ACTRN12619000163101已完成未知
HAbIT Part 3: Incidence of De novo HLA Antibody formation after Transfusion with blood products in patients requiring transfusion: A prospective, double-blinded, randomised controlled trial of red cell transfusion from donors selected to maximise HLA compatibility.
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 142
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
- Years 至 o limit（—）
- 性别
- All
入选标准
- •a) Eligible for blood transfusion according to local site clinical guidelines and anticipated to require a red cell transfusion on clinical grounds by participating unit
- •b)Patient assessed as competent to consent and participate or has a competent parent or guardian for paediatric participants
- •c)Transfusion must occur in a hospital setting (including satellite dialysis units)
- •d)Anticipated to be able to provide a further blood sample 4-8 weeks post-transfusion
- •e Patients younger than 18 years of age may be recruited from paediatric hospital sites only
- •f) Not pregnant
排除标准
- •a) Blood transfusion in 4 weeks prior to enrolment or anticipated need for further transfusion in less than 4 weeks after the study transfusion event.
- •b) Immunoglobulin therapy within 6 months prior to enrolment or scheduled within 6 weeks after enrolment (for treatments scheduled 4-8 weeks after enrolment the post-transfusion sample can be taken immediately prior to the treatment)
- •c) Severe illness that, in the opinion of the investigator, would compromise the ability of the subject to undergo further blood tests 4-8 weeks after transfusion
- •d) Pre-existing requirement for specific red cell product (e.g. directed donation) or non red cell blood product (e.g. platelets, fresh frozen plasma)). For paediatric patients only, patients requiring plasma products in addition to the red cell transfusion may be enrolled at the discretion of the investigator.
- •e) Urgent transfusion (such that, in the opinion of the site investigator, delay in the transfusion for enrolment and provision of the intervention product would compromise patient care)
- •f) Use of relevant (in the opinion of the investigator) biologic medications targeting immune cells, that in the opinion of the investigator would affect the outcome of the trial, in 12 months prior to the trial (e.g. rituximab, bortezomib), or anticipated use of these medications in the 4 weeks post-transfusion.
- •g) Hyperkalaemia prior to transfusion (i.e. serum potassium elevated sufficiently above the local site laboratory reference range to increase the risk associated with an irradiated transfusion, according to the investigator) or anticipated need for >4 units
- •h) Pregnant patient
- •i) Previous bone marrow allograft or haematological malignancy that could affect the primary outcome, in the opinion of the investigator
- •j) Patient at risk of Transfusion-associated Graft-Versus-Host Disease (TA-GVHD) under Australian and New Zealand Society of Blood Transfusion guidelines, and/or deemed by treating clinical team to require irradiated red cells only (for adult patients only)
研究者
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