- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03560687
CardioSideral Heart Surgery: Randomized Study on Sucrosomial Iron Supplementation Before Heart Surgery (CHS)
CardioSideral Heart Surgery: Randomized Study on Sucrosomial Iron Supplementation
Study Overview
Detailed Description
This randomized, single blind (Outcomes Assessor), non-profit study is aimed at verifying whether routine preoperative supplementation with Sucrosomial® Iron in patients scheduled for cardiac surgery may increase baseline haemoglobin, constrain the haemoglobin decrease between postoperative day 2 and 3 (haemoglobin drift), and reduce the postoperative transfusion requirements, in order to identify a new strategy for pre-hospitalization optimization and post-operative recovery.
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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Rome, Italy, 00152
- Cardiochirurgia European Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Undergoing elective Heart Surgery -
Exclusion Criteria:
- Emergent or Urgent Indication
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
|
|
Experimental: CardioSIDERAL
Adminsitration of 2 pills per day of CArdiosideral from 30 days before operation to time of operation
|
CardioSideral 2 caps per day
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Preoperative Hemoglobin Level
Time Frame: 30 days from enrollment
|
Preoperative Hemoglobin Level
|
30 days from enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Compliance to drug
Time Frame: 30 days from enerollemnt
|
Discontinuation rate due to adverse effects
|
30 days from enerollemnt
|
Cost-effectiveness in terms of cost of drug vs saved blood units
Time Frame: 30 days after operation
|
Cost-effectiveness in terms of cost of drug vs saved blood units
|
30 days after operation
|
Hemoglobin Level 24 hours after operation
Time Frame: 24 hours after index operation
|
Hemoglobin Level 24 hours after operation
|
24 hours after index operation
|
Hemoglobin Level 48 hours after operation
Time Frame: 48 hours after index operation
|
Hemoglobin Level 48 hours after operation
|
48 hours after index operation
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Luca Weltert, European Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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