A vanguard multicentre, step wedged cluster randomised trial to assess the tolerability of plasmapheresis versus whole blood in first time donors before expansion to a national roll out

Australian Red Cross Blood Service0 个研究点目标入组 3,035 人开始时间: 2016年9月19日最近更新: 2021年1月5日

适应症

试验速览

暂无简介。

•Cluster (Blood Collection Centre)
•Inclusion Criteria
•1. Sufficient size to recruit 20 new donors a month over a 6- 7 month period and
•2. a historical measure over a 18 month period (1/1/2014 to 31/06/2015) of
•a) Greater than 10% first time whole blood donors converted to plasma
•b) Greater than a 60% return rate for plasma to plasma donations
•c) Greater than a 55% total retention rate for all donation types (WB, PLS, PLT)
•Participant (Blood Donor)
•Inclusion Criteria
•1. Adults 30 years or over and less than 71 years
•2. New Donor (someone who has never registered to donate)
•3. Generally eligible for blood donation as per the current GSBD
•4. Written consent for General Donation and written consent for Apheresis for plasma

•Cluster (Blood Collection Centre)
•Exclusion Criteria
•1. Participation in another research study (R&D or Marketing) that may interfere with donor
•recruitment and the outcomes under investigation
•2. Donor Services Leadership team consider the donor centre not appropriate for participation (e.g.: centre undergoing renovations, relocation)
•Participant (Blood Donor)
•Exclusion Criteria
•1. Not eligible for any type of blood donation as per the current Guidelines for Selection of Blood Donors (GSBD)
•2. Participation in a concurrent interventional medical investigation or clinical trial. Participants in observational, natural history and/ or epidemiological studies not involving an intervention are eligible. Participation in another Blood Service study at the time of donation is not permitted.
•3. Vein unable to be palpated under pressure (BP cuff, tourniquet) during interview and in
•donation chair

发起方