Tranexamic Acid During Cystectomy Trial (TACT) Pilot Study
Conditions
Bladder Cancer
Conditions: official terms
Urinary Bladder Neoplasms
Conditions: Keywords
urothelial cell carcinoma, transition cell carcinoma, bladder cancer, radical cystectomy, cystectomy, bladder removal, tranexamic acid, cyklokapron
Study Type
Interventional
Study Phase
Phase 2/Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Intervention
Name: Tranexamic Acid Type: Drug
Name: Placebo Type: Drug
Overall Status
Recruiting
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.
Detailed Description
Removal of the bladder and adjacent organs in patients with bladder cancer (radical cystectomy) often results in significant blood loss, and approximately 60% of patients require peri-operative blood transfusion. Reducing blood loss and the frequency of transfusion offers several benefits, including donor blood conservation, health care cost reduction, and avoidance of blood product exposure. Tranexamic acid is an amino acid lysine derivative with strong antifibrinolytic clotting properties that can be administered systemically. This medication has been used in a variety of operative procedures, notably in high risk cardiac surgery, to decrease peri-operative blood loss, and it is associated with an acceptable risk of adverse events. Systemic anti-hemorrhagics are infrequently used during radical cystectomy, and to the investigators knowledge their effects have not been evaluated in a clinical trial.

Overall objective: To conduct an internal pilot study to determine feasibility of a randomized controlled trial of systemic tranexamic acid compared to placebo in reducing the number of blood transfusions in patients undergoing radical cystectomy for bladder cancer.

Design: An internal pilot study, employing the protocol of the full multi-center, randomized, double-blinded, placebo controlled trial.

Study population: Consenting patients 18 years of age and older undergoing a radical cystectomy for bladder cancer, excluding those who: are unwilling to receive blood products due to personal reasons, are pregnant, have active angina, have a known allergy to tranexamic acid, or have a known personal history of deep venous thrombosis, atrial fibrillation, coronary stent, sub-arachnoid hemorrhage, pulmonary embolism, thrombotic stroke and / or acquired disturbance of colour vision. The pilot study will recruit the first 55 patients of 354 patients required for the full study from Dalhousie University, McGill University, Université de Montreal, Université Laval, University of Ottawa, University of Western Ontario and University of Alberta.

Intervention:

Tranexamic Acid arm: Tranexamic acid will be administered as an intravenous infusion of 10 mg/kg over 10 minutes (loading dose) before 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/hour infusion for the duration of surgery. For a 6 hour procedure, the total dose administered would be 3200 mg.

Placebo arm: As there is no standard of care concerning administration of antifibrinolytic agents in cystectomy procedures, controls will follow the same dosing and schedule described above, but with 0.9% saline infusion.

Outcomes: The principal research questions for the investigators internal pilot (current application) pertain to feasibility of enrollment of cystectomy patients using the full RCT protocol of tranexamic acid vs. placebo. The pilot will address feasibility of site-specific enrollment, feasibility of multiple site start-ups, and feasibility of institutional ethics approval, protocol administration, and multicenter coordination.

The primary research objective for the investigators full RCT is whether the use of systemic tranexamic acid compared to placebo reduces the proportion of radical cystectomy patients requiring red blood cell transfusion up to 30 days post-operative (from a 50% transfusion rate with placebo to 35% with tranexamic acid). Secondary questions for the investigators full trial are: Will use of systemic tranexamic acid compared to placebo result in reductions in: i) intraoperative blood loss, ii) amounts of transfused blood products, and iii) post-operative complications? The safety (thrombotic events) of tranexamic acid will also be evaluated.

Importance of this study: A successful pilot will encourage us to continue with the full RCT that will determine whether tranexamic acid reduces blood loss and subsequent transfusions during radical cystectomy. If tranexamic acid reduces the number of blood transfusions, there will be an immediate impact to cystectomy patients, and surgeons may consider the routine use of systemic tranexamic acid during similar abdomino-pelvic procedures associated with significant blood loss.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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 ever had a pulmonary embolism, deep venous thrombosis, thrombotic stroke, atrial fibrillation, coronary stents or has active angina

- 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
Locations
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada
Status: Recruiting
Contact: Ricardo Rendon, MD, FRCSC - (902) 473-6570 - rrendon@dal.ca
London Health Sciences Complex (LHSC)
London, Ontario, Canada
Status: Recruiting
Contact: Jonathan Izawa, MD, FRCSC - 519-685-8550 - Jonathan.Izawa@lhsc.on.ca
The Ottawa Hospital
Ottawa, Ontario, Canada
Status: Recruiting
Contact: Rodney H Breau, MD, FRCSC - 613-737-8899 - rbreau@ottawahospital.on.ca
University Health Network
Toronto, Ontario, Canada
Status: Not yet recruiting
Contact: Girish Kulkarni, MD - 416-946-4501 - girish.kulkarni@uhn.ca
Centre Hospitalier de l'Université de Montréal (CHUM)
Montréal, Quebec, Canada
Status: Recruiting
Contact: Fred Saad, MD, FRCSC - 514-890-8000 - fredsaad@videotron.ca
McGill University Health Centre (MUHC)
Montréal, Quebec, Canada
Status: Recruiting
Contact: Wassim Kassouf, MD, FRCSC - 514-934-8246 - wassim.kassouf@muhc.mcgill.ca
Start Date
June 2013
Completion Date
January 2015
Sponsors
Ottawa Hospital Research Institute
Source
Ottawa Hospital Research Institute
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page