NCT02939794

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

The Effect of Intra Venus Ferric Carboxymaltose Preoperative on Hemoglobin and Blood Transfusion Post Cardiac Surgery

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Rambam Health Care Campus · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Research Objectives The study objectives are: 1. Determine hemoglobin values in non-anemic patients given ferric Carboxymaltose prior to and post heart surgery. 2. Determine the effect of ferric Carboxymaltose in non-anemic patients prior to surgery on the number of blood units administer postoperation. Research Methods Prospective, randomized, double-blind, placebo-controlled research. All patients who are in the cardiac surgery department for bypass surgery, valve replacement surgery or combined surgery will be eligible to participate in the study. The study will be presented and explained to all patients and, if they consent, patients will be divided into two random groups. One group will receive Ferinject IV 24-48 hours prior to surgery. The second group will receive a placebo drug in the same time period as when the drug Ferinject is administered. The Population Studied All patients aged 18 or older hospitalized at the Rambam Medical Center and are candidates for open-heart surgery (coronary artery bypass, valve, combined).

Conditions

• Anemia

Interventions

Type	Name	Description
DRUG	Ferinject	1000 mg of a ferric carboxymaltose (Ferinject type) intravenously approximately 24 hours prior to surgery
DRUG	Placebo	Saline (normal saline, sodium chloride)

Timeline

• Start date: 2016-11-01
• Primary completion: 2018-08-01
• Completion: 2019-08-01
• First posted: 2016-10-20
• Last updated: 2016-10-28