Furosemide Treatment Before Blood Transfusion in Patients With Systolic Dysfunction

NCT ID: NCT01705470

Last Updated: 2016-06-28

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2013-06-30

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

Detailed Description

More than 4 million patients receive a blood transfusion each year in the United States, many of them suffer from congestive heart failure. The reported prevalence of anemia in CHF is unknown, ranges widely from 4% to 70%, due to a lack of an established, consistent definition of anemia in CHF.

Treating CHF patients with furosemide prior to blood transfusion became a common practice, even though no randomize clinical trial had examine this issue. Nand et al. measured the pulmonary capillary wedge pressures in 20 adults with chronic severe anemia (Hg <6 mg/dl) and no systemic disease before and after transfusion of 700ml of whole blood. Ten of these patients were treated with furosemide (40 mg intra-venous) immediately prior the transfusion. The PCWP had increased significantly among patient who did not receive the furosemide and decreased by 3.75% among patients in the furosemide group, although this change was not was statistically significant. In another study, the same group of Nand et al. measured the PCWP among 40 chronic anemia patients receiving blood transfusion. None of the patients suffered from cardiopulmonary disease. The patients were randomly divided into 4 groups: the difference between the first 3 groups was the speed of the transfusion (2 ml/min, 5 ml/min and 10 ml/min). The fourth group patients were treated with 40 mg of furosemide before the transfusion was given in a rate of 5 ml/min. The PCWP increased significantly in the first 3 groups, with the rise being proportionately greater with faster transfusions (15.8, 20.9 and 32.2% in groups A, B and C, respectively). In the furosemide group, however, the PCWP decreased significantly by 21.7%.

Conditions

Anemia Treatment Among Patients Suffering From Left Ventricular Systolic Dysfunction

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

arm1

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

Group Type: EXPERIMENTAL

furosemide

Intervention Type: DRUG

arm2

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

Group Type: EXPERIMENTAL

placebo normal saline

Intervention Type: DRUG

Interventions

furosemide

Intervention Type: DRUG

placebo normal saline

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Edo Birati, MD

Role: PRINCIPAL_INVESTIGATOR

Tel Aviv MC

Other Identifiers

SHERLOCK

Identifier Type: -

Identifier Source: org_study_id