Chronic Kidney DiseasesPhase 3BRACKETSNCT06337838
Bleeding Reduction in Acute and Chronic Kidney Patients Having Surgery (BRACKETS) Pilot Trial
A Phase 3 study testing Desmopressin Injectable Solution and Tranexamic Acid Injectable Product in people with Chronic Kidney Diseases and Acute Kidney Injury, run by Hamilton Health Sciences Corporation at 3 sites in Canada.
Trial summary
The BRACKETS pilot study is a multicentre, prospective, randomized controlled trial of prophylactic preoperative tranexamic acid (TXA) versus placebo and, using a partial factorial design, of prophylactic preoperative desmopressin versus placebo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases, Acute Kidney Injury, Bleeding
- What is being tested?
- Desmopressin Injectable Solution and Tranexamic Acid Injectable Product
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 3 sitesCanada
- Study dates
- 9 Jun 2025to Jun 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- 1. Included in the TXA factorial.
Who cannot join
- Undergoing cardiac surgery;
- Undergoing intracranial neurosurgery;
- Undergoing surgery for creation or revision of arteriovenous fistula or graft for dialysis access;
- Planned use of prophylactic systemic TXA or ϵ-aminocaproic acid;
- Hypersensitivity or known allergy to TXA;
- History of seizure disorder;
Show all 16Show fewer
- Recent (within 90 days) stroke, myocardial infarction, acute arterial thrombosis, deep venous thrombosis, pulmonary embolism, or thrombosis of an arteriovenous fistula or graft;
- History of thrombotic thrombocytopenic purpura, atypical hemolytic uremic syndrome, or antiphospholipid antibody syndrome;
- Women who are known to be pregnant, breastfeeding, or who meet both of the following criteria: i) are of childbearing potential and do not have a negative pregnancy test documented in the 7 days before surgery, AND ii) are not using effective contraception; or
- Previously enrolled in the BRACKETS-Pilot Trial.
- Eligibility criteria specific to the desmopressin factorial component of trial
- The hospital does not have access to desmopressin;
- Planned use of prophylactic desmopressin;
- Most recent serum sodium concentration < 130 mEq/L;
- Known or suspected von Willebrand disease (any kind), hemophilia, or platelet function disorder; or
- Hypersensitivity or known allergy to desmopressin.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada3 sites, 2 recruiting
- Recruiting
London Health Sciences Centre
London, Ontario, N6A 5A5
Cadence Baker, 519-685-8500 ext. 34769, cadence.baker@lhsc.on.ca
Pavel Roshanov, MD
- Active, not recruiting
Centre Hospitalier de L'Universite de Montreal (CHUM)
Montreal, Quebec, H2X 0A9
- Recruiting
McGill University University Health Centre
Montreal, Quebec, H3H 2R9
Lin Jawhar
Shaifali Sandal, MD
About this study
Official title: Bleeding Reduction in Acute and Chronic KidnEy patienTs Having Surgery (BRACKETS) Pilot Trial
The BRACKETS pilot study is a multicentre, prospective, randomized controlled trial of prophylactic preoperative tranexamic acid (TXA) versus placebo and, using a partial factorial design, of prophylactic preoperative desmopressin versus placebo.
Read the detailed description
Perioperative administration of TXA reduces bleeding risk in surgical patients. However, large clinical trials have excluded patients with advanced kidney disease, so the benefits remain uncertain in this population, and there is potential for harm. The benefit of desmopressin, which is purported to more directly address the defect of primary hemostasis believed important in severe kidney disease more directly than TXA, has not been examined in adequate randomized control trials (RCTs). Both medications are generic and have been available for many years. To convincingly test these medications in patients with severe kidney disease, large, global trials are required. This pilot-phase trial will 1) inform the feasibility and design of a large international trial to evaluate the efficacy and safety of TXA and desmopressin in patients with advanced kidney disease undergoing noncardiac surgery, 2) provide preliminary data regarding the efficacy and safety of TXA and desmopressin in people with advanced kidney disease having noncardiac surgery, and 3) provide pharmacokinetic data to inform dose selection.
