Clinical trial · Interventional
Tranexamic Acid During Cystectomy Trial (TACT)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A cystectomy is the removal of the bladder and adjacent organs in patients with bladder cancer. This often results in significant blood loss, and about 60% of patients will require a blood transfusion during or up to 30 days after surgery. Significant blood loss may result in cardiovascular morbidity, and the use of blood products are expensive and expose patients to risk. Tranexamic acid reduces breakdown of hemostatic blood clots and it has therapeutic benefit when used in other surgical procedures to reduce blood loss and the need for transfusion. The current study will be the first to evaluate whether tranexamic acid is effective and safe to use during radical cystectomy. The results of the study will have an immediate impact on patient care.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Drug | — | UNRESOLVED |
| Tranexamic Acid | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Tranexamic Acid
- description
- Tranexamic acid will be administered as an intravenous infusion of 10 mg/kg over 10 minutes (loading dose) prior to surgical incision, followed by 5 mg/kg/hour continuous maintenance infusion for the length of surgery (typically 4 to 8 hours). For example, an 80 kg patient would receive 800 mg prior to incision and a 400 mg/hr infusion for the duration of surgery. For a 6 hour procedure, the total dose administered would be 3200 mg.
- interventionNames
- Drug: Tranexamic Acid
- type
- PLACEBO_COMPARATOR
- label
- Placebo control
- description
- As there is no standard of care concerning administration of anti-fibrinolytic agents in cystectomy procedures, controls will follow the same dosing and schedule as above (loading dose followed by maintenance infusion), but with 0.9% sodium chloride.
- interventionNames
- Drug: Placebo
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Participant ≥ 18 years at time of consent * Participant has bladder cancer and will undergo radical cystectomy to remove bladder * Participant is willing to receive blood products (i.e. packed red blood cells, platelets, plasma) * Have obtained Informed Consent Exclusion Criteria: * Participant declines consent * Participants incapable (incompetent) of providing Informed Consent * Participant is under 18 years * Participant is unwilling to receive blood products due to personal reasons * Participant has thromboembolic disease (active or diagnosed within 1 year) such as deep vein thrombosis, pulmonary embolism or cerebral thrombosis) * Participant with known personal history of subarachnoid haemorrhage. * Participant has acquired disturbances to his / her colour vision (does not apply to congenital colour blindness) * Participant is pregnant (confirmed by βHCG test) * Participant has a known allergy to tranexamic acid
References
Publications (2)
- DERIVEDBreau RH, Lavallee LT, Cagiannos I, Momoli F, Bryson GL, Kanji S, Morash C, Turgeon AF, Zarychanski R, Houston BL, McIsaac DI, Mallick R, Knoll GA, Kulkarni G, Izawa J, Saad F, Kassouf W, Fradet V, Rendon R, Shayegan B, Fairey A, Drachenberg DE, Fergusson D. Tranexamic Acid During Radical Cystectomy: A Randomized Clinical Trial. JAMA Surg. 2024 Dec 1;159(12):1355-1363. doi: 10.1001/jamasurg.2024.4183. PMID 39356537
- DERIVEDBreau RH, Lavallee LT, Cnossen S, Witiuk K, Cagiannos I, Momoli F, Bryson G, Kanji S, Morash C, Turgeon A, Zarychanski R, Mallick R, Knoll G, Fergusson DA. Tranexamic Acid versus Placebo to Prevent Blood Transfusion during Radical Cystectomy for Bladder Cancer (TACT): Study Protocol for a Randomized Controlled Trial. Trials. 2018 May 2;19(1):261. doi: 10.1186/s13063-018-2626-3. PMID 29716640