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HLA-DR Expression in Neonates After Cardiac Surgery Under Cardiopulmonary Bypass

HLA-DR Expression in Neonates After Cardiac Surgery Under Cardiopulmonary Bypass

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03309839
Acronym
IMMUNOPED
Enrollment
50
Registered
2017-10-16
Start date
2018-01-29
Completion date
2019-04-13
Last updated
2021-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Surgery

Keywords

HLA-DR expression, cardiopulmonary bypass, neonate

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

Interventions

OTHERBlood collection

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

Sponsors

Fédération Française de Cardiologie
CollaboratorOTHER
Nantes University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 28 Days
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Lack of parental consent

Design outcomes

Primary

MeasureTime frameDescription
HLA-DR expressionPreoperatively, and 1, 2, 3 and 4 days after the end of cardiopulmonary bypassNumber 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)

Secondary

MeasureTime frameDescription
Cytokines measurementsPreoperatively, and 1, 2, 3 and 4 days after the end of cardiopulmonary bypassPro and anti-inflammatory cytokine concentrations in the plasma measured by multiplex immunoassay

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026