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OpenTrials
Completed

NCT Number: NCT03309839

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

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

Completed

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Key information

Conditions

Cardiac Surgery

Age range

Up to 28 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Nantes University Hospital

Nantes, 44093, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Lack of parental consent

Treatment and study plan

Blood collection

Other

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

Primary outcomes

  1. HLA-DR expression

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

    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)

Secondary outcomes

  1. Cytokines measurements

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

    Pro and anti-inflammatory cytokine concentrations in the plasma measured by multiplex immunoassay

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Collaborators

  • Fédération Française de Cardiologie

Registry information

Acronym: IMMUNOPED

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 16, 2017
Registry last updated
Sep 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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