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NCT Number: NCT06113224

Characterization of Anti-HLA Alloimmunization After Pulmonary Valve Homograft Insertion

This is a prospective, monocentric, observational cohort study whose main objective is to describe the number and rate of patients who developed DSAs (Donor Specific Antibody) at 6 months post-surgery with implantation of a cryopreserved lung homograft.

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Key information

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Lung homograft is used in a large number of complex malformations. It is accepted that homografts may induce immune reactions in the recipient, but no immunological studies have been carried out to characterize the recipient's immune reactions to the homograft and their potential impact on valve function. In this project, the authors propose to study the immunizing character of cryopreserved lung homografts by identifying the appearance of antibodies directed against the HLA, DSA (Donor Specific Antibodies) molecules of the graft (lung homograft) at 1 month and 6 months after its surgical implantation.The primary objective will be analyzed by describing the rate of patients who developed DSA at 6 months post-surgery with implantation of a cryopreserved lung homograft.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

for control patients:

  • Patient receiving a cryopreserved pulmonary valve homograft
  • Patient aged 14 or over
  • Signature of consent by adult patients/parents/guardians and assent by children

Inclusion criteria

for patients with lung homograft :

  • Patientsreceiving a cardiac surgery with extracorporeal circulation and without lung homograft

Exclusion criteria

for both group

  • Emergency surgery patient
  • Pregnant women or childbirth within the last 6 months
  • Transfusion during the surgery or within the last 6 months
  • Patient with DSAs detected before the surgery
  • Patient with anti-HLA antibodies (non-DSAs) detected before the surgery

Treatment and study plan

Blood collection T0

Procedure

2 blood samples will be taken in addition to the pre-operative check-up.

Blood collection 6 months

Procedure

1 blood sample will be taken 6 months after surgery.

Primary outcomes

  1. Detection of DSA at 6 months

    Time frame: 6 months

    Luminex® detection of DSA at 6 months after lung homograft implantation

Secondary outcomes

  1. DSA Quantification

    Time frame: 6 months

    DSA will be quantified in patients who developed DSA 6 months after lung homograft implantation

  2. antibody anti-HDLA (non DSA) detection

    Time frame: 6 months

    Detection or non-detection of non-DSA anti-HLA antibodies will be assessed by Mean Fluorescence Intensity.

  3. Early degeneration of the homograft

    Time frame: 6 months

    The early degeneration of the homograft will be defined by the occurrence of at least one of the following criteria:

    • Need to replace lung homograft
    • Need for dilatation during catheterization of lung homografts
    • Maximum gradient across the lung homograft ≥ 30mmhg on echography at 6 months
    • Pulmonary insufficiency ≥ moderate on echography at 6 months

Study contacts

Contact information is provided by the study sponsor or research team.

Clement PIERRE, PhD

CONTACT

[email protected]

+33 491435796

Marien Lenois, PhD

CONTACT

[email protected]

+33 491386000

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Official study title

Characterization of Anti-HLA Alloimmunization After Pulmonary Valve Homograft Insertion (CAssIOPé)

Acronym: CAssIOPé

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Nov 2, 2023
Registry last updated
Nov 2, 2023

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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