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

Launched by HAMILTON HEALTH SCIENCES CORPORATION · Mar 22, 2024

Keywords

ClinConnect Summary

The BRACKETS pilot trial is a research study that aims to see if two medications, tranexamic acid (TXA) and desmopressin, can help reduce bleeding in patients with chronic kidney diseases or acute kidney injury who are having non-heart-related surgeries. This trial is looking for participants aged 18 and older who have significant kidney problems, such as those with a very low kidney function or those who are currently on dialysis. To take part, patients must also expect to stay in the hospital for at least one night after their surgery.

If eligible, participants will be randomly assigned to receive either the medications or a placebo (a substance with no active medication) before their surgery. This means some patients will get the actual treatment, while others will receive a dummy treatment to see how well the medications work compared to not taking them. It’s important to know that this trial is not yet recruiting participants, and it has specific criteria to ensure safety, such as excluding patients who are planning certain types of surgeries or who have specific health conditions. Overall, this study could help improve the safety of surgical procedures for patients with kidney issues by potentially reducing the risk of bleeding.

Gender

ALL

Eligibility criteria

• Eligibility criteria specific to the tranexamic acid (TXA) factorial component of trial Inclusion Criteria:
• 1. 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;
• • 2. Planned noncardiac surgery (elective, urgent, or emergency surgery);
• • 3. Expected to require at least an overnight hospital admission after surgery;
• • 4. Age ≥18 years; and
• • 5. Informed consent is obtained to participate in the BRACKETS-Pilot Trial.
• Exclusion Criteria:
• • 1. Undergoing cardiac surgery;
• • 2. Undergoing intracranial neurosurgery;
• • 3. Undergoing surgery for creation or revision of arteriovenous fistula or graft for dialysis access;
• • 4. Planned use of prophylactic systemic TXA or ϵ-aminocaproic acid;
• • 5. Hypersensitivity or known allergy to TXA;
• • 6. History of seizure disorder;
• • 7. Recent (within 90 days) stroke, myocardial infarction, acute arterial thrombosis, deep venous thrombosis, pulmonary embolism, or thrombosis of an arteriovenous fistula or graft;
• • 8. History of thrombotic thrombocytopenic purpura, atypical hemolytic uremic syndrome, or antiphospholipid antibody syndrome;
• • 9. 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
• • 10. 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:
• • 1. The hospital does not have access to desmopressin;
• • 2. Planned use of prophylactic desmopressin;
• • 3. Most recent serum sodium concentration \< 130 mEq/L;
• • 4. Known or suspected von Willebrand disease (any kind), hemophilia, or platelet function disorder; or
• • 5. Hypersensitivity or known allergy to desmopressin.