Back to resultsCardioSideral Heart Surgery: Randomized Study on Sucrosomial Iron Supplementation Before Heart Surgery (CHS)
Primary Purpose
Anemia
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Sucrosomial Iron
Sponsored by
About this trial
This is an interventional treatment trial for Anemia focused on measuring Anemia, Heart Surgery, Iron Supplementation
Eligibility Criteria
Inclusion Criteria:
Undergoing elective Heart Surgery -
Exclusion Criteria:
- Emergent or Urgent Indication
Sites / Locations
- Cardiochirurgia European Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
CardioSIDERAL
Control
Arm Description
Adminsitration of 2 pills per day of CArdiosideral from 30 days before operation to time of operation
Outcomes
Primary Outcome Measures
Preoperative Hemoglobin Level
Preoperative Hemoglobin Level
Secondary Outcome Measures
Compliance to drug
Discontinuation rate due to adverse effects
Cost-effectiveness in terms of cost of drug vs saved blood units
Cost-effectiveness in terms of cost of drug vs saved blood units
Hemoglobin Level 24 hours after operation
Hemoglobin Level 24 hours after operation
Hemoglobin Level 48 hours after operation
Hemoglobin Level 48 hours after operation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03560687
Brief Title
CardioSideral Heart Surgery: Randomized Study on Sucrosomial Iron Supplementation Before Heart Surgery
Acronym
CHS
Official Title
CardioSideral Heart Surgery: Randomized Study on Sucrosomial Iron Supplementation
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
October 15, 2018 (Actual)
Primary Completion Date
May 1, 2020 (Actual)
Study Completion Date
July 9, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cardiochirurgia E.H.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia
Keywords
Anemia, Heart Surgery, Iron Supplementation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomization of 1000 consecutive patients undergoing heart surgery to either Iron supplementation or Control
Masking
Outcomes Assessor
Masking Description
Single blinded
Allocation
Randomized
Enrollment
1023 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CardioSIDERAL
Arm Type
Experimental
Arm Description
Adminsitration of 2 pills per day of CArdiosideral from 30 days before operation to time of operation
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Sucrosomial Iron
Other Intervention Name(s)
CardioSideral
Intervention Description
CardioSideral 2 caps per day
Primary Outcome Measure Information:
Title
Preoperative Hemoglobin Level
Description
Preoperative Hemoglobin Level
Time Frame
30 days from enrollment
Secondary Outcome Measure Information:
Title
Compliance to drug
Description
Discontinuation rate due to adverse effects
Time Frame
30 days from enerollemnt
Title
Cost-effectiveness in terms of cost of drug vs saved blood units
Description
Cost-effectiveness in terms of cost of drug vs saved blood units
Time Frame
30 days after operation
Title
Hemoglobin Level 24 hours after operation
Description
Hemoglobin Level 24 hours after operation
Time Frame
24 hours after index operation
Title
Hemoglobin Level 48 hours after operation
Description
Hemoglobin Level 48 hours after operation
Time Frame
48 hours after index operation
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Undergoing elective Heart Surgery -
Exclusion Criteria:
- Emergent or Urgent Indication
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luca Weltert
Organizational Affiliation
European Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiochirurgia European Hospital
City
Rome
ZIP/Postal Code
00152
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34710946
Citation
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.
Results Reference
derived
Learn more about this trial
CardioSideral Heart Surgery: Randomized Study on Sucrosomial Iron Supplementation Before Heart Surgery
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