NCT03560687

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,023

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 7, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 18, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

October 15, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 9, 2020

Completed
Last Updated

July 13, 2020

Status Verified

July 1, 2020

Enrollment Period

1.5 years

First QC Date

June 7, 2018

Last Update Submit

July 9, 2020

Conditions

Anemia

Keywords

AnemiaHeart SurgeryIron Supplementation

Outcome Measures

Primary Outcomes (1)

  • Preoperative Hemoglobin Level

    Preoperative Hemoglobin Level

    30 days from enrollment

Secondary Outcomes (4)

  • Compliance to drug

    30 days from enerollemnt

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

    30 days after operation

  • Hemoglobin Level 24 hours after operation

    24 hours after index operation

  • Hemoglobin Level 48 hours after operation

    48 hours after index operation

Study Arms (2)

CardioSIDERAL

EXPERIMENTAL

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

Drug: Sucrosomial Iron

Control

NO INTERVENTION

Interventions

Sucrosomial IronDRUG

CardioSideral 2 caps per day

Also known as: CardioSideral
CardioSIDERAL

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Undergoing elective Heart Surgery -

You may not qualify if:

  • \- Emergent or Urgent Indication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiochirurgia European Hospital

Rome, 00152, Italy

Location

Related Publications (2)

  • Weltert LP, De Rosa A, Rondinelli MB, Falco M, Turani F, Pierelli L. Benefits of pre-operative oral Sucrosomial(R) iron supplementation in cardiac surgery: influence of patient's baseline hemoglobin and gender. Blood Transfus. 2023 Jul;21(4):305-313. doi: 10.2450/2022.0222-22. Epub 2022 Nov 25.

    PMID: 36580029DERIVED

  • Pierelli L, De Rosa A, Falco M, Papi E, Rondinelli MB, Turani F, Weltert L. Preoperative Sucrosomial Iron Supplementation Increases Haemoglobin and Reduces Transfusion Requirements in Elective Heart Surgery Patients: A Prospective Randomized Study. Surg Technol Int. 2021 Oct 28;39:321-328. doi: 10.52198/21.STI.39.CV1512.

    PMID: 34710946DERIVED

MeSH Terms

Conditions

Anemia

Interventions

sucrosomial iron

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Luca Weltert

    European Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Single blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomization of 1000 consecutive patients undergoing heart surgery to either Iron supplementation or Control
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor, Principal Investigator

Study Record Dates

First Submitted

June 7, 2018

First Posted

June 18, 2018

Study Start

October 15, 2018

Primary Completion

May 1, 2020

Study Completion

July 9, 2020

Last Updated

July 13, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)