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

October 9, 2013 updated by: Haemonetics Corporation
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • American Red Cross
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53233
        • Blood Center of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Healthy blood donors

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Hemolysis level at 42 days of storage
Time Frame: 42 days
42 days
Absolute red cell volume
Time Frame: 42 days
42 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Haemonetics Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lou Anne Young Maes, MD, American National Red Cross
  • Principal Investigator: Jerome Gottschall, MD, Versiti

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 4, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 9, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 11, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TP-CLN-100067

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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