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

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

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.

Study Overview

• Status: Unknown
• Conditions: Anemia
• Intervention / Treatment: Drug: Ferinject; Drug: Placebo

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).

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Rambam Health Care Campus
• Collaborators: Carmel Medical Center; The Baruch Padeh Medical Center, Poriya

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (ANTICIPATED): August 1, 2018
• Study Completion (ANTICIPATED): August 1, 2019

Study Registration Dates

• First Submitted: May 31, 2016
• First Submitted That Met QC Criteria: October 18, 2016
• First Posted (ESTIMATE): October 20, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): October 28, 2016
• Last Update Submitted That Met QC Criteria: October 27, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: cardiac surgery; hemoglobin; iron
• Other Study ID Numbers: 105-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES