Tranexamic Acid During Cystectomy Trial (TACT)

• Status: Active, not recruiting
• Trial end date: 2021-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ottawa Hospital Research Institute
• Collaborators: Canadian Institutes of Health Research (CIHR); Centre hospitalier de l'Université de Montréal (CHUM); Dalhousie University; Laval University; McGill University Health Center; McGill University Health Centre/Research Institute of the McGill University Health Centre; University Health Network, Toronto; University of Western Ontario, Canada
• Treatments: Antifibrinolytic Agents; Fibrinolytic Agents; Tranexamic Acid

Criteria

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