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

Completed

Conditions studied: Red Blood Cell Donation

In brief

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.

Key facts

Study ID

NCT01764061

Run by

Haemonetics Corporation

People needed

60

Starts

2013-01-01

Expected to finish

2013-09-01

Last updated by the study team

2013-10-11

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Males and Females ≥ 18 years of age
• Males ≥ 130 pounds, Females ≥ 150 pounds
• Males ≥ 5 feet, 1 inch, Females ≥ 5 feet, 3 inches
• Hemoglobin ≥ 13.3 g/dL
• Hematocrit ≥ 40%
• Donor Eligibility: Meets all criteria as per sites' Research Blood Donation Record, Prior donation date (i.e. not less than 112 days for most recent double RBC unit donation, 56 days for most recent single RBC unit donation)
• Subject must provide informed consent using an IRB informed consent form prior to undergoing any study related procedures.

You may not qualify if…

• will be not fulfilling any of the inclusion criteria.

Where it is running

• American Red Cross — Norfolk, Virginia, United States
• Blood Center of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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