Immuno-humoral Rejection Markers in Pulmonary Transplant (RHUM-TP)

Hopital Foch

Status: Completed

Conditions: Lung Transplant

Treatments: Biological: Blood test for detecting the circulatory anti-HLA antibodies by ELISA and LUMINEX tests

Study type: Interventional

Funder types: Other

Identifiers

NCT01791166

2010/49

Details and patient eligibility

About

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.

Enrollment: 53 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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53 participants in 1 patient group

Pulmonary transplant

Experimental group

Treatment:

Biological: Blood test for detecting the circulatory anti-HLA antibodies by ELISA and LUMINEX tests