Trial Outcomes & Findings for Evaluation of the Spectra Optia PMN Cell Collection Procedure (NCT NCT01805180)
NCT ID: NCT01805180
Last Updated: 2015-03-18
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
42 participants
Primary outcome timeframe
within 1 hour prior and within 5 minutes after each collection procedure
Results posted on
2015-03-18
Participant Flow
Subjects were recruited from the specialized donor population of blood centers from February 2013 - July 2013.
A screening period was used to evaluate and confirm eligibility criteria prior to enrollment \& randomization to treatment assignment (Arm 1 or Arm 2). Fifty subjects consented to the pivotal study. Eight pivotal subjects consented but screen failed prior to treatment assignment. Forty-two received treatment assignment below.
Participant milestones
| Measure |
Lead-in Donor
Subjects screened and enrolled for the purpose of training on the investigational procedure only. Included in safety analysis only.
|
Arm 1 - Spectra Optia Followed by COBE Spectra PMN
Healthy donors who were consented to participate in the pivotal trial and were randomized to receive the PMN collection procedure on the Spectra Optia first, followed by the COBE Spectra.
|
Arm 2 - COBE Spectra Followed by Spectra Optia PMN
Healthy donors who were consented to participate in the pivotal trial and were randomized to receive the PMN collection procedure on the COBE Spectra first, followed by the Spectra Optia.
|
|---|---|---|---|
|
Lead-in Donor Phase
STARTED
|
7
|
0
|
0
|
|
Lead-in Donor Phase
COMPLETED
|
6
|
0
|
0
|
|
Lead-in Donor Phase
NOT COMPLETED
|
1
|
0
|
0
|
|
Pivotal Randomization Through Study Exit
STARTED
|
0
|
22
|
20
|
|
Pivotal Randomization Through Study Exit
COMPLETED
|
0
|
17
|
15
|
|
Pivotal Randomization Through Study Exit
NOT COMPLETED
|
0
|
5
|
5
|
Reasons for withdrawal
| Measure |
Lead-in Donor
Subjects screened and enrolled for the purpose of training on the investigational procedure only. Included in safety analysis only.
|
Arm 1 - Spectra Optia Followed by COBE Spectra PMN
Healthy donors who were consented to participate in the pivotal trial and were randomized to receive the PMN collection procedure on the Spectra Optia first, followed by the COBE Spectra.
|
Arm 2 - COBE Spectra Followed by Spectra Optia PMN
Healthy donors who were consented to participate in the pivotal trial and were randomized to receive the PMN collection procedure on the COBE Spectra first, followed by the Spectra Optia.
|
|---|---|---|---|
|
Lead-in Donor Phase
screen failure
|
1
|
0
|
0
|
Baseline Characteristics
Evaluation of the Spectra Optia PMN Cell Collection Procedure
Baseline characteristics by cohort
| Measure |
Arm 1
n=17 Participants
In Arm 1 the first PMN cell collection was performed using the Spectra Optia System and the second PMN cell collection using the COBE Spectra System for each subject.
|
Arm 2
n=15 Participants
In Arm 2 the first PMN cell collection was performed using the COBE Spectra System and the second PMN cell collection using the Spectra Optia System for each subject.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.5 years
STANDARD_DEVIATION 10.99 • n=93 Participants
|
38.3 years
STANDARD_DEVIATION 13.69 • n=4 Participants
|
36.3 years
STANDARD_DEVIATION 12.27 • n=27 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
29 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
29 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: within 1 hour prior and within 5 minutes after each collection procedureThe 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.
