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临床试验/ACTRN12618001394235
ACTRN12618001394235招募中未知

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

The Alfred Hospital0 个研究点目标入组 40 人开始时间: 2018年8月20日最近更新:
适应症

试验速览

阶段
未知
状态
招募中
发起方
入组人数
40

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Treatment
盲法
Blinded (masking used)

入排标准

年龄范围
18 Years 至 o limit(—)
性别
All

入选标准

  • 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

排除标准

  • 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

研究者

发起方
The Alfred Hospital

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