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

• Status: Unknown status
• Trial end date: 2019-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

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

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.