Outcome measures
| Measure |
Arm 1 - Spectra Optia Followed by COBE Spectra
n=17 Participants
In Arm 1 the first PMN cell collection was performed using the Spectra Optia System and the second PMN cell collection using the COBE Spectra System for each subject.
|
Arm 2 - COBE Spectra Followed by Spectra Optia
n=15 Participants
In Arm 2 the first PMN cell collection was performed using the COBE Spectra System and the second PMN cell collection using the Spectra Optia System for each subject.
|
|---|---|---|
|
Granulocyte/PMN Cell Collection Efficiency
Spectra Optia CE%
|
54.7 percent cells processed
Standard Deviation 6.46
|
52.4 percent cells processed
Standard Deviation 7.43
|
|
Granulocyte/PMN Cell Collection Efficiency
COBE Spectra CE%
|
41.9 percent cells processed
Standard Deviation 6.14
|
44.7 percent cells processed
Standard Deviation 6.18
|
SECONDARY outcome
Timeframe: within 1 hour prior and within 5 minutes after each collection procedureComparison of collection efficiencies associated with the Granulocyte Cell Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems for white blood cells and platelets. CE is a measurement of device performance calculated using donor and blood product blood counts collected immediately before and after the collection procedure.
Outcome measures
| Measure |
Arm 1 - Spectra Optia Followed by COBE Spectra
n=17 Participants
In Arm 1 the first PMN cell collection was performed using the Spectra Optia System and the second PMN cell collection using the COBE Spectra System for each subject.
|
Arm 2 - COBE Spectra Followed by Spectra Optia
n=15 Participants
In Arm 2 the first PMN cell collection was performed using the COBE Spectra System and the second PMN cell collection using the Spectra Optia System for each subject.
|
|---|---|---|
|
Performance
Spectra Optia PLT CE%
|
11.2 percent of cells processed
Standard Deviation 1.59
|
10.4 percent of cells processed
Standard Deviation 1.19
|
|
Performance
Spectra Optia WBC CE%
|
56.6 percent of cells processed
Standard Deviation 6.15
|
55.4 percent of cells processed
Standard Deviation 6.67
|
|
Performance
COBE Spectra WBC CE%
|
44.0 percent of cells processed
Standard Deviation 0.06
|
46.9 percent of cells processed
Standard Deviation 5.96
|
|
Performance
COBE Spectra PLT CE%
|
11.7 percent of cells processed
Standard Deviation 3.09
|
9.7 percent of cells processed
Standard Deviation 2.07
|
SECONDARY outcome
Timeframe: within 5 minutes after each collection procedureCharacterization of the collected blood product, specifically total PMN cell yield. This is a measurement of device performance measured by calculating cell counts in samples from the collected blood product.
Outcome measures
| Measure |
Arm 1 - Spectra Optia Followed by COBE Spectra
n=17 Participants
In Arm 1 the first PMN cell collection was performed using the Spectra Optia System and the second PMN cell collection using the COBE Spectra System for each subject.
|
Arm 2 - COBE Spectra Followed by Spectra Optia
n=15 Participants
In Arm 2 the first PMN cell collection was performed using the COBE Spectra System and the second PMN cell collection using the Spectra Optia System for each subject.
|
|---|---|---|
|
Characterization of Blood Product - PMN Cell Yield
COBE Spectra PMN Cell Yield
|
1.1 cells *10^10
Standard Deviation 0.28
|
1.2 cells *10^10
Standard Deviation 0.25
|
|
Characterization of Blood Product - PMN Cell Yield
Spectra Optia PMN Cell Yield
|
1.4 cells *10^10
Standard Deviation 0.30
|
1.4 cells *10^10
Standard Deviation 0.34
|
SECONDARY outcome
Timeframe: within 5 minutes after each collection procedureCharacterization of the collected blood product, specifically PMN cell yield per liter blood processed. This is a measurement of device performance measured by calculating cell counts in samples from the collected blood product and blood processed measured by the device.
