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Transfusion-Associated Circulatory Overload Best Eliminated With Lasix

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ClinicalTrials.gov Identifier: NCT02802696
Recruitment Status : Completed
First Posted : June 16, 2016
Last Update Posted : June 26, 2017
Sponsor:
Collaborators:
University Health Network, Toronto
Canadian Blood Services
Information provided by (Responsible Party):
Sunnybrook Health Sciences Centre

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.

Condition or disease Intervention/treatment Phase
Transfusion-associated Circulatory Overload Drug: Furosemide Drug: Normal Saline Early Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Pre-transfusion Furosemide in Patients at High Risk of Transfusion-associated Circulatory Overload - The Transfusion-Associated Circulatory Overload Best Eliminated With Lasix (TACO-BEL) Study: A Pilot Randomized Controlled Trial
Study Start Date : June 2016
Actual Primary Completion Date : March 17, 2017
Actual Study Completion Date : April 15, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Furosemide

Arm Intervention/treatment
Experimental: Furosemide
Diuretic
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.
Other Name: Lasix

Placebo Comparator: Placebo
Normal saline
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.
Other Name: 0.9% Sodium Chloride




Primary Outcome Measures :
  1. Number of patients enrolled [ Time Frame: 2 months period ]

Secondary Outcome Measures :
  1. Proportion of patients screened meeting eligibility criteria [ Time Frame: 2 months ]
  2. Proportion of eligible patients consenting to participate [ Time Frame: 2 months ]
  3. Proportion of patient receiving the allocated treatment [ Time Frame: 2 months ]
  4. Proportion of treated patients completing follow-up assessment [ Time Frame: 2 months ]
  5. Proportion of patient in which blinding was maintained throughout study [ Time Frame: 2 months ]
  6. Vital Signs [ Time Frame: Baseline and 6 hours post transfusion ]
    Change in vital signs immediately post-transfusion and at 6 hours post-transfusion

  7. Positive end-expiratory pressure [ Time Frame: Baseline and 6 hours post transfusion ]
    For patients on mechanical ventilation pre-transfusion, change in positive end-expiratory pressure

  8. Inspiratory oxygen [ Time Frame: Baseline and 6 hours post transfusion ]
    change in fraction of inspiratory oxygen at 6 hours post-transfusion

  9. Incidence of TACO within 6 hours from completion of transfusion [ Time Frame: within 6 hours ]
  10. Severity of TACO-graded as per the Public Health Agency of Canada's Transfusion Transmitted Injuries Surveillance System [ Time Frame: within 6 hours ]
  11. Validation of TACO as per criteria adopted from the US Center for Disease Control [ Time Frame: within 6 hours ]
  12. Change in plasma brain natriuretic peptide(BNP) [ Time Frame: Baseline and Day 1 ]
  13. Net fluid balance at 24 hours from start of transfusion- all intravenously-administered fluids (including the transfused blood product and the study intervention) [ Time Frame: Within 24 hours ]
  14. Proportion of patients developing hyponatremia or hypokalemia by Day 1 [ Time Frame: By Day 1 ]
  15. Proportion of patients developing hypotension [ Time Frame: Within 24 hours ]
  16. Proportion of patients developing acute kidney injury [ Time Frame: Within 24 hours ]
  17. Need for increased supplemental oxygen is defined as any increase in oxygen flow ≥ 1 L/hr or (fraction of inspired oxygen)FiO2 ≥ 5% of 1 hour duration or longer, prompted by either patient symptoms or a fall in oxygen saturation(SpO2) ≥ 5% [ Time Frame: Within 24 hours ]
  18. Need for inotropic support is defined as the initiation of a continuous infusion of dopamine, dobutamine, epinephrine, or norepinephrine [ Time Frame: Within 24 hours ]
  19. Need for additional diuretic or vasodilatory therapy is defined by the prescription of non-study furosemide, hydrochlorothiazide, metolazone, or either transdermal or intravenous nitroglycerin [ Time Frame: Within 24 hours ]
  20. Occurrence of acute coronary syndrome or new arrhythmia [ Time Frame: within 7 days ]
  21. Mortality during hospital stay [ Time Frame: Upto 30 days ]
  22. Length of hospital stay [ Time Frame: From date of admission until the date discharge from an acute care hospital or date of death from any cause, whichever came first, assessed up to 30 days. ]


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02802696


Locations
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Canada, Ontario
Canadian Blood Services
Toronto, Ontario, Canada, K1G 4J5
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
University Health Network
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
University Health Network, Toronto
Canadian Blood Services
Investigators
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Principal Investigator: Jeannie Callum, MD Sunny Brook Health Sciences Centre

Publications:
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Responsible Party: Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT02802696     History of Changes
Other Study ID Numbers: 16-5032
First Posted: June 16, 2016    Key Record Dates
Last Update Posted: June 26, 2017
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Sunnybrook Health Sciences Centre:
Transfusion
Transfusion Medicine
Diuretic
Additional relevant MeSH terms:
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Transfusion Reaction
Hematologic Diseases
Immune System Diseases
Furosemide
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action