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

Anemia Clinical Trial

— CHS  

Official title:

CardioSideral Heart Surgery: Randomized Study on Sucrosomial Iron Supplementation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03560687
• Other study ID #: 2018-1
• Status: Completed
• Phase: N/A
• Start date: October 15, 2018
• Est. completion date: July 9, 2020

Study information

• Verified date: July 2020
• Source: Cardiochirurgia E.H.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1023
• Est. completion date: July 9, 2020
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Undergoing elective Heart Surgery -

Exclusion Criteria:

• Emergent or Urgent Indication

Related Conditions & MeSH terms

• Anemia

Intervention

Drug:
• Sucrosomial Iron
CardioSideral 2 caps per day

Locations

Country	Name	City	State
Italy	Cardiochirurgia European Hospital	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Cardiochirurgia E.H.

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preoperative Hemoglobin Level	Preoperative Hemoglobin Level	30 days from enrollment
Secondary	Compliance to drug	Discontinuation rate due to adverse effects	30 days from enerollemnt
Secondary	Cost-effectiveness in terms of cost of drug vs saved blood units	Cost-effectiveness in terms of cost of drug vs saved blood units	30 days after operation
Secondary	Hemoglobin Level 24 hours after operation	Hemoglobin Level 24 hours after operation	24 hours after index operation
Secondary	Hemoglobin Level 48 hours after operation	Hemoglobin Level 48 hours after operation	48 hours after index operation