Outcome measures
| Measure |
Arm 1 - Spectra Optia Followed by COBE Spectra
n=17 Participants
In Arm 1 the first PMN cell collection was performed using the Spectra Optia System and the second PMN cell collection using the COBE Spectra System for each subject.
|
Arm 2 - COBE Spectra Followed by Spectra Optia
n=15 Participants
In Arm 2 the first PMN cell collection was performed using the COBE Spectra System and the second PMN cell collection using the Spectra Optia System for each subject.
|
|---|---|---|
|
Characterization of Blood Product - PMN Cell Yield Per Liter of Blood Processed
Spectra Optia PMN Cell Yield per L of Blood Proces
|
1.4 cells *10^10 per L of blood processed
Standard Deviation 0.30
|
1.4 cells *10^10 per L of blood processed
Standard Deviation 0.34
|
|
Characterization of Blood Product - PMN Cell Yield Per Liter of Blood Processed
COBE Spectra PMN Cell Yield per L of Blood Proc
|
1.1 cells *10^10 per L of blood processed
Standard Deviation 0.28
|
1.2 cells *10^10 per L of blood processed
Standard Deviation 0.25
|
SECONDARY outcome
Timeframe: within 5 minutes after collection procedureCharacterization of the collected blood product, specifically PMN cell viability measured by an assay preformed on the collected blood product.
Outcome measures
| Measure |
Arm 1 - Spectra Optia Followed by COBE Spectra
n=17 Participants
In Arm 1 the first PMN cell collection was performed using the Spectra Optia System and the second PMN cell collection using the COBE Spectra System for each subject.
|
Arm 2 - COBE Spectra Followed by Spectra Optia
n=15 Participants
In Arm 2 the first PMN cell collection was performed using the COBE Spectra System and the second PMN cell collection using the Spectra Optia System for each subject.
|
|---|---|---|
|
Characterization of the Blood Product - PMN Cell Viability
Spectra Optia PMN viability
|
99.6 percent of viable cells
Standard Deviation 0.22
|
99.6 percent of viable cells
Standard Deviation 0.28
|
|
Characterization of the Blood Product - PMN Cell Viability
COBE Spectra PMN viability
|
99.6 percent of viable cells
Standard Deviation 0.34
|
99.2 percent of viable cells
Standard Deviation 1.81
|
SECONDARY outcome
Timeframe: within 5 minutes after collection procedureCharacterization of the collected blood product, specifically red blood cell (RBC) contamination as measured by hematocrit in the collected PMN product.
Outcome measures
| Measure |
Arm 1 - Spectra Optia Followed by COBE Spectra
n=32 Participants
In Arm 1 the first PMN cell collection was performed using the Spectra Optia System and the second PMN cell collection using the COBE Spectra System for each subject.
|
Arm 2 - COBE Spectra Followed by Spectra Optia
In Arm 2 the first PMN cell collection was performed using the COBE Spectra System and the second PMN cell collection using the Spectra Optia System for each subject.
|
|---|---|---|
|
Characterization of the Blood Product - RBC Contamination
Spectra Optia Product HCT
|
7.4 RBC percent of product volume
Standard Deviation 2.62
|
—
|
|
Characterization of the Blood Product - RBC Contamination
COBE Spectra Product HCT
|
7.5 RBC percent of product volume
Standard Deviation 3.71
|
—
|
SECONDARY outcome
Timeframe: within 5 minutes after collection procedureCharacterization of the collected blood product, specifically product volume.
Outcome measures
| Measure |
Arm 1 - Spectra Optia Followed by COBE Spectra
n=17 Participants
In Arm 1 the first PMN cell collection was performed using the Spectra Optia System and the second PMN cell collection using the COBE Spectra System for each subject.
|
Arm 2 - COBE Spectra Followed by Spectra Optia
n=15 Participants
In Arm 2 the first PMN cell collection was performed using the COBE Spectra System and the second PMN cell collection using the Spectra Optia System for each subject.
|
|---|---|---|
|
Characterization of the Blood Product - Volume
Spectra Optia Product Volume
|
472.6 mL
Standard Deviation 1.77
|
471.9 mL
Standard Deviation 1.49
|
|
Characterization of the Blood Product - Volume
COBE Spectra Product Volume
|
329.7 mL
Standard Deviation 55.72
|
298.5 mL
Standard Deviation 53.04
|
SECONDARY outcome
Timeframe: Result captured immediately upon completion of procedureProcedure time for collections on the Spectra Optia vs. the COBE Spectra.
