Evaluation of the Spectra Optia PMN Cell Collection Procedure

NCT01805180 | Completed Results

• 1 other identifier: CTS-5010
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Granulocyte/ Polymorphonuclear Cells

Outcome Measures

Primary Outcomes (1)

• Granulocyte/PMN Cell Collection Efficiency

  The primary endpoint is the granulocyte/PMN cell collection efficiency (CE) associated with the Granulocyte (PMN) Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems. CE is a measurement of device performance calculated using donor and blood product blood counts collected immediately before and after the PMN collection procedure.

  within 1 hour prior and within 5 minutes after each collection procedure

Secondary Outcomes (10)

• Performance

  within 1 hour prior and within 5 minutes after each collection procedure

• Characterization of Blood Product - PMN Cell Yield

  within 5 minutes after each collection procedure

• Characterization of Blood Product - PMN Cell Yield Per Liter of Blood Processed

  within 5 minutes after each collection procedure

• Characterization of the Blood Product - PMN Cell Viability

  within 5 minutes after collection procedure

• Characterization of the Blood Product - RBC Contamination

  within 5 minutes after collection procedure

Study Arms (2)

Arm 1: Spectra Optia followed by COBE Spectra

OTHER

Controlled evaluation of Granulocyte/Polymorphonuclear Cell Collection on the Spectra Optia device followed by the COBE Spectra device.

Device: Granulocyte/Polymorphonuclear Cell Collection (COBE Spectra System); Device: Granulocyte/Polymorphonuclear Cell Collection (Spectra Optia System)

Arm 2: COBE Spectra followed by Spectra Optia

OTHER

Controlled evaluation of Granulocyte/Polymorphonuclear Cell Collection on the COBE Spectra device followed by Spectra Optia.

Device: Granulocyte/Polymorphonuclear Cell Collection (COBE Spectra System); Device: Granulocyte/Polymorphonuclear Cell Collection (Spectra Optia System)

Interventions

Granulocyte/Polymorphonuclear Cell Collection (COBE Spectra System) DEVICE

In Arm 1 the first PMN cell collection will be performed using the Spectra Optia System and the second PMN cell collection using the COBE Spectra System.

Arm 1: Spectra Optia followed by COBE Spectra; Arm 2: COBE Spectra followed by Spectra Optia

Granulocyte/Polymorphonuclear Cell Collection (Spectra Optia System) DEVICE

In Arm 2 the first PMN cell collection will be performed using the COBE Spectra System and the second PMN cell collection using the Spectra Optia System.

Arm 1: Spectra Optia followed by COBE Spectra; Arm 2: COBE Spectra followed by Spectra Optia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Acceptable health status and vital signs per the AABB blood donation guidelines to permit blood donation, including:
• Blood pressure ≥ 90/50 and ≤ 200/120 mmHg,
• Pulse \> 40 and \< 100 beats/min, and
• 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:
• WBC count in the range: 3,500-10,800/uL,
• Hematocrit in the range: 38-65%,
• Platelet count in the range: 150,000-400,000/uL,
• Coagulation tests: PT not greater than 1.1 times the upper limit of the local laboratory reference range; PTT not greater than 1.2 times the upper limit of the local laboratory reference range,
• Serum electrolyte concentrations: potassium in the range 3.6-5.1 mmol/L; calcium in the range 8.5-10.3 mg/dL,
• Serum creatinine not greater than 1.5mg/dL, and

You may not qualify if:

• 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:
• more than 550mL of whole blood within the prior 56 days, or
• more than 3L of whole blood or 1.5L of red blood cells within the prior 12 months, or
• more than 12L of plasma within the prior 12 months, or
• a leukapheresis within the prior six weeks, or
• a plateletpheresis within the prior 48 hours or two within the prior 7 days or twenty-four within the last 12 months, or
• a plasmapheresis within the prior 48 hours or two within the prior 7 days.
• History of congestive heart failure.
• History of uncontrolled hypertension (SBP/DBP \>200/120 mmHg).
• History or suspicion of active, peptic ulcer disease.
• History of diabetes mellitus.
• History of hematologic malignancy or chronic hematologic disorder.
• Family history (parents, siblings, children) of hematologic malignancy.

Sponsors & Collaborators

• Terumo BCT: lead

Study Sites (3)

Bonfils Blood Center

Denver, Colorado, 80230, United States

Location

Hoxworth Blood Center

Cincinnati, Ohio, 45267-0055, United States

Location

Blood Centers of Wisconsin

Milwaukee, Wisconsin, 53233, United States

Location

Limitations and Caveats

The Full Analysis Set included 32 subjects who completed both procedures of the cross-over study design presented here. Two subjects did not meet pre-defined criteria for evaluable and 30 subjects were included in the Evaluable Analysis Population.

Results Point of Contact

• Title: Raymond P. Goodrich, PhD / VP, Scientific and Clinical Affairs; Chief Science Officer-BBT
• Organization: Terumo BCT

Ray.Goodrich@terumobct.com

303.205.2680

Study Officials

• Raymond Goodrich, Ph.D

  Terumo BCT

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2013
• First Posted: March 6, 2013
• Study Start: February 1, 2013
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: March 18, 2015
• Results First Posted: November 26, 2014

Record last verified: 2015-02

Locations

US (3)