Autologous Tansfusion REquirements in Bone MArrow Harvest: The ATREMA Study

Bone Marrow Donors Clinical Trial

— ATREMA  

Official title:

Autologous Tansfusion REquirements in Bone MArrow Harvest: The ATREMA Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04355130
• Other study ID #: 2916
• Status: Completed
• Start date: March 20, 2020
• Est. completion date: December 20, 2022

Study information

• Verified date: March 2022
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: December 20, 2022
• Est. primary completion date: December 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Bone Marrow Donors

Intervention

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.

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Universitario A. Gemelli IRCCS	Roma	RM

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hb values	Hb values recorded in healthy BM donors receiving iron and vitamins supplementation at the end of BM harvest	during procedure
Secondary	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
Secondary	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