Transfusion-Associated Circulatory Overload Best Eliminated With Lasix

NCT02802696 | Completed Early Phase 1

• 1 other identifier: 16-5032
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

Transfusion; Transfusion Medicine; Diuretic

Outcome Measures

Primary Outcomes (1)

• Number of patients enrolled

  2 months period

Secondary Outcomes (22)

• Proportion of patients screened meeting eligibility criteria

  2 months

• Proportion of eligible patients consenting to participate

  2 months

• Proportion of patient receiving the allocated treatment

  2 months

• Proportion of treated patients completing follow-up assessment

  2 months

• Proportion of patient in which blinding was maintained throughout study

  2 months

Study Arms (2)

Furosemide

EXPERIMENTAL

Diuretic

Drug: Furosemide

Placebo

PLACEBO COMPARATOR

Normal saline

Drug: Normal Saline

Interventions

Furosemide DRUG

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.

Also known as: Lasix

Furosemide

Normal Saline DRUG

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.

Also known as: 0.9% Sodium Chloride

Placebo

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age ≥ 65 years.
• Receiving a single unit red blood cell transfusion

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• University Health Network, Toronto: collaborator
• Canadian Blood Services: collaborator

Study Sites (3)

Canadian Blood Services

Toronto, Ontario, K1G 4J5, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

Related Publications (4)

• AABB (2015) AABB Association Bulletin #15-02: Transfusion Associated Circulatory Overload (12/28/15). Vol. 2016,

  BACKGROUND

• Alam A, Lin Y, Lima A, Hansen M, Callum JL. The prevention of transfusion-associated circulatory overload. Transfus Med Rev. 2013 Apr;27(2):105-12. doi: 10.1016/j.tmrv.2013.02.001. Epub 2013 Mar 1.

  PMID: 23465703 BACKGROUND

• Lieberman L, Maskens C, Cserti-Gazdewich C, Hansen M, Lin Y, Pendergrast J, Yi QL, Callum J. A retrospective review of patient factors, transfusion practices, and outcomes in patients with transfusion-associated circulatory overload. Transfus Med Rev. 2013 Oct;27(4):206-12. doi: 10.1016/j.tmrv.2013.07.002. Epub 2013 Sep 26.

  PMID: 24075097 BACKGROUND

• Sarai M, Tejani AM. Loop diuretics for patients receiving blood transfusions. Cochrane Database Syst Rev. 2015 Feb 16;2015(2):CD010138. doi: 10.1002/14651858.CD010138.pub2.

  PMID: 25685898 BACKGROUND

MeSH Terms

Conditions

Transfusion Reaction

Interventions

Furosemide; Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Sulfanilamides; Sulfonamides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sulfones; Sulfur Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Jeannie Callum, MD

  Sunny Brook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 29, 2016
• First Posted: June 16, 2016
• Study Start: June 1, 2016
• Primary Completion: March 17, 2017
• Study Completion: April 15, 2017
• Last Updated: June 26, 2017

Record last verified: 2016-10

Locations

CA (3)