N/A
N=7
Evaluation of the Spectra Optia PMN Cell Collection Procedure
Granulocyte/ Polymorphonuclear Cells
Bottom Line
View on ClinicalTrials.gov: NCT01805180 ↗Enrolled (actual)
7
Serious AEs
0.0%
Results posted
Nov 2014
Primary outcome: Primary: Granulocyte/PMN Cell Collection Efficiency — 54.7; 52.4; 41.9; 44.7 percent cells processed
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Granulocyte/Polymorphonuclear Cell Collection (COBE Spectra System) (Device); Granulocyte/Polymorphonuclear Cell Collection (Spectra Optia System) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Terumo BCT
- Primary completion
- Jul 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Granulocyte/PMN Cell Collection Efficiency |
54.7; 52.4; 41.9; 44.7 | — |
| SECONDARY Performance |
56.6; 55.4; 44.0; 46.9; 11.2; 10.4 | — |
| SECONDARY Characterization of Blood Product - PMN Cell Yield |
1.4; 1.4; 1.1; 1.2 | — |
| SECONDARY Characterization of Blood Product - PMN Cell Yield Per Liter of Blood Processed |
1.4; 1.4; 1.1; 1.2 | — |
| SECONDARY Characterization of the Blood Product - PMN Cell Viability |
99.6; 99.6; 99.6; 99.2 | — |
| SECONDARY Characterization of the Blood Product - RBC Contamination |
7.4; 7.5 | — |
| SECONDARY Characterization of the Blood Product - Volume |
472.6; 471.9; 329.7; 298.5 | — |
| SECONDARY Usability/Assessment of System Operation - Time |
136.8; 120.3; 119.6; 112.3 | — |
| SECONDARY Usability/Assessment of System Operation - Adjustments |
4.6; 5.8; 9.3; 10.7 | — |
| SECONDARY Usability/Assessment of System Operation - Device Malfunctions |
5; 0 | — |
| SECONDARY Safety |
0; 0; 0; 0; 17 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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 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.
- History of deep vein thrombosis or venous thromboembolism, or bleeding disorder.
- History of sickle cell disease or a positive SickleDex screen.
- History of iritis or episcleritis.
- History of autoimmune condition or disorder, unless approved by principal investigator.
- Presence of psychological traits, or physiological or medical conditions that, in the opinion of the investigator, would make the subject unlikely to tolerate the procedures or complete the study.
- History of use/anticipated need for lithium.
- Received a G-CSF injection in the prior 4 months.
- Known hypersensitivity to ethylene oxide.
- Known hypersensitivity to G-CSF or hypersensitivity to any E. coli-derived products.
- Known hypersensitivity to HES or corn.
- Concurrent participation in another clinical trial or participation in a clinical trial within the past 30 days.
- Subject is being treated with calcium channel blockers and/or antiepileptic medications. Note: This applies only to Subjects at Bonfils Blood Center whose collected product will undergo neutrophil function testing.
Data sourced from ClinicalTrials.gov (NCT01805180). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.