NCT03560687

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

CardioSideral Heart Surgery: Randomized Study on Sucrosomial Iron Supplementation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,023 (actual)
• Sponsor: Cardiochirurgia E.H. · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Conditions

• Anemia

Interventions

Type	Name	Description
DRUG	Sucrosomial Iron	CardioSideral 2 caps per day

Timeline

• Start date: 2018-10-15
• Primary completion: 2020-05-01
• Completion: 2020-07-09
• First posted: 2018-06-18
• Last updated: 2020-07-13

Locations

1 site across 1 country: Italy