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Recruiting NCT06337838

Bleeding Reduction in Acute and Chronic Kidney Patients Having Surgery (BRACKETS) Pilot Trial

Phase III Interventional Chronic Kidney Diseases Acute Kidney Injury Bleeding Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Desmopressin Injectable Solution, Tranexamic Acid Injectable Product, Placebo.
Who it may be relevant to
Registry conditions: Chronic Kidney Diseases, Acute Kidney Injury, Bleeding, Surgery. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Bleeding Reduction in Acute and Chronic KidnEy patienTs Having Surgery (BRACKETS) Pilot Trial

Overview

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.

Interventions

  • Drug Desmopressin Injectable Solution
    Intravenous desmopressin, 20 mcg, single dose administration.
  • Drug Tranexamic Acid Injectable Product
    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.
  • Other Placebo
    Intravenous 0.9% saline solution

Primary outcome measures

  • Rate of recruitment [Time frame: 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 [Time frame: Day of surgery]
  • Receipt of the allocated study drug within 1 hour before start of surgery for the desmopressin factorial [Time frame: Day of surgery]
  • Completion of 30-day follow-up [Time frame: 30 days after randomization]
Secondary outcome measures (12)
  • 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]

Eligibility criteria

Eligibility criteria specific to the tranexamic acid (TXA) factorial component of trial Inclusion Criteria:

  • One of either:

1.1. eGFR <25 ml/min/1.73m2 estimated using the CKD-Epi 2009 or 2021creatinine-based equation from the most recent serum creatinine measurement done in the previous 6 months; or 1.2. Receipt of dialysis (including hemodialysis, peritoneal dialysis, hemofiltration, or hemodiafiltration) within the last 7 days;

  • 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.

Exclusion criteria

  • 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;
  • 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

Inclusion criteria

1\. Included in the TXA factorial.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Factorial
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Canada · 3 centers
  • London Health Sciences Centre — London
  • Centre Hospitalier de L'Universite de Montreal (CHUM) — Montreal
  • McGill University University Health Centre — Montreal

Identifiers

NCT: NCT06337838 · 2024.BRACKETS-Pilot

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