NCT01764061

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2013

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 4, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 9, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

October 11, 2013

Status Verified

October 1, 2013

Enrollment Period

8 months

First QC Date

January 4, 2013

Last Update Submit

October 9, 2013

Conditions

Red Blood Cell Donation

Keywords

Red CellsBlood donors

Outcome Measures

Primary Outcomes (2)

  • Hemolysis level at 42 days of storage

    42 days

  • Absolute red cell volume

    42 days

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy blood donors

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

American Red Cross

Norfolk, Virginia, 23507, United States

Location

Blood Center of Wisconsin

Milwaukee, Wisconsin, 53233, United States

Location

Study Officials

  • Lou Anne Young Maes, MD

    American National Red Cross

    PRINCIPAL INVESTIGATOR

  • Jerome Gottschall, MD

    Versiti Blood Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2013

First Posted

January 9, 2013

Study Start

January 1, 2013

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

October 11, 2013

Record last verified: 2013-10

Locations

US(2)