Immuno-humoral Rejection Markers in Pulmonary Transplant

Not Applicable

Completed

• Conditions: Lung Transplant

• Registration Number: NCT01791166
• Lead Sponsor: Hopital Foch

Brief Summary

Open multicentric prospective study performed on pulmonary transplanted patients to detect the values of different diagnostic markers for immuno- humoral reaction and their roles in the humoral rejection for those patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2013-02-12
• Study First Submitted QC: 2013-02-12
• Study First Posted: 2013-02-13
• Primary Completion: 2013-10
• Study Completion: 2014-07
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-09
• Last Update Posted: 2016-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

• Both genders, more than 18 years of age.
• Patients with or without Cystic fibrosis
• Patients with no previous unilateral or bilateral pulmonary transplant or cardiopulmonary transplant
• Patients with no current other disease can affect, in short term, the process or prognosis of the transplant
• Patients had given his agreement to be enrolled in the study

Exclusion Criteria

• Patient less than 18 year-old
• Patient had previous organ transplant
• Pregnant and/or lactating women
• Female subject in reproductive age does not use effective contraceptive methode
• Alcoholisms or neuropsychosis, conditions that affect the good comprehension of the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Incidence of immune Markers of acute lung transplant rejection (Anti-HLA circulatory antibodies, neutrophils and C4d immune markers.	12 months after pulmonary transplant

Trial Locations

Locations (1)

Hôpital FOCH; 🇫🇷 Suresnes, Ile de France, France