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Evaluation of the Spectra Optia PMN Cell Collection Procedure | Clinical Trials | Clareo Health

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Evaluation of the Spectra Optia PMN Cell Collection Procedure

A Controlled Evaluation of the Spectra Optia® Apheresis System's Granulocyte / Polymorphonuclear (PMN) Cell Collection Procedure

NCT01805180•Terumo BCT

View on ClinicalTrials.gov

Summary

The purpose of this study is to compare the procedures for the collection PMN cells on Terumo BCT's Spectra Optia® and COBE® Spectra Apheresis Systems.

Detailed Description

The purpose of this study is to compare the procedures for the collection of granulocyte/ polymorphonuclear (PMN) cells on Terumo BCT's Spectra Optia® and COBE® Spectra Apheresis Systems and to establish the non-inferiority of the Spectra Optia Apheresis System with respect to the primary study endpoint, granulocyte/PMN cell collection efficiency.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Acceptable health status and vital signs per the AABB blood donation guidelines to permit blood donation, including:
•1. Blood pressure ≥ 90/50 and ≤ 200/120 mmHg,
•2. Pulse \> 40 and \< 100 beats/min, and
•3. Temperature \< 99.5ºFahrenheit (F).
•Able to read, understand, and sign an English informed consent form.
•Age ≥ 18 years.
•Weight ≥ 50kg and \< 227kg.
•Male or non-pregnant, non-nursing female (a negative serum pregnancy test at screening and a negative urine pregnancy test prior to each mobilization).
•Acceptable screening laboratory test results prior to the first PMN cell mobilization, including:
•1. WBC count in the range: 3,500-10,800/uL,
+9 more criteria

Exclusion Criteria

•Positive screening for any of the following: HIV, HBV (except isolated HB core Ab reactivity), HCV, HTLV, Syphilis or West Nile Virus.
•Currently pregnant or breast-feeding.
•Collection or loss of specific volumes of whole blood or blood components during specified timeframes:
•1. more than 550mL of whole blood within the prior 56 days, or
•2. more than 3L of whole blood or 1.5L of red blood cells within the prior 12 months, or
•3. more than 12L of plasma within the prior 12 months, or
•4. a leukapheresis within the prior six weeks, or
•5. a plateletpheresis within the prior 48 hours or two within the prior 7 days or twenty-four within the last 12 months, or
•6. a plasmapheresis within the prior 48 hours or two within the prior 7 days.
•History of congestive heart failure.
+17 more criteria

Locations (3)

Bonfils Blood Center

Denver, Colorado, United States

Hoxworth Blood Center

Cincinnati, Ohio, United States

Blood Centers of Wisconsin

Milwaukee, Wisconsin, United States

Key Dates

Start Date

February 1, 2013

Primary Completion Date

July 1, 2013

Completion Date

July 1, 2013

Last Updated

March 18, 2015

Enrollment

ACTUAL participants

Conditions

Granulocyte/ Polymorphonuclear Cells

Interventions

Granulocyte/Polymorphonuclear Cell Collection (COBE Spectra System)

DEVICE

Granulocyte/Polymorphonuclear Cell Collection (Spectra Optia System)

DEVICE