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Clinical Investigational Protocol for 2 RBC Single Unit Recovery on MCS®+ 8150 Using LN832 Disposable Sets (US)

NCT01764061 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2013-10-11

No results posted yet for this study

Summary

The purpose of this study is to validate that single units of RBCs collected by the Haemonetics MCS®+ 8150 system using LN832 disposable sets during an interrupted double red cell collection protocol meet all in vitro FDA requirements for non-leukoreduced red blood cells, and to provide data to support the 510(k) clearance of the MCS®+ 8150 system using LN832 disposable sets for this intended use.

Conditions

  • Red Blood Cell Donation

Sponsors & Collaborators

  • Haemonetics Corporation

    lead INDUSTRY

Principal Investigators

  • Lou Anne Young Maes, MD · American National Red Cross

  • Jerome Gottschall, MD · Versiti

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2013-09-30
Completion
2013-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01764061 on ClinicalTrials.gov