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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
Sponsor:
Collaborators:
Carmel Medical Center
The Baruch Padeh Medical Center, Poriya
Information provided by (Responsible Party):
Gil Bolotin MD, Rambam Health Care Campus

Brief 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.


Condition or disease Intervention/treatment Phase
Anemia Drug: Ferinject Drug: Placebo Phase 4

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: ferinject
-Patients will receive 1000 mg of a ferric carboxymaltose (Ferinject type) intravenously approximately 24 hours prior to surgery
Drug: Ferinject
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
Drug: Placebo
Saline (normal saline, sodium chloride)
Other Name: Saline




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18 and older
  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:

  1. Patients who require emergency heart surgery.
  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.

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Responsible Party: Gil Bolotin MD, prof, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT02939794     History of Changes
Other Study ID Numbers: 105-02
First Posted: October 20, 2016    Key Record Dates
Last Update Posted: October 28, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Gil Bolotin MD, Rambam Health Care Campus:
cardiac surgery
hemoglobin
iron

Additional relevant MeSH terms:
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Ferric Compounds
Hematinics