Pilot Study Evaluating the Advantages of Sucrosomial® Iron Post-operative Supplementation vs Standard of Care After Cardiac Surgery

Launched by ENGLEWOOD HOSPITAL AND MEDICAL CENTER · May 13, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new type of iron supplement called Sucrosomial® Iron to see if it helps improve hemoglobin levels in patients who have just had heart surgery. Hemoglobin is a protein in our blood that carries oxygen, and after surgery, many patients can become low in iron or anemic, which can make them feel weak and tired. The trial will compare the effects of Sucrosomial® Iron to the standard iron treatment (Iron Sucrose given through an IV) over a 30-day period to see if the new supplement works just as well.

To participate in this trial, you need to be an adult over 18 who has had a planned heart surgery and is currently in the ICU with low hemoglobin levels (below 12). However, if you are very elderly (over 90), have certain health conditions like cancer or severe kidney disease, or received a blood transfusion during surgery, you would not be eligible. If you join the study, you will receive either the new iron supplement or the standard treatment, and researchers will closely monitor your recovery, including how long you stay in the hospital and whether you need any blood transfusions.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • ICU hospitalized patients who underwent non-emergent cardiac surgery
• • Post operative iron deficient or anemic patients (Hb\< 12 for both men and women).
• • Patients following the same pre-operative protocol
• • Age \>18 years
• Exclusion Criteria:
• • Post operative day 1 Hg \<9
• • Age \>90 years
• • Patients with cancer or other chronic conditions that impair erythropoiesis (e.g. MDS)
• • Stage 3, 4 renal disease
• • Intraoperative transfusion of PRBC