Status:
RECRUITING
Pilot Study Evaluating the Advantages of Sucrosomial® Iron Post-operative Supplementation vs Standard of Care After Cardiac Surgery
Lead Sponsor:
Englewood Hospital and Medical Center
Conditions:
Cardiac Surgery
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06970925
Start Date
June 30 2025
End Date
June 30 2026
Last Update
August 7 2025
Active Locations (1)
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1
Englewood Hospital
Englewood, New Jersey, United States, 07631