Tranexamic Acid During Cystectomy Trial (TACT)

NCT01869413 | Completed Phase 2 DMC

• 2 other identifiers: CIHR MOP-342559Control # 162042
• Study Type: interventional
• Target: 354
• Locations: 1 country
• Sites: 10

Brief Summary

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

Bladder Cancer

Keywords

urothelial cell carcinoma; transition cell carcinoma; bladder cancer; radical cystectomy; cystectomy; bladder removal; tranexamic acid; cyklokapron

Outcome Measures

Primary Outcomes (1)

• proportion of patients transfused at least one unit of packed red blood cell transfusion

  up to 30 days post-operative

Secondary Outcomes (8)

• total units of red blood cells transfused

  up to 30 days post-operative

• occurrence of postoperative bleeding requiring intervention

  up to 30 days post-operative

• occurrence of platelet transfusion

  up to 30 days post-operative

• total units of platelets transfused

  up to 30 days post-operative

• occurrence of plasma transfusion

  up to 30 days post-operative

Other Outcomes (2)

• occurrence of severe adverse events

  up to 30 days post-operative

• number of treatment failures

  up to 30 days post-operative

Study Arms (2)

Tranexamic Acid

EXPERIMENTAL

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.

Drug: Tranexamic Acid

Placebo control

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Tranexamic Acid DRUG

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).

Also known as: Cyklokapron (Pfizer)

Tranexamic Acid

Placebo DRUG

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.

Also known as: Normal Saline

Placebo control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Dalhousie University: collaborator
• McGill University Health Centre/Research Institute of the McGill University Health Centre: collaborator
• Centre hospitalier de l'Université de Montréal (CHUM): collaborator
• Laval University: collaborator
• University of Western Ontario, Canada: collaborator
• University Health Network, Toronto: collaborator

Study Sites (10)

Northern Alberta Urology Centre

Edmonton, Alberta, T6G 1Z1, Canada

Location

St. Boniface General Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

Location

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

London Health Sciences Complex (LHSC)

London, Ontario, N6A 4G5, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

McGill University Health Centre (MUHC)

Montreal, Quebec, H3A 1A1, Canada

Location

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, Canada

Location

Centre Hospitalier de l'Université de Québec (CHUQ)

Québec, G1R 3S1, Canada

Location

Related Publications (2)

• Breau 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 DERIVED

• Breau 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 DERIVED

Related Links

• Tranexamic Acid (Cyklokapron) Product Monograph

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Tranexamic Acid; Saline Solution

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Rodney H Breau, MD, FRCSC

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2013
• First Posted: June 5, 2013
• Study Start: June 1, 2013
• Primary Completion: January 1, 2021
• Study Completion: June 1, 2021
• Last Updated: October 4, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (10)