Autologous Tansfusion REquirements in Bone MArrow Harvest: The ATREMA Study

Completed

• Conditions: Bone Marrow Donors

• Registration Number: NCT04355130
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-20
• Study First Submitted: 2020-04-14
• Study First Submitted QC: 2020-04-17
• Study First Posted: 2020-04-21
• Status Verified: 2022-03
• Primary Completion: 2022-12-20
• Study Completion: 2022-12-20
• Last Update Submitted: 2023-02-14
• Last Update Posted: 2023-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

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

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hb values	during procedure	Hb values recorded in healthy BM donors receiving iron and vitamins supplementation at the end of BM harvest

Secondary Outcome Measures

Name	Time	Method
Hb values	day 7 post BM harvest	Hb values recorded in healthy BM donors receiving iron and vitamins supplementation at day 7 after BM harvest

Trial Locations

Locations (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS; 🇮🇹 Roma, RM, Italy