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Transfusion-Associated Circulatory Overload Best Eliminated With Lasix

NCT02802696 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2017-06-26

No results posted yet for this study

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.

Conditions

  • Transfusion-associated Circulatory Overload

Interventions

DRUG

Furosemide

A bolus dose of 20mg furosemide (20mg/2mL) will be given intravenously by slow intravenous push within 60 minutes prior to the start of the red blood cell transfusion; infusion via minibag is also acceptable.

DRUG

Normal Saline

A single bolus dose of 2 mL normal saline will be given intravenously immediately within 60 minutes prior to the start of the red blood cell transfusion; infusion via minibag is also acceptable.

Sponsors & Collaborators

  • University Health Network, Toronto

    collaborator OTHER

  • Canadian Blood Services

    collaborator OTHER

  • Sunnybrook Health Sciences Centre

    lead OTHER

Principal Investigators

  • Jeannie Callum, MD · Sunny Brook Health Sciences Centre

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2017-03-17
Completion
2017-04-15

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02802696 on ClinicalTrials.gov