HAbIT Part 1: Incidence of De novo HLA Antibody formation after Transfusion with blood products in patients with end stage kidney disease who are planned for live donor kidney transplant: A prospective study

Australian Red Cross Blood Service0 个研究点目标入组 155 人开始时间: 2018年2月20日最近更新: 2024年4月15日

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•5.2.1Inclusion criteria
•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
•c)Transfusion must occur in a hospital setting (including satellite dialysis units)
•d)Anticipated to be able to provide a further blood sample 6-8 weeks post-transfusion
•e) CKD patient, ESKD patient, or other patient with renal disease, potentially eligible for live donor transplant as per local site transplant unit protocol
•f) > 18 years of age
•g) Not pregnant

•a) Blood transfusion in 6 weeks prior to enrolment, or anticipated need for further transfusion in less than 6 weeks after the study transfusion event
•b) Immunoglobulin therapy within 6 months prior to enrolment or scheduled within 4 weeks after enrolment (for treatments scheduled 6-8 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 6-8 weeks after transfusion
•d) Pre-existing requirement for specific red cell product (eg directed donation)
•e) Urgent transfusion (in the opinion of the investigator, delay in the transfusion for enrolment would compromise patient care)
•f) Use of biologic medications targeting immune cells in 12 months prior to the trial (eg rituximab, bortezomib), or anticipated use of these medications in the 4 weeks post-transfusion (for treatments scheduled 6-8 weeks after enrolment the post-transfusion sample can be taken immediately prior to the treatment)

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