Health TrialsbyHealthPanel

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

ConditionsChronic Kidney DiseasesAcute Kidney InjuryBleedingSurgery
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

This trial does not accept healthy volunteers

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

Design model

Factorial

Treatments tested in this trial

  • Desmopressin Injectable Solution

    Drug

    Intravenous desmopressin, 20 mcg, single dose administration.

  • Tranexamic Acid Injectable Product

    Drug

    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.

  • Placebo

    Other intervention

    Intravenous 0.9% saline solution

Treatment groups

100 Participants
are divided into 4 treatment groups
Group A: Prophylactic intravenous tranexamic acid and prophylactic intravenous desmopressin.Experimental treatment 2 interventions
Group B: Prophylactic intravenous tranexamic acid and placebo.Experimental treatment 2 interventions
Group C: Prophylactic intravenous desmopressin and placebo.Experimental treatment 2 interventions
Group D: Placebo and placebo.Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Rate of recruitment

A rate of 0.25 patients per study site per week

Time frame
Through study completion, an average of 1.5 years
2

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

Time frame
Day of surgery
3

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

Time frame
Day of surgery
4

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

Time frame
30 days after randomization

Secondary outcomes

1

Bleeding Independently Associated with Mortality after noncardiac Surgery (BIMS)

Number of patients who experience BIMS

Time frame
30 days after randomization
2

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. 1. denotes bleeding and post-operative hemoglobin \<70 g/L or 1 unit of blood (red blood cells or whole blood) transfused. 2. denotes bleeding and 2 units transfused. 3. denotes bleeding and 3 units transfused. 4. denotes bleeding and 4 units transfused 5. denotes bleeding and 5 units transfused. 6. denotes bleeding and 6 units transfused. 7. denotes bleeding and 7 units transfused. 8. denotes bleeding and 8 or more units of blood transfused. 9. denotes reoperation for reasons of bleeding. 10. denotes death imminently or directly caused by bleeding.

Time frame
30 days after randomization
3

Reoperation for reasons of bleeding

Number of patients who return to the operating room for surgical management of suspected documented bleeding

Time frame
30 days after randomization
4

Blood (red blood cells or whole blood) transfused

Number of units of blood transfused.

Time frame
30 days after randomization

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hamilton Health Sciences Corporation

Lead sponsor

Population Health Research Institute

Collaborator

Source ClinicalTrials.gov
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