CardioSideral Heart Surgery: Randomized Study on Sucrosomial Iron Supplementation Before Heart Surgery

Not Applicable

Completed

• Conditions: Anemia
• Interventions: Drug: Sucrosomial Iron

• Registration Number: NCT03560687
• Lead Sponsor: Cardiochirurgia E.H.

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

Study Timeline

• Study First Submitted: 2018-06-07
• Study First Submitted QC: 2018-06-07
• Study First Posted: 2018-06-18
• Study Start: 2018-10-15
• Primary Completion: 2020-05-01
• Status Verified: 2020-07
• Study Completion: 2020-07-09
• Last Update Submitted: 2020-07-09
• Last Update Posted: 2020-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1023

Inclusion Criteria

Undergoing elective Heart Surgery -

Exclusion Criteria

• Emergent or Urgent Indication

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CardioSIDERAL	Sucrosomial Iron	Adminsitration of 2 pills per day of CArdiosideral from 30 days before operation to time of operation

Primary Outcome Measures

Name	Time	Method
Preoperative Hemoglobin Level	30 days from enrollment	Preoperative Hemoglobin Level

Secondary Outcome Measures

Name	Time	Method
Compliance to drug	30 days from enerollemnt	Discontinuation rate due to adverse effects
Cost-effectiveness in terms of cost of drug vs saved blood units	30 days after operation	Cost-effectiveness in terms of cost of drug vs saved blood units
Hemoglobin Level 24 hours after operation	24 hours after index operation	Hemoglobin Level 24 hours after operation
Hemoglobin Level 48 hours after operation	48 hours after index operation	Hemoglobin Level 48 hours after operation

Trial Locations

Locations (1)

Cardiochirurgia European Hospital; 🇮🇹 Rome, Italy