- Conditions
- Chronic Kidney Diseases, Acute Kidney Injury, Bleeding, Surgery
- Being tested
- Desmopressin Injectable Solution, Tranexamic Acid Injectable Product, Placebo
- Keywords
- Major Noncardiac Surgery, Tranexamic Acid, Desmopressin
- Medical subject headings
- Renal Insufficiency, Chronic, Acute Kidney Injury, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Desmopressin Injectable SolutionDrug
Also called DDAVP
Intravenous desmopressin, 20 mcg, single dose administration.
Tranexamic Acid Injectable ProductDrug
Also called Cyklokapron
Intravenous tranexamic acid, 1000 mg single dose administration for patients with eGFR<25 not yet receiving dialysis OR 500 mg single dose administration for patients receiving dialysis.
PlaceboOther
Intravenous 0.9% saline solution
| Study group | Role | What they receive |
|---|---|---|
| Prophylactic intravenous tranexamic acid and prophylactic intravenous desmopressin. | Experimental | Within 20 minutes preceding anticipated skin incision, patients will receive preoperative prophylactic intravenous tranexamic acid at a dose of 1000 mg infused over 10 minutes for patients with estimated glomerular filtration rate (eGFR) <25 ml/min/1.73m2 who do not receive dialysis before surgery and 500 mg infused over 10 minutes for patients who receive dialysis.
Within 20 minutes preceding anticipated skin incision, patients allocated to the desmopressin intervention group will receive intravenous desmopressin at a dose of 20 mcg over 30 minutes. Receives: Drug: Desmopressin Injectable Solution; Drug: Tranexamic Acid Injectable Product |
| Prophylactic intravenous tranexamic acid and placebo. | Experimental | Within 20 minutes preceding anticipated skin incision, patients will receive preoperative prophylactic intravenous tranexamic acid at a dose of 1000 mg infused over 10 minutes for patients with eGFR <25 ml/min/1.73m2 who do not receive dialysis before surgery and 500 mg infused over 10 minutes for patients who receive dialysis.
Within 20 minutes preceding anticipated skin incision, patients allocated to the desmopressin control group will receive an intravenous infusion of 0.9% saline solution, administered over a duration of 30 minutes. Receives: Drug: Tranexamic Acid Injectable Product; Other: Placebo |
| Prophylactic intravenous desmopressin and placebo. | Experimental | Within 20 minutes preceding anticipated skin incision, patients will receive intravenous desmopressin at a dose of 20 mcg over 30 minutes. Patients will not receive prophylactic tranexamic acid.
Within 20 minutes preceding anticipated skin incision, patients allocated to the tranexamic acid control group will receive an intravenous infusion of 0.9% saline solution. This saline solution will be administered over a duration of 10 minutes in a volume equivalent to that received by patients in the tranexamic acid intervention group. Receives: Drug: Desmopressin Injectable Solution; Other: Placebo |
| Placebo and placebo. | Placebo comparator | Within 20 minutes preceding anticipated skin incision, patients allocated to the tranexamic acid control group will receive an intravenous infusion of 0.9% saline solution. This saline solution will be administered over a duration of 10 minutes in a volume equivalent to that received by patients in the tranexamic acid intervention group.
Within 20 minutes preceding anticipated skin incision, patients allocated to the desmopressin control group will receive an intravenous infusion of 0.9% saline solution, administered over a duration of 30 minutes. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of recruitment
A rate of 0.25 patients per study site per week
Measured: Through study completion, an average of 1.5 years
Receipt of the allocated study drug within 1 hour before start of surgery for the tranexamic acid factorial
Account of whether the patient began to receive study drug for the TXA factorial within an hour before skin incision. Target ≥80% of participants
Measured: Day of surgery
Receipt of the allocated study drug within 1 hour before start of surgery for the desmopressin factorial
Account of whether the patient began to receive study drug for the desmopressin factorial within an hour before skin incision. Target ≥80% of participants
Measured: Day of surgery
Completion of 30-day follow-up
Account of whether the patient or their next-of-kin could be contacted and completed the 30-day post-randomization assessment. Target ≥80% of participants
Measured: 30 days after randomization
Secondary outcomes (46)
Bleeding Independently Associated with Mortality after noncardiac Surgery (BIMS)
Number of patients who experience BIMS
Measured: 30 days after randomization
Bleeding Score
10-category ordinal score. Minimum scores mean a better outcome. 0 denotes no bleeding or bleeding in which the nadir hemoglobin is ≥70 g/L, no red blood transfusion was given, no reoperation for reasons of bleeding occurred, and there was no death imminently or directly caused by bleeding.
