Bleeding Reduction in Acute and Chronic Kidney Patients Having Surgery (BRACKETS) Pilot Trial
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorHamilton Health Sciences Corporation
About this 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.
Eligibility criteria
Qualifiers
Planned noncardiac surgery (elective, urgent, or emergency surgery);
Expected to require at least an overnight hospital admission after surgery;
Age ≥18 years; and
Informed consent is obtained to participate in the BRACKETS-Pilot Trial.
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Desmopressin Injectable Solution
- Tranexamic Acid Injectable Product
- Placebo
Treatment groups
100 Participants
are divided into 4 treatment groupsLocations
3London Health Sciences CentreN6A 5A5, LondonOntario, Canada
Centre Hospitalier de L'Universite de Montreal (CHUM)H2X 0A9, MontrealQuebec, Canada
McGill University University Health CentreH3H 2R9, MontrealQuebec, Canada
Sponsors and collaborators
Hamilton Health Sciences Corporation
Lead sponsor
Population Health Research Institute
Collaborator
Source ClinicalTrials.gov