Autologous Tansfusion REquirements in Bone MArrow Harvest: The ATREMA Study

CompletedOBSERVATIONAL
Enrollment

7

Participants

Timeline

Start Date

March 20, 2020

Primary Completion Date

December 20, 2022

Study Completion Date

December 20, 2022

Conditions
Bone Marrow Donors
Interventions
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.

Trial Locations (1)

00168

Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma

All Listed Sponsors
lead

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

NCT04355130 - Autologous Tansfusion REquirements in Bone MArrow Harvest: The ATREMA Study | Biotech Hunter | Biotech Hunter