Autologous Tansfusion REquirements in Bone MArrow Harvest: The ATREMA Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Outcome Measures
Primary Outcome Measures
- 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
- Hb values [day 1 post BM harvest]
Hb values recorded in healthy BM donors receiving iron and vitamins supplementation at day 1 after BM harvest
- 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
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fondazione Policlinico Universitario A. Gemelli IRCCS | Roma | RM | Italy | 00168 |
Sponsors and Collaborators
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Investigators
- Principal Investigator: Luciana Teofili, Fondazione Policlinico Universitario A. Gemelli, IRCCS
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2916