Autologous Tansfusion REquirements in Bone MArrow Harvest: The ATREMA Study (ATREMA)

February 14, 2023 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

7

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • RM
      • Roma, RM, Italy, 00168
        • Fondazione Policlinico Universitario A. Gemelli IRCCS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

To collect data on BM harvest in healthy donors who don't have PAD collected. We expect that no allogeneic transfusions are required and that Hb levels after collection are similar to those recorded in our historical cohort receiving 1 or 2 PAD.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2020

Primary Completion (Actual)

December 20, 2022

Study Completion (Actual)

December 20, 2022

Study Registration Dates

First Submitted

April 14, 2020

First Submitted That Met QC Criteria

April 17, 2020

First Posted (Actual)

April 21, 2020

Study Record Updates

Last Update Posted (Estimate)

February 16, 2023

Last Update Submitted That Met QC Criteria

February 14, 2023

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2916

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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