Outcome measures
| Measure |
Arm 1 - Spectra Optia Followed by COBE Spectra
n=17 Participants
In Arm 1 the first PMN cell collection was performed using the Spectra Optia System and the second PMN cell collection using the COBE Spectra System for each subject.
|
Arm 2 - COBE Spectra Followed by Spectra Optia
n=15 Participants
In Arm 2 the first PMN cell collection was performed using the COBE Spectra System and the second PMN cell collection using the Spectra Optia System for each subject.
|
|---|---|---|
|
Usability/Assessment of System Operation - Time
COBE Spectra Procedure Time
|
119.6 minutes
Standard Deviation 18.65
|
112.3 minutes
Standard Deviation 19.83
|
|
Usability/Assessment of System Operation - Time
Spectra Optia Procedure Time
|
136.8 minutes
Standard Deviation 20.78
|
120.3 minutes
Standard Deviation 17.58
|
SECONDARY outcome
Timeframe: Adjustments known immediately upon completion of the procedureNumber of operator adjustments aimed at establishing and maintaining the plasma/ cellular interface: namely, on Spectra Optia, the adjustment of collection preference and, on COBE Spectra, the adjustment of the plasma pump flow rate.
Outcome measures
| Measure |
Arm 1 - Spectra Optia Followed by COBE Spectra
n=17 Participants
In Arm 1 the first PMN cell collection was performed using the Spectra Optia System and the second PMN cell collection using the COBE Spectra System for each subject.
|
Arm 2 - COBE Spectra Followed by Spectra Optia
n=15 Participants
In Arm 2 the first PMN cell collection was performed using the COBE Spectra System and the second PMN cell collection using the Spectra Optia System for each subject.
|
|---|---|---|
|
Usability/Assessment of System Operation - Adjustments
COBE Spectra adjustments
|
9.3 number of adjustments
Standard Deviation 3.67
|
10.7 number of adjustments
Standard Deviation 4.68
|
|
Usability/Assessment of System Operation - Adjustments
Spectra Optia adjustments
|
4.6 number of adjustments
Standard Deviation 2.12
|
5.8 number of adjustments
Standard Deviation 2.48
|
SECONDARY outcome
Timeframe: Result know immediately upon successful completion of procedureOutcome measures
| Measure |
Arm 1 - Spectra Optia Followed by COBE Spectra
n=32 Participants
In Arm 1 the first PMN cell collection was performed using the Spectra Optia System and the second PMN cell collection using the COBE Spectra System for each subject.
|
Arm 2 - COBE Spectra Followed by Spectra Optia
In Arm 2 the first PMN cell collection was performed using the COBE Spectra System and the second PMN cell collection using the Spectra Optia System for each subject.
|
|---|---|---|
|
Usability/Assessment of System Operation - Device Malfunctions
Spectra Optia device deficiencies
|
5 events
|
—
|
|
Usability/Assessment of System Operation - Device Malfunctions
COBE Spectra device deficiencies
|
0 events
|
—
|
SECONDARY outcome
Timeframe: 48-hours after last procedure* Serious adverse events (SAEs) and unanticipated (serious) adverse device/procedure- related events (UADEs), adverse events (AEs). * any clinically significant changes to Complete Blood Count with differential white cell count (CBCD) and any significant changes to vital signs (temperature, heart rate, blood pressure) were captured as AEs. Also provided in full report to FDA.
