The Effect of Ferric Carboxymaltose on Hemoglobin and Blood Transfusion in Cardiac Surgery
NCT ID: NCT02939794
Last Updated: 2016-10-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
200 participants
INTERVENTIONAL
2016-11-30
2019-08-31
Brief Summary
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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
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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ferinject
-Patients will receive 1000 mg of a ferric carboxymaltose (Ferinject type) intravenously approximately 24 hours prior to surgery
Ferinject
1000 mg of a ferric carboxymaltose (Ferinject type) intravenously approximately 24 hours prior to surgery
placebo
Patients will receive a placebo drug intravenous approximately 24 hours before surgery
Placebo
Saline (normal saline, sodium chloride)
Interventions
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Ferinject
1000 mg of a ferric carboxymaltose (Ferinject type) intravenously approximately 24 hours prior to surgery
Placebo
Saline (normal saline, sodium chloride)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patient candidates for open heart surgery (coronary artery bypass, valve replacement, or a combination of both).
3. Hemoglobin above 12g/dL in women and above than 13g\\dL in men.
Exclusion Criteria
2. Patients who are not hemodynamically stable or intubated pre-operatively.
3. Patients with a known sensitivity to iron.
4. Patients with a known history of allergies (rashes, etc.).
5. Patients with liver failure (alanine aminotransferase\> 3 times normal).
6. Patients with cirrhosis.
7. Patients with an active infection.
8. Patients with rheumatoid arthritis and indications of an active infection.
9. Pregnant women.
10. Lactating women.
11. Patients with anemia prior to surgery for any reason (B12 deficiency or folic acid deficiency).
12. Patients participating in another drug trial.
13. Patients treated with iron who took medication within the four weeks prior to surgery.
14. Patients who received a blood transfusion in the four weeks prior to surgery.
18 Years
99 Years
ALL
No
Sponsors
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Carmel Medical Center
OTHER
The Baruch Padeh Medical Center, Poriya
OTHER_GOV
Rambam Health Care Campus
OTHER
Responsible Party
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Gil Bolotin MD
prof
References
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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.
Other Identifiers
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105-02
Identifier Type: -
Identifier Source: org_study_id