Iron Deficiency and Anemia in Cardiac Surgery | NCT04980911

Studies
Iron Deficiency and Anemia in Cardiac Surgery

NCT04980911

Sponsor

Centre Hospitalier Régional Metz-Thionville

Status

Completed

Last Update Posted

Aug 31, 2022Actual

Enrollment

1,711Actual

Phase

Not provided

Conditions

Anemia
Cardiac Surgery

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 12, 2021Actual

Primary Completion Date

Mar 18, 2022Actual

Completion Date

Mar 18, 2022Actual

First Submitted Date

Jul 21, 2021

First Submission Date that Met QC Criteria

Jul 21, 2021

First Posted Date

Jul 28, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 30, 2022

Last Update Posted Date

Aug 31, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Anemia and preoperative iron deficit in cardiac surgery are associated by an increased volume of transfusion and an increase in complications and/or mortality. Recent studies have shown that EPO and iron administration the days preceding the operation results in a reduction of perioperative transfusion for patients with preoperative anemia.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,711Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of transfusion	number of perioperative and post-operative transfusion	Day 7

Secondary Outcomes

Measure	Description	Time Frame
Number of post operative complications	Number of post-operative complications	Day 7
Percentage of death	Percentage of post-operative death

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient with cardiac surgery
With iron deficiency with or without anemia

Exclusion Criteria:

Anemia without iron deficiency
Iron overload
Jehovah's witnesses
Endocarditis
Treating neoplasia
Uncontrolled hypertension
With infection
Alfa-epoetin hypersensitivity
Hypersensitivity of hamster's protein
Erythroblastopenia induced by erythropoietin
Ferinject or mannitol allergy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patient with iron deficiency and with a scheduled cardiac surgery

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHR Metz Thionville		Metz	Moselle	57085	France

Condition Browse Module

MeSH Terms

ID	Term
D000740	Anemia

Ancestor Terms

ID	Term
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided