Transfusion-Associated Circulatory Overload Best Eliminated With Lasix

• Status: Completed
• Trial end date: 2017-04-15
• Target enrollment: 0
• Participant gender: All

Summary

This is a pilot double-blinded placebo-controlled randomized controlled trial (RCT) to evaluate the feasibility of conducting a multicenter, randomized, placebo-controlled trial to assess the efficacy of pre-transfusion furosemide in preventing transfusion-associated circulatory overload (TACO) in hemodynamically stable inpatients aged 65 years or older receiving a single unit red blood cell transfusion. Patients will be randomly allocated to receive either furosemide (20mg intravenous) or placebo (saline) within 60 minutes of starting a red blood cell (RBC) transfusion. Randomization will be stratified by centre and renal dysfunction (creatinine clearance ≥ 60 mL/min or < 60 mL/min). This is a blinded trial: patients, care-providers (physicians and nurses), data collectors, outcome adjudicators, and data analysts will not be aware of group allocation.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sunnybrook Health Sciences Centre
• Collaborators: Canadian Blood Services; University Health Network, Toronto
• Treatments: Furosemide

Criteria

Inclusion Criteria:

• Age ≥ 65 years.

• Receiving a single unit red blood cell transfusion

Exclusion Criteria:

• Active bleeding (active visible bleeding, required 2 or more RBC units in the preceding 24 hours, drop in Hb > 20 g/L in the preceding 24 hours);

• Hemodynamically unstable (systolic blood pressure < 90 mmHg or on inotropes);

• Anticipated major surgical procedure within 24 hours of enrolment;

• Presence of hyponatremia (Na < 130 mmol/L);

• Presence of hypokalemia (K < 3.5 mmol/L);

• Dialysis or creatinine clearance < 30 mL/min;

• Order for platelet or plasma transfusion at same time;

• Allergy to furosemide;

• Risk of withholding furosemide felt by attending physician to place patient at excessive risk of harm;

• Previously enrolled in the study;

• Plan for discharge on the day of randomization;

• Unable to provide informed consent.