跳至主要内容
临床试验/NCT04355130
NCT04355130已完成不适用

Autologous Tansfusion REquirements in Bone MArrow Harvest: The ATREMA Study

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2020年3月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
7
试验地点
1
主要终点
Hb values

研究概览

简要总结

Despite perioperative autologous donation (PAD) is widely used in healthy bone marrow (BM) donors to restrain the hemoglobin decrease after BM harvest, this practice is not supported by strong clinical evidences and has been abandoned by some transplant teams. The critical revision of data relative to 102 BM collection procedures performed at our center between 2014 and 2018 failed to demonstrate an advantage of 1 over 2 PAD. Conversely, clearly emerged that PAD reduce the hemoglobin levels at BM harvest. Basically, PAD practice consists in the transfer of RBCs from the subject into a plastic bag and back to the subject at BM harvesting. Indeed, the evidence of clinical benefits of PAD in BM donors are still elusive. For this reason, current procedures on unrelated donors recommend iron and vitamin supplementation before the BM harvest, but let the decision to perform or not PAD at collection centers. Detailed data on the safety and feasibility of BM harvest procedures in absence of PAD have been rarely reported. The investigators collect data on BM harvest in healthy donors who don't have PAD collected. The investigators expect that no allogeneic transfusions are required and that Hb levels after collection are similar to those recorded in the historical cohort gathered at the same center receiving 1 or 2 PAD.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Familial donors qualified to donate BM hematopoietic stem cells and accepting to participate to this study

排除标准

  • Any planned deviation connected with abnormalities in the health status and/or laboratory tests of the donor, even though it does not prevent him from donation.

结局指标

主要结局

Hb values

时间窗: during procedure

Hb values recorded in healthy BM donors receiving iron and vitamins supplementation at the end of BM harvest

次要结局

  • Hb values(day 7 post BM harvest)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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