Tranexamic Acid During Cystectomy Trial (TACT)

Who is this study for? Adult patients with Bladder Cancer that plan to undergo radical cystectomy
What treatments are being studied? Transexamic Acid
Status: Completed
Location: See all (10) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Canada
Northern Alberta Urology Centre
Edmonton
Queen Elizabeth II Health Sciences Centre
Halifax
St. Joseph's Healthcare Hamilton
Hamilton
London Health Sciences Complex (LHSC)
London
Centre Hospitalier de l'Université de Montréal (CHUM)
Montréal
McGill University Health Centre (MUHC)
Montréal
The Ottawa Hospital
Ottawa
Centre Hospitalier de l'Université de Québec (CHUQ)
Québec
University Health Network
Toronto
St. Boniface General Hospital
Winnipeg
Time Frame
Start Date: 2013-06
Completion Date: 2021-06
Participants
Target number of participants: 354
Treatments
Experimental: Tranexamic Acid
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.
Placebo_comparator: Placebo control
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.
Related Therapeutic Areas
Sponsors
Collaborators: Canadian Institutes of Health Research (CIHR), Dalhousie University, McGill University Health Centre/Research Institute of the McGill University Health Centre, Laval University, University Health Network, Toronto, Centre hospitalier de l'Université de Montréal (CHUM), University of Western Ontario, Canada
Leads: Ottawa Hospital Research Institute

This content was sourced from clinicaltrials.gov