- denotes bleeding and post-operative hemoglobin <70 g/L or 1 unit of blood (red blood cells or whole blood) transfused.
- denotes bleeding and 2 units transfused.
- denotes bleeding and 3 units transfused.
- denotes bleeding and 4 units transfused
- denotes bleeding and 5 units transfused.
- denotes bleeding and 6 units transfused.
- denotes bleeding and 7 units transfused.
- denotes bleeding and 8 or more units of blood transfused.
- denotes reoperation for reasons of bleeding.
- denotes death imminently or directly caused by bleeding.
Measured: 30 days after randomization
Reoperation for reasons of bleeding
Number of patients who return to the operating room for surgical management of suspected documented bleeding
Measured: 30 days after randomization
Blood (red blood cells or whole blood) transfused
Number of units of blood transfused.
Measured: 30 days after randomization
Blood (red blood cells or whole blood) transfused
Number of units of blood transfused.
Measured: Up to and including postoperative day 3 after surgery
Any blood transfusion (red blood cells or whole blood)
Number of units of blood transfused.
Measured: 30 days after randomization
Any blood transfusion (red blood cells or whole blood)
Number of units of blood transfused.
Measured: Up to and including postoperative day 3
Lowest measured hemoglobin concentration
The mean absolute difference for continuous outcomes using linear regression with treatment allocation
Measured: 30 days after randomization
Most recent hemoglobin concentration
The mean absolute difference for continuous outcomes using linear regression with treatment allocation
Measured: 30 days after randomization
Death
Number of patients who die of any cause
Measured: 30 days after randomization
Major arterial and venous thrombosis
(i.e., composite of myocardial injury after noncardiac surgery [MINS], stroke, peripheral arterial thrombosis, dialysis vascular access thrombosis requiring anticoagulation or intervention, and symptomatic venous thromboembolism)
Measured: 30 days after randomization
Myocardial Injury after Noncardiac Surgery (MINS)
Number of patients who experience MINS
Measured: 30 days after randomization
Myocardial Injury after Noncardiac Surgery (MINS) that meets criteria for myocardial infarction
Number of patients who experience MINS that meets criteria for myocardial infarction (based on the Fourth Universal Definition of myocardial infarction)
Measured: 30 days after randomization
MINS that is an isolated ischemic troponin elevation
Number of patients who experience MINS that is an isolated ischemic troponin elevation
Measured: 30 days after randomization
Stroke
Number of patients experiencing a stroke
Measured: 30 days after randomization
Non-hemorrhagic stroke
Number of patients who experience a non-hemorrhagic stroke
Measured: 30 days after randomization
Hemorrhagic stroke
Number of patients who experience a hemorrhagic stroke
Measured: 30 days after randomization
Peripheral arterial thrombosis
Number of patients who experience a peripheral arterial thrombosis
Measured: 30 days after randomization
Thrombosis of arteriovenous fistula or graft
Number of patients who have thrombosis of arteriovenous fistula or graft
Measured: 30 days after randomization
Symptomatic proximal venous thromboembolism
Number of patients who experience symptomatic proximal venous thromboembolism
Measured: 30 days after randomization
Symptomatic pulmonary embolism
Number of patients who experience a symptomatic pulmonary embolism
Measured: 30 days after randomization
Symptomatic proximal leg or arm deep venous thrombosis (DVT)
Number of patients who experience a symptomatic proximal leg or arm DVT
Measured: 30 days after randomization
Non-fatal cardiac arrest
Number of patients who experience non-fatal cardiac arrest
Measured: 30 days after randomization
Coronary revascularization procedure
Number of patients who undergo coronary revascularization procedure
Measured: 30 days after randomization
Clinically important atrial fibrillation or flutter
Number of patients who experience clinically important atrial fibrillation or flutter
Measured: 30 days after randomization
Acute heart failure or clinically important volume overload
Number of patients who experience acute heart failure or clinically important volume overload.
