Pilot Study Evaluating the Advantages of Sucrosomial® Iron Post-operative Supplementation vs Standard of Care After Cardiac Surgery
Recruiting
Early Phase 1
Interventional Study
Cardiac Surgery
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Early Phase 1
- Study type
- Interventional
- Purpose
- Supportive Care
- Participants needed
- 40 (estimated)
- Sponsor
- Englewood Hospital and Medical Center · Other
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About This Trial
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 requ…
Trial Locations
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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
*…
Contacts
No contact information available.