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| Name | Class |
|---|---|
| Carmel Medical Center | OTHER |
| The Baruch Padeh Medical Center, Poriya | OTHER_GOV |
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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.
Research Objectives
The study objectives are:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ferinject | Active Comparator | -Patients will receive 1000 mg of a ferric carboxymaltose (Ferinject type) intravenously approximately 24 hours prior to surgery |
|
| placebo | Placebo Comparator | Patients will receive a placebo drug intravenous approximately 24 hours before surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ferinject | Drug | 1000 mg of a ferric carboxymaltose (Ferinject type) intravenously approximately 24 hours prior to surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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% | • 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. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37838604 | Derived | Friedman T, Dann EJ, Bitton-Worms K, Makhoul M, Glam R, Weis A, Tam DY, Bolotin G. Intravenous iron administration before cardiac surgery reduces red blood cell transfusion in patients without anaemia. Br J Anaesth. 2023 Dec;131(6):981-988. doi: 10.1016/j.bja.2023.09.007. Epub 2023 Oct 12. |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C522335 | ferric carboxymaltose |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Placebo | Drug | Saline (normal saline, sodium chloride) |
|
|
| D017670 |
| Sodium Compounds |