NCT06113224

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
13mo left

Started Dec 2023

Longer than P75 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress70%
Dec 2023Jun 2027

First Submitted

Initial submission to the registry

October 27, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 2, 2023

Completed
29 days until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

November 2, 2023

Status Verified

October 1, 2023

Enrollment Period

2.5 years

First QC Date

October 27, 2023

Last Update Submit

October 27, 2023

Conditions

Lung Graft Dysfunction

Outcome Measures

Primary Outcomes (1)

  • Detection of DSA at 6 months

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

    6 months

Secondary Outcomes (3)

  • DSA Quantification

    6 months

  • antibody anti-HDLA (non DSA) detection

    6 months

  • Early degeneration of the homograft

    6 months

Study Arms (2)

Control patients

ACTIVE COMPARATOR

Patients with an indication for cardiac surgery with extracorporeal circulation but without homograft

Procedure: Blood collection T0Procedure: Blood collection 6 months

Lung homograft patients

EXPERIMENTAL

patients requiring lung homograft implantation

Procedure: Blood collection T0Procedure: Blood collection 6 months

Interventions

Blood collection T0PROCEDURE

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

Control patientsLung homograft patients
Blood collection 6 monthsPROCEDURE

1 blood sample will be taken 6 months after surgery.

Control patientsLung homograft patients

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patient receiving a cryopreserved pulmonary valve homograft
  • Patient aged 14 or over
  • Signature of consent by adult patients/parents/guardians and assent by children
  • Patientsreceiving a cardiac surgery with extracorporeal circulation and without lung homograft

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Marien Lenois, PhD

CONTACT

+33 491386000marien.lenoir@ap-hm.fr

Clement PIERRE, PhD

CONTACT

+33 491435796clement.pierre@ap-hm.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2023

First Posted

November 2, 2023

Study Start

December 1, 2023

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2027

Last Updated

November 2, 2023

Record last verified: 2023-10