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The Effect of Ferric Carboxymaltose on Hemoglobin and Blood Transfusion in Cardiac Surgery

NCT02939794 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2016-10-28

No results posted yet for this study

Summary

Anemia after cardiac surgery is a vast phenomena. More than 70% of the patients who under went surgery represented with hemoglobin less than 8 mg/dl (the cutoff for blood transfusion) and more than 80% of the patients receives at least one unit of red blood cell transfusion.

There were number of attempts to prevent the postoperative anemia by giving erythropoietin, Iron per os and intra venus iron. non of the above have shown increase in Hemoglobin after the cardiac surgery.

Conditions

Interventions

DRUG

Ferinject

1000 mg of a ferric carboxymaltose (Ferinject type) intravenously approximately 24 hours prior to surgery

DRUG

Placebo

Saline (normal saline, sodium chloride)

Sponsors & Collaborators

  • Carmel Medical Center

    collaborator OTHER

  • The Baruch Padeh Medical Center, Poriya

    collaborator OTHER_GOV

  • Rambam Health Care Campus

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2018-08-31
Completion
2019-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02939794 on ClinicalTrials.gov