Measured: 30 days after randomization
Acute kidney injury (for patients not receiving dialysis before surgery)
Number of patients who experience an acute kidney injury
Measured: 30 days after randomization
New start of dialysis
Number of patients who require new start of dialysis
Measured: 30 days after randomization
Seizure
Number of patients who experience a seizure
Measured: 30 days after randomization
Clinically significant intraoperative hypotension
Number of patients who experience clinically significant intraoperative hypotension
Measured: 30 days after randomization
Clinically significant postoperative hypotension
Number of patients who experience clinically significant postoperative hypotension
Measured: Up to and including the end of postoperative day 1
Sepsis
Number of patients who experience sepsis
Measured: 30 days after randomization
Duration of surgery
The time from skin incision to closure, in minutes.
Measured: 30 days after randomization
Receipt of platelets
Any transfusion of this blood product
Measured: 30 days after randomization
Receipt of fibrinogen
Any transfusion of this blood product
Measured: 30 days after randomization
Receipt of fresh frozen plasma
Any transfusion of this blood product
Measured: 30 days after randomization
Receipt of cryoprecipitate
Any transfusion of this blood product
Measured: 30 days after randomization
Receipt of recombinant Factor VIIa
Number of patients receiving recombinant factor VIIa
Measured: 30 days after randomization
Receipt of prothrombin complex concentrate
Number of patients who receive prothrombin complex concentrate
Measured: 30 days after randomization
Prescribed erythropoiesis stimulating agent
Number of patients receiving a weekly dose of erythropoiesis stimulating agent on prescription active at 30 days
Measured: 30 days after randomization
Severe hyponatremia
Measured serum sodium concentration <125 meq/L
Measured: Up to and including the end of postoperative day 1
Duration of hospital stay after surgery
Cumulative number of nights spent in an acute care hospital
Measured: Day of surgery and ending the day of discharge
Duration of critical care stay after surgery
Cumulative number of nights spent in an intensive care unit
Measured: Day of surgery and ending the day of discharge
Delayed graft function after kidney transplantation
Receipt of dialysis
Measured: Within 7 days following kidney transplantation
Persistent dialysis dependence
Participant continues to receive dialysis after surgery.
Measured: 30 days after randomization
Incisional site pain severity
Rating of pain using the 10-point ordinal scale where 0 corresponds to no pain and 10 corresponds to the worst pain imaginable.
Measured: 30 days after randomization in the last 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study start9 Jun 2025
- Primary completionFeb 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 2x2 partial factorial design where patients are first randomized to receive prophylactic intravenous TXA versus placebo, and (when the study drug is available) to be randomized to receive prophylactic intravenous desmopressin versus placebo before noncardiac surgery.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Population Health Research Institute
- Responsible party
- Sponsor
- Investigators
- Pavel Roshanov, MC,MSc,FRCPC, Principal investigator, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06337838
- Sponsor's protocol ID
- 2024.BRACKETS-Pilot
- Acronym
- BRACKETS
- Status last verified
- May 2026
- First submitted
- 22 Jan 2024
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bleeding Reduction in Acute and Chronic KidnEy patienTs Having Surgery (BRACKETS) Pilot Trial
- ClinicalTrials.gov ID
- NCT06337838
- Acronym / sponsor ID
- BRACKETS / 2024.BRACKETS-Pilot
- Conditions
- Chronic Kidney Diseases, Acute Kidney Injury, Bleeding, Surgery
- Keywords
- Major Noncardiac Surgery, Tranexamic Acid, Desmopressin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Collaborators
- Population Health Research Institute
- Study start
- 9 Jun 2025 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 29 Mar 2024 (actual)
- 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.
The BRACKETS pilot study is a multicentre, prospective, randomized controlled trial of prophylactic preoperative tranexamic acid (TXA) versus placebo and, using a partial factorial design, of prophylactic preoperative desmopressin versus placebo.
Detailed description
Perioperative administration of TXA reduces bleeding risk in surgical patients. However, large clinical trials have excluded patients with advanced kidney disease, so the benefits remain uncertain in this population, and there is potential for harm. The benefit of desmopressin, which is purported to more directly address the defect of primary hemostasis believed important in severe kidney disease more directly than TXA, has not been examined in adequate randomized control trials (RCTs). Both medications are generic and have been available for many years. To convincingly test these medications in patients with severe kidney disease, large, global trials are required. This pilot-phase trial will 1) inform the feasibility and design of a large international trial to evaluate the efficacy and safety of TXA and desmopressin in patients with advanced kidney disease undergoing noncardiac surgery, 2) provide preliminary data regarding the efficacy and safety of TXA and desmopressin in people with advanced kidney disease having noncardiac surgery, and 3) provide pharmacokinetic data to inform dose selection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- 2x2 partial factorial design where patients are first randomized to receive prophylactic intravenous TXA versus placebo, and (when the study drug is available) to be randomized to receive prophylactic intravenous desmopressin versus placebo before noncardiac surgery.
