Clinical Investigational Protocol for 2 RBC Single Unit Recovery on MCS®+ 8150 Using LN832 Disposable Sets (US)
This study has been completed.
Information provided by (Responsible Party):
First received: January 4, 2013
Last updated: October 9, 2013
Last verified: October 2013
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.
||Time Perspective: Prospective
||Clinical Investigational Protocol for 2 RBC Single Unit Recovery on MCS®+ 8150 Using LN832 Disposable Sets (US)
Primary Outcome Measures:
- Hemolysis level at 42 days of storage [ Time Frame: 42 days ] [ Designated as safety issue: No ]
- Absolute red cell volume [ Time Frame: 42 days ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||September 2013 (Final data collection date for primary outcome measure)
This study will take place at two sites (Blood Center of Wisconsin (BCW) Milwaukee, WI and American Red Cross-Norfolk, VA).
|Ages Eligible for Study:
||18 Years to 65 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- will be not fulfilling any of the inclusion criteria.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01764061
|American Red Cross
|Norfolk, Virginia, United States, 23507 |
|Blood Center of Wisconsin
|Milwaukee, Wisconsin, United States, 53233 |
||Lou Anne Young Maes, MD
||American Red Cross
||Jerome Gottschall, MD
||Blood Center of Wisconsin
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 4, 2013
||October 9, 2013
||United States: Food and Drug Administration
Keywords provided by Haemonetics Corporation:
ClinicalTrials.gov processed this record on August 26, 2014