Furosemide Treatment Before Blood Transfusion in Patients With Systolic Dysfunction

Anemia Treatment Among Patients Suffering From Left Ventricular Systolic Dysfunction Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01705470
• Other study ID #: SHERLOCK
• Status: Withdrawn
• Phase: N/A
• First received: October 9, 2012
• Last updated: June 27, 2016
• Start date: October 2012
• Est. completion date: June 2013

Study information

• Verified date: June 2016
• Source: Tel-Aviv Sourasky Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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

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%.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia Treatment Among Patients Suffering From Left Ventricular Systolic Dysfunction
• Ventricular Dysfunction, Left

Intervention

Drug:
• furosemide

• placebo normal saline

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	clinical outcome following blood transfusion, with or without Furosemide treatment	clinical outcome variables following blood transfusion, with or without Furosemide treatment, including the respiratory rate and oxygen saturation	Within 4 hours from receiving the blood transfusion	Yes