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Clinical trialNCT01764061CompletedObservational

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

SponsorHaemonetics CorporationEnrollment60Red Blood Cell Donation
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.
clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

2 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • American Red Cross

    Norfolk, Virginia, United States

  • Blood Center of Wisconsin

    Milwaukee, Wisconsin, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
31 Jan 2013
Primary completion
30 Sept 2013
Completion
30 Sept 2013
Last update posted
11 Oct 2013
Registered enrollment
60
Registry id
NCT01764061
clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 11 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.