Monitoring of Donor-specific Antibodies After Treatment With Immunoglobulins, Plasmapheresis and Rituximab in Lung Transplantation

Hannover Medical School340 enrolled

Overview

Single-arm, prospective observational study

This is an observational study to monitor the treatment of donor-specific antibodies in lung transplant recipients with detection of donor-specific antibodies. All consented subjects will be approached for participation. The study will evaluate the effectiveness of the treatment protocol of donor-specific antibodies with Immunoglobulins or combined treatment with Immunoglobulins, Plasmapheresis and Rituximab after lung transplantation.

Study Type

OBSERVATIONAL

Enrollment

340

Conditions

Lung Transplantation Donor-specific Anti-human Leukocyte Antigen(HLA) Antibodies

Interventions

blood samplesDIAGNOSTIC_TEST

For performing the Luminex solid phase assay (SPA) test, 7.5 ml of patient whole blood are collected from a peripheral vein.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * all patients after lung transplantation with detection of donor-specific antibodies Exclusion Criteria: * none

Locations (1)

Hannover Medical School, Department of Cardiothoracic, Transplant and Vascular Surgery

Hanover, Germany

Outcomes

Primary Outcomes

Donor-specific Antibodies Clearance

The DSA clearance is defined as absence of DSA in the Luminex test, which is performed every 6 months after treatment end.

Time frame: 6, 12, 18, 24 months

Secondary Outcomes

Graft survival

Graft survival is defined as freedom from mortality and re-transplantation

Time frame: 1, 3, 5 years

Incidence of acute cellular and humoral rejections and chronic lung allograft dysfunction (CLAD)

Time frame: 1, 3, 5 years

Data from ClinicalTrials.gov

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