NCT04980911

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,711

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2021

Shorter than P25 for all trials

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

Study Start

First participant enrolled

April 12, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 28, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 18, 2022

Completed
Last Updated

August 31, 2022

Status Verified

August 1, 2022

Enrollment Period

11 months

First QC Date

July 21, 2021

Last Update Submit

August 30, 2022

Conditions

AnemiaCardiac Surgery

Outcome Measures

Primary Outcomes (1)

  • Number of transfusion

    number of perioperative and post-operative transfusion

    Day 7

Secondary Outcomes (2)

  • Number of post operative complications

    Day 7

  • Percentage of death

    Day 7

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient with iron deficiency and with a scheduled cardiac surgery

You may qualify if:

  • Patient with cardiac surgery
  • With iron deficiency with or without anemia

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHR Metz Thionville

Metz, Moselle, 57085, France

Location

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2021

First Posted

July 28, 2021

Study Start

April 12, 2021

Primary Completion

March 18, 2022

Study Completion

March 18, 2022

Last Updated

August 31, 2022

Record last verified: 2022-08

Locations

FR(1)