The Effect of Ferric Carboxymaltose on Hemoglobin and Blood Transfusion in Cardiac Surgery
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|ClinicalTrials.gov Identifier: NCT02939794|
Recruitment Status : Unknown
Verified October 2016 by Gil Bolotin MD, Rambam Health Care Campus.
Recruitment status was: Not yet recruiting
First Posted : October 20, 2016
Last Update Posted : October 28, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Anemia||Drug: Ferinject Drug: Placebo||Phase 4|
The study objectives are:
- Determine hemoglobin values in non-anemic patients given ferric Carboxymaltose prior to and post heart surgery.
- 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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||The Effect of Intra Venus Ferric Carboxymaltose Preoperative on Hemoglobin and Blood Transfusion Post Cardiac Surgery|
|Study Start Date :||November 2016|
|Estimated Primary Completion Date :||August 2018|
|Estimated Study Completion Date :||August 2019|
Active Comparator: ferinject
-Patients will receive 1000 mg of a ferric carboxymaltose (Ferinject type) intravenously approximately 24 hours prior to surgery
1000 mg of a ferric carboxymaltose (Ferinject type) intravenously approximately 24 hours prior to surgery
Other Name: ferric carboxymaltose
Placebo Comparator: placebo
Patients will receive a placebo drug intravenous approximately 24 hours before surgery
Saline (normal saline, sodium chloride)
Other Name: Saline
- In order to determine the effect of ferric Carboxymaltose in non-anemic patients prior to surgery on the number of blood units administer postoperation, we will count the number of red packed cells and hemoglobin will be measured in gr\dl% [ Time Frame: 2 years ]• All patients post heart surgery will be admitted to the intensive care unit cardiac surgery for a minimum of 48 hours. The unit has regular and routine monitoring for blood tests (blood chemistry panel, coagulation) and blood gases.