| Arm | Type | Receives |
|---|---|---|
| Prophylactic intravenous tranexamic acid and prophylactic intravenous desmopressin. | Experimental | Drug: Desmopressin Injectable Solution, Drug: Tranexamic Acid Injectable ProductWithin 20 minutes preceding anticipated skin incision, patients will receive preoperative prophylactic intravenous tranexamic acid at a dose of 1000 mg infused over 10 minutes for patients with estimated glomerular filtration rate (eGFR) <25 ml/min/1.73m2 who do not receive dialysis before surgery and 500 mg infused over 10 minutes for patients who receive dialysis. Within 20 minutes preceding anticipated skin incision, patients allocated to the desmopressin intervention group will receive intravenous desmopressin at a dose of 20 mcg over 30 minutes. |
| Prophylactic intravenous tranexamic acid and placebo. | Experimental | Drug: Tranexamic Acid Injectable Product, Other: PlaceboWithin 20 minutes preceding anticipated skin incision, patients will receive preoperative prophylactic intravenous tranexamic acid at a dose of 1000 mg infused over 10 minutes for patients with eGFR <25 ml/min/1.73m2 who do not receive dialysis before surgery and 500 mg infused over 10 minutes for patients who receive dialysis. Within 20 minutes preceding anticipated skin incision, patients allocated to the desmopressin control group will receive an intravenous infusion of 0.9% saline solution, administered over a duration of 30 minutes. |
| Prophylactic intravenous desmopressin and placebo. | Experimental | Drug: Desmopressin Injectable Solution, Other: PlaceboWithin 20 minutes preceding anticipated skin incision, patients will receive intravenous desmopressin at a dose of 20 mcg over 30 minutes. Patients will not receive prophylactic tranexamic acid. Within 20 minutes preceding anticipated skin incision, patients allocated to the tranexamic acid control group will receive an intravenous infusion of 0.9% saline solution. This saline solution will be administered over a duration of 10 minutes in a volume equivalent to that received by patients in the tranexamic acid intervention group. |
| Placebo and placebo. | Placebo comparator | Other: PlaceboWithin 20 minutes preceding anticipated skin incision, patients allocated to the tranexamic acid control group will receive an intravenous infusion of 0.9% saline solution. This saline solution will be administered over a duration of 10 minutes in a volume equivalent to that received by patients in the tranexamic acid intervention group. Within 20 minutes preceding anticipated skin incision, patients allocated to the desmopressin control group will receive an intravenous infusion of 0.9% saline solution, administered over a duration of 30 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Included in the TXA factorial.
Key exclusion criteria (16 listed)
- Undergoing cardiac surgery;
- Undergoing intracranial neurosurgery;
- Undergoing surgery for creation or revision of arteriovenous fistula or graft for dialysis access;
- Planned use of prophylactic systemic TXA or ϵ-aminocaproic acid;
- Hypersensitivity or known allergy to TXA;
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 |
|---|---|---|
| Desmopressin Injectable SolutionAlso: DDAVPIntravenous desmopressin, 20 mcg, single dose administration. | Drug | Prophylactic intravenous desmopressin and placebo., Prophylactic intravenous tranexamic acid and prophylactic intravenous desmopressin. |
| Tranexamic Acid Injectable ProductAlso: CyklokapronIntravenous tranexamic acid, 1000 mg single dose administration for patients with eGFR<25 not yet receiving dialysis OR 500 mg single dose administration for patients receiving dialysis. | Drug | Prophylactic intravenous tranexamic acid and placebo., Prophylactic intravenous tranexamic acid and prophylactic intravenous desmopressin. |
| PlaceboIntravenous 0.9% saline solution | Other | Placebo and placebo., Prophylactic intravenous desmopressin and placebo., Prophylactic intravenous tranexamic acid and placebo. |
Primary outcome
Rate of recruitment
Time frame: Through study completion, an average of 1.5 years
A rate of 0.25 patients per study site per week
Receipt of the allocated study drug within 1 hour before start of surgery for the tranexamic acid factorial
Time frame: Day of surgery
Account of whether the patient began to receive study drug for the TXA factorial within an hour before skin incision. Target ≥80% of participants
