NCT04355130: ATREMA

Autologous Tansfusion REquirements in Bone MArrow Harvest: The ATREMA Study

Completed Last updated 16 February 2023

What this trial tests

trial testing Iron, vitamin B12 and acid folic supplementation in Bone Marrow Donors in 7 participants. Completed in 20 December 2022.

Timeline

20 March 2020

Primary endpoint
20 December 2022

20 December 2022

Quick facts

Lead sponsor	Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Status	Completed
Study type	OBSERVATIONAL
Enrollment	7
Start date	20 March 2020
Primary completion	20 December 2022
Estimated completion	20 December 2022
Sites	1 location across Italy

Drugs / interventions tested

• Iron, vitamin B12 and acid folic supplementation

Conditions studied

• Bone Marrow Donors — all drugs for Bone Marrow Donors →

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Who can join

Eligibility, any sex, with Bone Marrow Donors. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Autologous transfusion requirements in bone marrow harvest: results of the ATREMA study.
   Valentini CG, Innocenti I, Pellegrino C, Draisci G, et al · · 2024 · cited 1× · PMID 38276912 · DOI 10.2450/bloodtransfus.669