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

C

Cardiochirurgia E.H.

Status

Completed

Conditions

Anemia

Treatments

Drug: Sucrosomial Iron

Study type

Interventional

Funder types

Other

Identifiers

NCT03560687

2018-1

Details and patient eligibility

About

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.

Full 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

1,023 participants in 2 patient groups

CardioSIDERAL

Experimental group

Description:

Adminsitration of 2 pills per day of CArdiosideral from 30 days before operation to time of operation

Treatment:

Drug: Sucrosomial Iron

Control

No Intervention group

Trial contacts and locations

1

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