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Completed

NCT Number: NCT01791166

Immuno-humoral Rejection Markers in Pulmonary Transplant

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.

Completed

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Key information

Conditions

Lung Transplant

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital FOCH

Suresnes, Île-de-France Region, 92150, France

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

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

Biological

Primary outcomes

  1. Incidence of immune Markers of acute lung transplant rejection (Anti-HLA circulatory antibodies, neutrophils and C4d immune markers.

    Time frame: 12 months after pulmonary transplant

Sponsors and collaborators

Lead sponsor

Hopital Foch

Other

Registry information

Official study title

Humoral Rejection - Diagnostic Markers in Pulmonary Transplant.

Acronym: RHUM-TP

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Feb 13, 2013
Registry last updated
Sep 12, 2016

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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