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Tranexamic Acid During Cystectomy Trial (TACT) (TACT)

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ClinicalTrials.gov Identifier: NCT01869413
Recruitment Status : Unknown
Verified October 2016 by Ottawa Hospital Research Institute.
Recruitment status was:  Recruiting
First Posted : June 5, 2013
Last Update Posted : November 18, 2016
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Dalhousie University
McGill University Health Center
Centre hospitalier de l'Université de Montréal (CHUM)
Laval University
University of Western Ontario, Canada
University Health Network, Toronto
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

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.


Condition or disease Intervention/treatment Phase
Bladder Cancer Drug: Tranexamic Acid Drug: Placebo Phase 2 Phase 3

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 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: A 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 study will recruit 354 patients 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 within 10 minutes (loading dose) and 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 primary research objective 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 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: 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 354 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Tranexamic Acid During Cystectomy Trial (TACT)
Study Start Date : June 2013
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arm Intervention/treatment
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.
Drug: 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).
Other Name: Cyklokapron (Pfizer)

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.
Drug: Placebo
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.
Other Name: Normal Saline




Primary Outcome Measures :
  1. proportion of patients transfused at least one unit of packed red blood cell transfusion [ Time Frame: up to 30 days post-operative ]

Secondary Outcome Measures :
  1. total units of red blood cells transfused [ Time Frame: up to 30 days post-operative ]
  2. occurrence of postoperative bleeding requiring intervention [ Time Frame: up to 30 days post-operative ]
    intervention noted as reoperation or angioinfarction

  3. occurrence of platelet transfusion [ Time Frame: up to 30 days post-operative ]
  4. total units of platelets transfused [ Time Frame: up to 30 days post-operative ]
  5. occurrence of plasma transfusion [ Time Frame: up to 30 days post-operative ]
  6. total units of plasma transfused [ Time Frame: up to 30 days post-operative ]
  7. estimated intra-operative blood loss [ Time Frame: up to 30 days post-operative ]
  8. change in hemoglobin [ Time Frame: up to 30 days post-operative ]

Other Outcome Measures:
  1. occurrence of severe adverse events [ Time Frame: up to 30 days post-operative ]
  2. number of treatment failures [ Time Frame: up to 30 days post-operative ]
    treatment failures noted as the need for anti-hemorrhagic rescue interventions such as topical agents (oxidized cellulose) and recombinant Factor VIIa



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01869413


Contacts
Contact: Rodney H Breau, MD, FRCSC 613-737-8899 ext 73019 rbreau@ottawahospital.on.ca
Contact: Louise Lebel, BScN 613-737-8899 ext 74639 llebel@ohri.ca

Locations
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Centre Active, not recruiting
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
St. Joseph's Healthcare Hamilton Recruiting
Hamilton, Ontario, Canada, L8N 4A6
Contact: Bobby Shayegan, MD    905-522-1155 ext 33982    shayeb@mcmaster.ca   
Principal Investigator: Bobby Shayegan, MD         
London Health Sciences Complex (LHSC) Active, not recruiting
London, Ontario, Canada, N6A 4G5
The Ottawa Hospital Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Rodney H Breau, MD, FRCSC    613-737-8899 ext 73019    rbreau@ottawahospital.on.ca   
Contact: Louise LeBel, BScN    613-737-8899 ext 74639    llebel@ohri.ca   
Principal Investigator: Rodney H Breau, MD         
University Health Network Recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Girish Kulkarni, MD    416-946-4501    girish.kulkarni@uhn.ca   
Principal Investigator: Girish Kulkarni, MD         
Canada, Quebec
McGill University Health Centre (MUHC) Active, not recruiting
Montréal, Quebec, Canada, H3A 1A1
Centre Hospitalier de l'Université de Montréal (CHUM) Active, not recruiting
Montréal, Quebec, Canada
Sponsors and Collaborators
Ottawa Hospital Research Institute
Canadian Institutes of Health Research (CIHR)
Dalhousie University
McGill University Health Center
Centre hospitalier de l'Université de Montréal (CHUM)
Laval University
University of Western Ontario, Canada
University Health Network, Toronto
Investigators
Principal Investigator: Rodney H Breau, MD, FRCSC Ottawa Hospital Research Institute

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT01869413     History of Changes
Other Study ID Numbers: CIHR MOP-342559
Control # 162042 ( Other Identifier: Health Canada )
First Posted: June 5, 2013    Key Record Dates
Last Update Posted: November 18, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Ottawa Hospital Research Institute:
urothelial cell carcinoma
transition cell carcinoma
bladder cancer
radical cystectomy
cystectomy
bladder removal
tranexamic acid
cyklokapron

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Tranexamic Acid
Antifibrinolytic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants