Immunoglobulin therapy in Lung Transplant
- Conditions
- TransplantationRespiratory - Other respiratory disorders / diseases
- Registration Number
- ACTRN12618001394235
- Lead Sponsor
- The Alfred Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
•Male and female aged greater than or equal to 18 years
•Undergoing single lung transplant, bilateral sequential lung transplant (BSLT) or heart-lung transplant (HLT)
•Able to give written informed consent
•Able to understand and comply with all trial requirements
•Known allergy to IVIg
•Active treatment for acute cellular or antibody mediated rejection
•Known history of severe selective IgA deficiency (<5mg/dL)
•Patients who have received IVIg pre- or post –transplant for any medical indication
•History of non-provoked thrombotic events in preceding 3 months
•LTx recipients who are not followed up long-term at Alfred Health
•Re-transplant
•Hospitalisation requiring intubation or mechanical ventilation at the time of enrolment.
•Any other severe condition which in the investigator’s judgment may interfere with the trial evaluations or severely compromise patient safety
•Currently involved in another investigational interventional trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Composite analysis of the proportion of patients<br>•Screened that are eligible<br>•Eligible that are enrolled<br>•Lost to follow-up or withdraw from the trial<br>•Receive their allocated treatment throughout their trial participation<br>•Missing data during trial data collection<br>[12 months post transplant]
- Secondary Outcome Measures
Name Time Method