111/ejh.13762

16. Soliman A, Azim AAA, Elgarawany A, et al. Efficacy and safety of tranexamic acid in solid cancer surgeries: a systematic review and meta-analysis of randomized controlled trials with GRADE assessment. Ann Surg Oncol. 2026. doi:10.1245/s10434-026-19377-8

17. CYKLOKAPRON. US prescribing information (injection), label effective September 2025; tranexamic acid USP tablets, generic label effective September 2025 (openFDA). Pfizer injection label.

18. Devereaux PJ, Marcucci M, Painter TW, et al. Tranexamic acid in patients undergoing noncardiac surgery. N Engl J Med. 2022;386:1986–1997. doi:10.1056/NEJMoa2201171.

19. Houston BL, McIsaac DI, Breau RH, et al. Hospital policy of tranexamic acid to reduce transfusion in major noncardiac surgery. N Engl J Med. Published June 2026. doi:10.1056/NEJMoa2515820.

20. Maresca G, Royle J, Donaldson JF. Tranexamic acid-induced ureteric clot obstruction in a patient with urothelial cell carcinoma resulting in upper urinary tract perforation. BMJ Case Rep. 2022;15(1):. doi:10.1136/bcr-2021-247334

21. Manolitsis I, Gatsos S, Dimitropoulos K, et al. Upper urinary tract clot obstruction after delayed hemorrhage following partial nephrectomy: a possible association with tranexamic acid. Cureus. 2026;18(3):e106136. doi:10.7759/cureus.106136

22. Srivastava A, Santagostino E, Dougall A, et al. "WFH Guidelines for the Management of Hemophilia, 3rd edition." Haemophilia. 2020;26(Suppl 6):1–158. doi:10.1111/hae.14046

23. McDermott CD, Lovatsis D, Wang S, Huszti E, Wadsworth K. "Does Intravenous Tranexamic Acid Reduce Blood Loss at the Time of Total Colpocleisis? A Randomized Double-Blind Placebo-Controlled Trial." J Minim Invasive Gynecol. 2025;32(6):555–561. doi:10.1016/j.jmig.2025.01.005

24. Suartz CV, Lepine HL, Matalani CFA, et al. "The efficacy and safety of tranexamic acid use during radical cystectomy: A systematic review and meta-analysis." Can Urol Assoc J. 2026;20(1):E56–E62. doi:10.5489/cuaj.9266

25. Makabe PF, Cavalcante LFF, Yuamoto B, et al. "The effect of tranexamic acid in perioperative bleeding transfusion in radical cystectomy: a systematic review and meta-analysis." BMC Urol. 2026;26(1):147. doi:10.1186/s12894-026-02162-w

26. Oliveira AV, Sampaio ALN, Freitas GA, et al. "Tranexamic Acid in Men Undergoing Transurethral Resection of Prostate: An Updated Systematic Review and Meta-Analysis." Prostate. 2026;86(3):279–290. doi:10.1002/pros.70095