Clinical Investigational Protocol for 2 RBC Single Unit Recovery on MCS®+ 8150 Using LN832 Disposable Sets (US)
|ClinicalTrials.gov Identifier: NCT01764061|
Recruitment Status : Completed
First Posted : January 9, 2013
Last Update Posted : October 11, 2013
|Condition or disease|
|Red Blood Cell Donation|
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:
- Hemolysis of less than or equal to 1% at 42 days of storage
- Maximum absolute red cell volume is less than or equal to the programmed absolute RBC target volume + 15%
- 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.
|Study Type :||Observational|
|Actual Enrollment :||60 participants|
|Official Title:||Clinical Investigational Protocol for 2 RBC Single Unit Recovery on MCS®+ 8150 Using LN832 Disposable Sets (US)|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||September 2013|
- Hemolysis level at 42 days of storage [ Time Frame: 42 days ]
- Absolute red cell volume [ Time Frame: 42 days ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01764061
|United States, Virginia|
|American Red Cross|
|Norfolk, Virginia, United States, 23507|
|United States, Wisconsin|
|Blood Center of Wisconsin|
|Milwaukee, Wisconsin, United States, 53233|
|Principal Investigator:||Lou Anne Young Maes, MD||American National Red Cross|
|Principal Investigator:||Jerome Gottschall, MD||Blood Center of Wisconsin|