RECRUITING

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

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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

Official Title

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

Quick Facts

Study Start:2025-06-30
Study Completion:2026-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06970925

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * ICU hospitalized patients who underwent non-emergent cardiac surgery
  2. * Post operative iron deficient or anemic patients (Hb\< 12 for both men and women).
  3. * Patients following the same pre-operative protocol
  4. * Age \>18 years
  1. * Post operative day 1 Hg \<9
  2. * Age \>90 years
  3. * Patients with cancer or other chronic conditions that impair erythropoiesis (e.g. MDS)
  4. * Stage 3, 4 renal disease
  5. * Intraoperative transfusion of PRBC

Contacts and Locations

Study Locations (Sites)

Englewood Hospital
Englewood, New Jersey, 07631
United States

Collaborators and Investigators

Sponsor: Englewood Hospital and Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-30
Study Completion Date2026-06-30

Study Record Updates

Study Start Date2025-06-30
Study Completion Date2026-06-30

Terms related to this study

Additional Relevant MeSH Terms

  • Cardiac Surgery