RECRUITING

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

Description

Primary objective: to evaluate the non-inferiority in terms of improvement of hemoglobin (Hg) levels within 30 days postoperatively between two proposed treatments. Secondary objective: to evaluate the financial costs associated with Sucrosomial® Iron treatment compared to Iron Sucrose (IV), while demonstrating non-inferiority in the improvement of hemoglobin levels, reduction in transfusion requirements, and reduction of hospital/ICU stay length

Conditions

Cardiac Surgery
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Related Conditions:

Cardiac Surgery

Study Overview

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Study Details

Study overview

Primary objective: to evaluate the non-inferiority in terms of improvement of hemoglobin (Hg) levels within 30 days postoperatively between two proposed treatments. Secondary objective: to evaluate the financial costs associated with Sucrosomial® Iron treatment compared to Iron Sucrose (IV), while demonstrating non-inferiority in the improvement of hemoglobin levels, reduction in transfusion requirements, and reduction of hospital/ICU stay length

Pilot Study Evaluating Efficacy and Economic Advantage of Sucrosomial® Iron Post-operative Supplementation vs Standard of Care in Patients After Cardiac Surgery

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

Condition
Cardiac Surgery
Intervention / Treatment

-

Contacts and Locations

Englewood

Englewood Hospital, Englewood, New Jersey, United States, 07631

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Englewood Hospital and Medical Center,

Study Record Dates

2026-06-30