Autologous Tansfusion REquirements in Bone MArrow Harvest: The ATREMA Study

Study Overview
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Brief Summary
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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.

Official Title
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Autologous Tansfusion REquirements in Bone MArrow Harvest: The ATREMA Study

Conditions
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Bone Marrow Donors

Intervention / Treatment
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* Dietary Supplement: Iron, vitamin B12 and acid folic supplementation


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: Iron, vitamin B12 and acid folic supplementation|Vitamin and iron supplementation is administered one-two weeks before donation, and consist of iron supplementation (i.v. infusion of 20 mg/Kg ferric carboxymaltose in saline 100 ml), s.c. injection of 1 mg of vitamin B12 and acid folic 5 mg/die per os until day +15 post BM donation. BM collection is carried out by the transplant team and a maximal dose of 20-22 ml/Kg of the donor body weight is collected under general anesthesia (induction with fentanyl 1-3 mcg/Kg, Propofol 2-3 mg/Kg, rocuronium 0,6 mg/Kg and mantenaince with sevoflurane 0,8 MAC). Noninvasive cardiac output, blood pressure and hemoglobin monitoring are carried out during the entire procedure and in in the recovery room using the ClearSight™ system (Edwards Clinical) and the Radical Pulse co oxymeter (Masimo). After discharge from the hospital, donors will be revaluated on day + 7 after BM collection, and blood tests will be repeated in outpatient setting.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hb values | Hb values recorded in healthy BM donors receiving iron and vitamins supplementation at the end of BM harvest | during procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hb values | Hb values recorded in healthy BM donors receiving iron and vitamins supplementation at day 1 after BM harvest | day 1 post BM harvest | 
| Hb values | Hb values recorded in healthy BM donors receiving iron and vitamins supplementation at day 7 after BM harvest | day 7 post BM harvest |