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

Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02939794
• Other study ID #: 105-02
• Status: Not yet recruiting
• Phase: Phase 4
• First received: May 31, 2016
• Last updated: October 27, 2016
• Start date: November 2016
• Est. completion date: August 2019

Study information

• Verified date: October 2016
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: August 2019
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia

Intervention

Drug:
• Ferinject
1000 mg of a ferric carboxymaltose (Ferinject type) intravenously approximately 24 hours prior to surgery
• Placebo
Saline (normal saline, sodium chloride)

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Rambam Health Care Campus	Carmel Medical Center, The Baruch Padeh Medical Center, Poriya

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No