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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03309839
Recruitment Status : Unknown
Verified October 2017 by Nantes University Hospital.
Recruitment status was:  Not yet recruiting
First Posted : October 16, 2017
Last Update Posted : October 16, 2017
Sponsor:
Collaborator:
Fédération Française de Cardiologie
Information provided by (Responsible Party):
Nantes University Hospital

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


Condition or disease Intervention/treatment
Cardiac Surgery Other: Blood collection

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: HLA-DR Expression in Neonates After Cardiac Surgery Under Cardiopulmonary Bypass
Estimated Study Start Date : December 1, 2017
Estimated Primary Completion Date : December 30, 2018
Estimated Study Completion Date : December 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Group/Cohort Intervention/treatment
neonates with cardiac surgery under cardiopulmonary bypass Other: Blood collection
A sample of an additional blood tube will be taken in parallel with the blood test carried out for the treatment.




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients aged ≤ 28 days after cardiac surgery under cardiopulmonary bypass
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Lack of parental consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03309839


Contacts
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Contact: Alexis Chenouard, Dr +33 (0)2 44 76 82 21 alexis.chenouard@chu-nantes.fr

Locations
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France
Nantes University Hospital
Nantes, France, 44093
Contact: Alexis Chenouard, Dr    +33 (0)2 44 76 82 21    alexis.chenouard@chu-nantes.fr   
Sponsors and Collaborators
Nantes University Hospital
Fédération Française de Cardiologie
Investigators
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Principal Investigator: Alexis Chenouard, Dr Nantes University Hospital
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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT03309839    
Other Study ID Numbers: RC17_0359
First Posted: October 16, 2017    Key Record Dates
Last Update Posted: October 16, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nantes University Hospital:
HLA-DR expression
cardiopulmonary bypass
neonate