Bladder CancerPhase 2/3TACTNCT01869413
Tranexamic Acid During Cystectomy Trial (TACT)
A Phase 2/3 study testing Tranexamic Acid in people with Bladder Cancer, run by Ottawa Hospital Research Institute at 10 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Tranexamic Acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 354 participants
- Where
- 10 sitesCanada
- Study dates
- Jun 2013to Jun 2021
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 9Show fewer
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Canada10 sites
Northern Alberta Urology Centre
Edmonton, Alberta, T6G 1Z1
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, B3H 2Y9
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 4A6
London Health Sciences Complex (LHSC)
London, Ontario, N6A 4G5
McGill University Health Centre (MUHC)
Montreal, Quebec, H3A 1A1
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6
Centre Hospitalier de l'Université de Québec (CHUQ)
Québec, G1R 3S1
University Health Network
Toronto, Ontario, M5G 2C4
St. Boniface General Hospital
Winnipeg, Manitoba, R2H 2A6
About this study
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.
Read the 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.
- Conditions
- Bladder Cancer
- Being tested
- Tranexamic Acid, Placebo
- Keywords
- urothelial cell carcinoma, transition cell carcinoma, bladder cancer, radical cystectomy, cystectomy, bladder removal, tranexamic acid, cyklokapron
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
Also called Cyklokapron (Pfizer)
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).
PlaceboDrug
Also called Normal Saline
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of patients transfused at least one unit of packed red blood cell transfusion
Measured: up to 30 days post-operative
Secondary outcomes (8)
total units of red blood cells transfused
Measured: up to 30 days post-operative
occurrence of postoperative bleeding requiring intervention
intervention noted as reoperation or angioinfarction
Measured: up to 30 days post-operative
occurrence of platelet transfusion
Measured: up to 30 days post-operative
total units of platelets transfused
Measured: up to 30 days post-operative
occurrence of plasma transfusion
Measured: up to 30 days post-operative
total units of plasma transfused
Measured: up to 30 days post-operative
estimated intra-operative blood loss
Measured: up to 30 days post-operative
change in hemoglobin
Measured: up to 30 days post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionJan 2021
- Study completionJun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 354 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Dalhousie University, McGill University Health Centre/Research Institute of the McGill University Health Centre, Centre hospitalier de l'Université de Montréal (CHUM), Laval University, University of Western Ontario, Canada, University Health Network, Toronto
- Responsible party
- Sponsor
- Investigators
- Rodney H Breau, MD, FRCSC, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01869413
- Sponsor's protocol ID
- CIHR MOP-342559
- Other IDs
- Control # 162042
- Acronym
- TACT
- Status last verified
- Oct 2022
- First submitted
- 31 May 2013
- Last updated
- 4 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 39356537Breau 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.
PubMed 29716640
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tranexamic Acid During Cystectomy Trial (TACT)
- ClinicalTrials.gov ID
- NCT01869413
- Acronym / sponsor ID
- TACT / CIHR MOP-342559
- Conditions
- Bladder Cancer
- Keywords
- urothelial cell carcinoma, transition cell carcinoma, bladder cancer, radical cystectomy, cystectomy, bladder removal, tranexamic acid, cyklokapron
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 354 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Dalhousie University, McGill University Health Centre/Research Institute of the McGill University Health Centre, Centre hospitalier de l'Université de Montréal (CHUM), Laval University, University of Western Ontario, Canada, University Health Network, Toronto
- Study start
- Jun 2013
- Primary completion
- Jan 2021 (actual)
- Study completion
- Jun 2021 (actual)
- First posted
- 5 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tranexamic Acid | Experimental | Drug: Tranexamic AcidTranexamic 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 control | Placebo comparator | Drug: PlaceboAs 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic AcidAlso: Cyklokapron (Pfizer)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). | Drug | Tranexamic Acid |
| PlaceboAlso: Normal SalineAs 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 control |
Primary outcome
proportion of patients transfused at least one unit of packed red blood cell transfusion
Time frame: up to 30 days post-operative
8 secondary outcomes
total units of red blood cells transfused
Time frame: up to 30 days post-operative
occurrence of postoperative bleeding requiring intervention
Time frame: up to 30 days post-operative
occurrence of platelet transfusion
Time frame: up to 30 days post-operative
total units of platelets transfused
Time frame: up to 30 days post-operative
occurrence of plasma transfusion
Time frame: up to 30 days post-operative
total units of plasma transfused
Time frame: up to 30 days post-operative
estimated intra-operative blood loss
Time frame: up to 30 days post-operative
change in hemoglobin
Time frame: up to 30 days post-operative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2022.
- Derived from this study: PubMed 39356537Breau 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.
- Derived from this study: PubMed 29716640Breau 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.
- Tranexamic Acid (Cyklokapron) Product MonographLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rodney H Breau, MD, FRCSC principal investigator
Ottawa Hospital Research Institute
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Tranexamic Acid in people with Bladder Cancer, run by Ottawa Hospital Research Institute at 10 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proportion of patients transfused at least one unit of packed red blood cell transfusion (time frame: up to 30 days post-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01869413, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2022.