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

Conditions

Anemia

Keywords

Anemia, Heart Surgery, Iron Supplementation

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

Weltert LP, De Rosa A, Rondinelli MB, Falco M, Turani F, Pierelli L.

2022-11-257 citations

10.2450/2022.0222-22

Preoperative Sucrosomial Iron Supplementation Increases Haemoglobin and Reduces Transfusion Requirements in Elective Heart Surgery Patients: A Prospective Randomized Study

Luca Pierelli, Alessandro Rosa, M Falco, Elsie Papi, Maria Beatrice Rondinelli et al. (7 authors)

Surgical Technology Online2021-06-0114 citations

10.52198/21.sti.39.cv1512

Papers published before 2007-03-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGSucrosomial Iron

CardioSideral 2 caps per day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Masking description

Single blinded

Intervention model description

Randomization of 1000 consecutive patients undergoing heart surgery to either Iron supplementation or Control

Eligibility

Sex/Gender

ALL

Healthy volunteers

No

Inclusion criteria

Undergoing elective Heart Surgery -

Exclusion criteria

\- Emergent or Urgent Indication

Design outcomes

Primary

Measure	Time frame	Description
Preoperative Hemoglobin Level	30 days from enrollment	Preoperative Hemoglobin Level

Secondary

Measure	Time frame	Description
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

Countries

Italy

Outcome results

None listed