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

This study is currently recruiting participants.
Verified January 2013 by Haemonetics Corporation
Sponsor:
Information provided by (Responsible Party):
Haemonetics Corporation
ClinicalTrials.gov Identifier:
NCT01764061
First received: January 4, 2013
Last updated: January 22, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition
Red Blood Cell Donation

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Clinical Investigational Protocol for 2 RBC Single Unit Recovery on MCS®+ 8150 Using LN832 Disposable Sets (US)

Further study details as provided by Haemonetics Corporation:

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 ]

Estimated Enrollment: 131
Study Start Date: January 2013
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Detailed Description:

This study will take place at two sites (Blood Center of Wisconsin (BCW) Milwaukee, WI and American Red Cross-Norfolk, VA).

  • A standard double red cell collection protocol will be initiated using the Haemonetics MCS®+ 8150 system using LN832 disposable sets. The collection procedure will be terminated after collection of one RBC unit. The maximum target red cell volume will be selected based on the donor predonation weight as specified in the nomogram included in the MCS®+ 8150 operation manual.
  • The RBC units will be stored for 42 days at 1° to 6°C.
  • Upon collection and at 42 days after collection, the RBC units will be weighed and tested for hematology parameters (white blood cell count, red blood cell count, residual white blood cell count, hemoglobin, hematocrit, platelet count, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, red blood cell distribution width, and supernatant hemoglobin) and chemistry parameters (pH, potassium, glucose, lactate, and ATP).

  • Acceptance criteria for this study are as follows:

    1. Hemolysis of less than or equal to 1% at 42 days of storage
    2. Maximum absolute red cell volume is less than or equal to the programmed absolute RBC target volume + 15%
    3. Minimum absolute red cell volume is greater than or equal to the programmed absolute RBC target volume - 15%
  • After collection of sixty (60) evaluable RBC units, the study will be considered supportive of the intended use noted above if zero (0) units fail the acceptance criteria.
  • If one (1) unit fails acceptance criteria after collection of sixty (60) evaluable RBC units, an additional seventy one (71) units will be collected.
  • The study will be considered supportive of the intended use noted above if not more than one (1) total unit out of 131 evaluable units fails the acceptance criteria.
  • If a total of two (2) units fail acceptance criteria, the study will not be considered supportive of the intended use noted above.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Healthy blood donors

Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • will be not fulfilling any of the inclusion criteria.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01764061

Contacts
Contact: Lawrence W. Yarmaloff (508) 620 2293 lyarmaloff@Haemonetics.com
Contact: Adrian Orr (781) 356-9647 aorr@haemonetics.com

Locations
United States, Virginia
American Red Cross Recruiting
Norfolk, Virginia, United States, 23507
Contact: Lou Anne Young Maes, MD     757-446-7746     maesl@usa.redcross.org    
Contact: Pamela H. Whitley, MS     (757) 446-7720     whitleyp@usa.redcross.org    
Principal Investigator: Lou Anne Young Maes, MD            
United States, Wisconsin
Blood Center of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53233
Contact: Jerome Gottschall, MD     414-937-6231     mailto:Jerry.gottscall@bcw.edu    
Contact: Sharon Graminske     414-937-6295     Sharon.graminske@bcw.edu    
Principal Investigator: Jerome Gottschall, MD            
Sponsors and Collaborators
Haemonetics Corporation
Investigators
Principal Investigator: Lou Anne Young Maes, MD American Red Cross
Principal Investigator: Jerome Gottschall, MD Blood Center of Wisconsin
  More Information

No publications provided

Responsible Party: Haemonetics Corporation
ClinicalTrials.gov Identifier: NCT01764061     History of Changes
Other Study ID Numbers: TP-CLN-100067
Study First Received: January 4, 2013
Last Updated: January 22, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Haemonetics Corporation:
Red Cells
Blood donors

ClinicalTrials.gov processed this record on May 16, 2013