CardioSideral Heart Surgery: Randomized Study on Sucrosomial Iron Supplementation Before Heart Surgery (CHS)

July 9, 2020 updated by: Luca Weltert, Cardiochirurgia E.H.

CardioSideral Heart Surgery: Randomized Study on Sucrosomial Iron Supplementation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

1023

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00152
        • Cardiochirurgia European Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Undergoing elective Heart Surgery -

Exclusion Criteria:

- Emergent or Urgent Indication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Drug: Sucrosomial Iron
CardioSideral 2 caps per day
Other Names:
  • CardioSideral

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

This is where you will find people and organizations involved with this study.

Sponsor

Cardiochirurgia E.H.

Investigators

  • Principal Investigator: Luca Weltert, European Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2018

Primary Completion (Actual)

May 1, 2020

Study Completion (Actual)

July 9, 2020

Study Registration Dates

First Submitted

June 7, 2018

First Submitted That Met QC Criteria

June 7, 2018

First Posted (Actual)

June 18, 2018

Study Record Updates

Last Update Posted (Actual)

July 13, 2020

Last Update Submitted That Met QC Criteria

July 9, 2020

Last Verified

July 1, 2020

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)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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