Receipt of the allocated study drug within 1 hour before start of surgery for the desmopressin factorial
Time frame: Day of surgery
Account of whether the patient began to receive study drug for the desmopressin factorial within an hour before skin incision. Target ≥80% of participants
Completion of 30-day follow-up
Time frame: 30 days after randomization
Account of whether the patient or their next-of-kin could be contacted and completed the 30-day post-randomization assessment. Target ≥80% of participants
46 secondary outcomes
Bleeding Independently Associated with Mortality after noncardiac Surgery (BIMS)
Time frame: 30 days after randomization
Bleeding Score
Time frame: 30 days after randomization
Reoperation for reasons of bleeding
Time frame: 30 days after randomization
Blood (red blood cells or whole blood) transfused
Time frame: 30 days after randomization
Blood (red blood cells or whole blood) transfused
Time frame: Up to and including postoperative day 3 after surgery
Any blood transfusion (red blood cells or whole blood)
Time frame: 30 days after randomization
Any blood transfusion (red blood cells or whole blood)
Time frame: Up to and including postoperative day 3
Lowest measured hemoglobin concentration
Time frame: 30 days after randomization
Most recent hemoglobin concentration
Time frame: 30 days after randomization
Death
Time frame: 30 days after randomization
Major arterial and venous thrombosis
Time frame: 30 days after randomization
Myocardial Injury after Noncardiac Surgery (MINS)
Time frame: 30 days after randomization
Myocardial Injury after Noncardiac Surgery (MINS) that meets criteria for myocardial infarction
Time frame: 30 days after randomization
MINS that is an isolated ischemic troponin elevation
Time frame: 30 days after randomization
Stroke
Time frame: 30 days after randomization
Non-hemorrhagic stroke
Time frame: 30 days after randomization
Hemorrhagic stroke
Time frame: 30 days after randomization
Peripheral arterial thrombosis
Time frame: 30 days after randomization
Thrombosis of arteriovenous fistula or graft
Time frame: 30 days after randomization
Symptomatic proximal venous thromboembolism
Time frame: 30 days after randomization
Symptomatic pulmonary embolism
Time frame: 30 days after randomization
Symptomatic proximal leg or arm deep venous thrombosis (DVT)
Time frame: 30 days after randomization
Non-fatal cardiac arrest
Time frame: 30 days after randomization
Coronary revascularization procedure
Time frame: 30 days after randomization
Clinically important atrial fibrillation or flutter
Time frame: 30 days after randomization
Acute heart failure or clinically important volume overload
Time frame: 30 days after randomization
Acute kidney injury (for patients not receiving dialysis before surgery)
Time frame: 30 days after randomization
New start of dialysis
Time frame: 30 days after randomization
Seizure
Time frame: 30 days after randomization
Clinically significant intraoperative hypotension
Time frame: 30 days after randomization
Clinically significant postoperative hypotension
Time frame: Up to and including the end of postoperative day 1
Sepsis
Time frame: 30 days after randomization
Duration of surgery
Time frame: 30 days after randomization
Receipt of platelets
Time frame: 30 days after randomization
Receipt of fibrinogen
Time frame: 30 days after randomization
Receipt of fresh frozen plasma
Time frame: 30 days after randomization
Receipt of cryoprecipitate
Time frame: 30 days after randomization
Receipt of recombinant Factor VIIa
Time frame: 30 days after randomization
Receipt of prothrombin complex concentrate
Time frame: 30 days after randomization
Prescribed erythropoiesis stimulating agent
Time frame: 30 days after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- 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.
Pavel Roshanov, MC,MSc,FRCPC principal investigator
Western University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Desmopressin Injectable Solution and Tranexamic Acid Injectable Product in people with Chronic Kidney Diseases and Acute Kidney Injury, run by Hamilton Health Sciences Corporation at 3 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 1 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 phase mean?
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ingrid Copland (905-296-5754, brackets@phri.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of recruitment (time frame: Through study completion, an average of 1.5 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2026.