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Completed

NCT Number: NCT03560687

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

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.

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Key information

Conditions

Anemia Hematologic Diseases Hemic and Lymphatic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cardiochirurgia European Hospital

Rome, 00152, Italy

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Undergoing elective Heart Surgery -

Exclusion criteria

  • Emergent or Urgent Indication

Treatment and study plan

Sucrosomial Iron

Drug

CardioSideral 2 caps per day

Other names: CardioSideral

Primary outcomes

  1. Preoperative Hemoglobin Level

    Time frame: 30 days from enrollment

    Preoperative Hemoglobin Level

Secondary outcomes

  1. Compliance to drug

    Time frame: 30 days from enerollemnt

    Discontinuation rate due to adverse effects

  2. Cost-effectiveness in terms of cost of drug vs saved blood units

    Time frame: 30 days after operation

    Cost-effectiveness in terms of cost of drug vs saved blood units

  3. Hemoglobin Level 24 hours after operation

    Time frame: 24 hours after index operation

    Hemoglobin Level 24 hours after operation

  4. Hemoglobin Level 48 hours after operation

    Time frame: 48 hours after index operation

    Hemoglobin Level 48 hours after operation

Sponsors and collaborators

Lead sponsor

Cardiochirurgia E.H.

Other

Registry information

Official study title

CardioSideral Heart Surgery: Randomized Study on Sucrosomial Iron Supplementation

Acronym: CHS

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jun 18, 2018
Registry last updated
Jul 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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