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Clinical Trials/ACTRN12618001394235
ACTRN12618001394235
Recruiting
未知

A Randomised Double-blind Placebo-controlled Pilot Study of Intravenous Immunoglobulin Replacement therapy in Lung Transplantation

The Alfred Hospital0 sites40 target enrollmentAugust 20, 2018

Overview

Phase
未知
Intervention
Not specified
Conditions
Transplantation
Sponsor
The Alfred Hospital
Enrollment
40
Status
Recruiting
Last Updated
5 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 20, 2018
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
The Alfred Hospital

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Not specified

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