NCT03309839

Brief Summary

The purpose of this study is to determine how monocyte HLA-DR and other markers of immune function change with time in neonates who underwent cardiac surgery with cardiopulmonary bypasss. We hypothesize that HLA-DR expression in neonates is predictive of septic complications after cardiopulmonary bypass

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 10, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 16, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

January 29, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 14, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 13, 2019

Completed
Last Updated

September 24, 2021

Status Verified

September 1, 2021

Enrollment Period

1.1 years

First QC Date

October 10, 2017

Last Update Submit

September 20, 2021

Conditions

Cardiac Surgery

Keywords

HLA-DR expressioncardiopulmonary bypassneonate

Outcome Measures

Primary Outcomes (1)

  • HLA-DR expression

    Number of HLA-DR molecules per monocyte (AB/c) determined by flow cytometry on whole blood using a Quantibrite phycoerythrin fluorescence quantitation kit (BD Biosciences) Number of HLA-DR molecules per monocyte (AB/c) determined by flow cytometry on whole blood using a Quantibrite phycoerythrin fluorescence quantitation kit (BD Biosciences)

    Preoperatively, and 1, 2, 3 and 4 days after the end of cardiopulmonary bypass

Secondary Outcomes (1)

  • Cytokines measurements

    Preoperatively, and 1, 2, 3 and 4 days after the end of cardiopulmonary bypass

Study Arms (1)

neonates with cardiac surgery under cardiopulmonary bypass

Other: Blood collection

Interventions

Blood collectionOTHER

A sample of an additional blood tube will be taken in parallel with the blood test carried out for the treatment.

neonates with cardiac surgery under cardiopulmonary bypass

Eligibility Criteria

AgeUp to 28 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Patients aged ≤ 28 days after cardiac surgery under cardiopulmonary bypass

You may qualify if:

  • Patients aged ≤ 28 days
  • Admission after cardiac surgery under cardiopulmonary bypass

You may not qualify if:

  • Lack of parental consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nantes University Hospital

Nantes, 44093, France

Location

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Alexis Chenouard, Dr

    Nantes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 10, 2017

First Posted

October 16, 2017

Study Start

January 29, 2018

Primary Completion

March 14, 2019

Study Completion

April 13, 2019

Last Updated

September 24, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)