CardioSideral Heart Surgery: Randomized Study on Sucrosomial Iron Supplementation Before Heart Surgery
NCT ID: NCT03560687
Last Updated: 2020-07-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1023 participants
INTERVENTIONAL
2018-10-15
2020-07-09
Brief Summary
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Detailed Description
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Secondary Objectives are
* Changes in blood chemistry and biochemical tests between pre- and post-intervention
* Evaluation of tolerability and compliance of supplementation with Sucrosomal Iron
* Reduction in the number of transfusions and blood bags used
* Evaluation of cost-effectiveness
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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CardioSIDERAL
Adminsitration of 2 pills per day of CArdiosideral from 30 days before operation to time of operation
Sucrosomial Iron
CardioSideral 2 caps per day
Control
No interventions assigned to this group
Interventions
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Sucrosomial Iron
CardioSideral 2 caps per day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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Cardiochirurgia E.H.
OTHER
Responsible Party
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Luca Weltert
Clinical Professor, Principal Investigator
Principal Investigators
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Luca Weltert
Role: PRINCIPAL_INVESTIGATOR
European Hospital
Locations
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Cardiochirurgia European Hospital
Rome, , Italy
Countries
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References
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Weltert LP, De Rosa A, Rondinelli MB, Falco M, Turani F, Pierelli L. Benefits of pre-operative oral Sucrosomial(R) iron supplementation in cardiac surgery: influence of patient's baseline hemoglobin and gender. Blood Transfus. 2023 Jul;21(4):305-313. doi: 10.2450/2022.0222-22. Epub 2022 Nov 25.
Pierelli L, De Rosa A, Falco M, Papi E, Rondinelli MB, Turani F, Weltert L. Preoperative Sucrosomial Iron Supplementation Increases Haemoglobin and Reduces Transfusion Requirements in Elective Heart Surgery Patients: A Prospective Randomized Study. Surg Technol Int. 2021 Oct 28;39:321-328. doi: 10.52198/21.STI.39.CV1512.
Other Identifiers
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2018-1
Identifier Type: -
Identifier Source: org_study_id
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