NCT01705470

Brief Summary

The study Objective is to assess the clinical and echocardiographic changes of patients with systolic dysfunction receiving blood transfusion, with or without prior treatment with furosemide

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2012

Shorter than P25 for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

October 9, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 12, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

June 28, 2016

Status Verified

June 1, 2016

Enrollment Period

8 months

First QC Date

October 9, 2012

Last Update Submit

June 27, 2016

Conditions

Anemia Treatment Among Patients Suffering From Left Ventricular Systolic Dysfunction

Keywords

FurosemideAnemiaLV dysfunctionblood transfusion

Outcome Measures

Primary Outcomes (1)

  • Diastolic echocardiographic changes following blood transfusion, with or without Furosemide treatment

    Diastolic echocardiographic variables, including Ea, E to Ea ratio, E to A ratio, and Pulmonary vein flow velocities, following blood transfusion, with or without Furosemide treatment

    Within 4 hours from receiving the blood transfusion

Secondary Outcomes (1)

  • clinical outcome following blood transfusion, with or without Furosemide treatment

    Within 4 hours from receiving the blood transfusion

Study Arms (2)

arm1

EXPERIMENTAL

will receive 60 mg (6 ml) of intra-venous furosemide before administration of the blood transfusion (250-300 ml of packed cells).

Drug: furosemide

arm2

EXPERIMENTAL

will receive 6 ml of normal saline (NaCl 0.9%) before administration of the blood transfusion (250-300 ml of packed cells).

Drug: placebo normal saline

Interventions

furosemideDRUG
arm1
placebo normal salineDRUG
arm2

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject is over 18 years old.
  • Documented ejection function equal to or over 40% in prior tests
  • The treating physician decided to treat the patient with packed cell

You may not qualify if:

  • Known hypersensitivity to furosemide.
  • Calculated creatinine clearance over 20% (by MDRD)
  • Past adverse reaction to blood product.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

AnemiaVentricular Dysfunction, Left

Interventions

Furosemide

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesVentricular DysfunctionHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

SulfanilamidesSulfonamidesAmidesOrganic ChemicalsAniline CompoundsAminesSulfonesSulfur Compounds

Study Officials

  • Edo Birati, MD

    Tel Aviv MC

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2012

First Posted

October 12, 2012

Study Start

October 1, 2012

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

June 28, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share