Outcome measures
| Measure |
Arm 1 - Spectra Optia Followed by COBE Spectra
n=32 Participants
In Arm 1 the first PMN cell collection was performed using the Spectra Optia System and the second PMN cell collection using the COBE Spectra System for each subject.
|
Arm 2 - COBE Spectra Followed by Spectra Optia
In Arm 2 the first PMN cell collection was performed using the COBE Spectra System and the second PMN cell collection using the Spectra Optia System for each subject.
|
|---|---|---|
|
Safety
COBE Spectra SAEs
|
0 events
|
—
|
|
Safety
Spectra Optia SAEs
|
0 events
|
—
|
|
Safety
Spectra Optia UADEs
|
0 events
|
—
|
|
Safety
COBE Spectra UADEs
|
0 events
|
—
|
|
Safety
Number of subjects with >=1 AE
|
17 events
|
—
|
Adverse Events
Spectra Optia
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
COBE Spectra
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Spectra Optia
n=48 participants at risk
A total of n=48 subjects were either randomized to receive a procedure (n=42) or were assigned the Spectra Optia as a lead-in subject (lead-in n=6). Lead-in donors were not randomized and received the Spectra Optia only for training purposes and are included for Spectra Optia safety only. Randomized subjects are included in safety regardless if they withdrew or did not complete a procedure. Spectra Optia events are AEs during the study period when the subject received the Spectra Optia.
|
COBE Spectra
n=42 participants at risk
A total of n=42 subjects were randomized to receive a procedure. Randomized subjects are included in safety regardless if they withdrew or did not complete a procedure. Lead-in subjects are never exposed to COBE Spectra per protocol and not included. COBE Spectra events are AEs during the study period when the subject received the COBE Spectra.
|
|---|---|---|
|
Nervous system disorders
headache
|
18.8%
9/48 • Number of events 10 • Adverse events were collected from the point of randomization until 48-hours after the last study procedure.
|
14.3%
6/42 • Number of events 7 • Adverse events were collected from the point of randomization until 48-hours after the last study procedure.
|
|
Musculoskeletal and connective tissue disorders
back pain
|
8.3%
4/48 • Number of events 4 • Adverse events were collected from the point of randomization until 48-hours after the last study procedure.
|
7.1%
3/42 • Number of events 3 • Adverse events were collected from the point of randomization until 48-hours after the last study procedure.
|
|
Psychiatric disorders
insomnia
|
8.3%
4/48 • Number of events 4 • Adverse events were collected from the point of randomization until 48-hours after the last study procedure.
|
4.8%
2/42 • Number of events 2 • Adverse events were collected from the point of randomization until 48-hours after the last study procedure.
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
6.2%
3/48 • Number of events 3 • Adverse events were collected from the point of randomization until 48-hours after the last study procedure.
|
7.1%
3/42 • Number of events 3 • Adverse events were collected from the point of randomization until 48-hours after the last study procedure.
|
|
Vascular disorders
haematoma
|
8.3%
4/48 • Number of events 4 • Adverse events were collected from the point of randomization until 48-hours after the last study procedure.
|
0.00%
0/42 • Adverse events were collected from the point of randomization until 48-hours after the last study procedure.
|
|
Musculoskeletal and connective tissue disorders
sore shoulder
|
6.2%
3/48 • Number of events 3 • Adverse events were collected from the point of randomization until 48-hours after the last study procedure.
|
0.00%
0/42 • Adverse events were collected from the point of randomization until 48-hours after the last study procedure.
|
|
Nervous system disorders
tingling
|
2.1%
1/48 • Number of events 1 • Adverse events were collected from the point of randomization until 48-hours after the last study procedure.
|
4.8%
2/42 • Number of events 2 • Adverse events were collected from the point of randomization until 48-hours after the last study procedure.
|
Additional Information
Raymond P. Goodrich, PhD / VP, Scientific and Clinical Affairs; Chief Science Officer-BBT
Terumo BCT
Phone: 303.205.2680
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60