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

Red Blood Cell Donation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01764061
• Other study ID #: TP-CLN-100067
• Status: Completed
• Phase: N/A
• First received: January 4, 2013
• Last updated: October 9, 2013
• Start date: January 2013
• Est. completion date: September 2013

Study information

• Verified date: October 2013
• Source: Haemonetics Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Red Blood Cell Donation

Locations

Country	Name	City	State
United States	Blood Center of Wisconsin	Milwaukee	Wisconsin
United States	American Red Cross	Norfolk	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Haemonetics Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemolysis level at 42 days of storage		42 days	No
Primary	Absolute red cell volume		42 days	No