Trial Outcomes & Findings for Evaluation of Whole Blood With CPD Anticoagulant and AS-7/SOLX Additive Solution (NCT NCT02145507)
NCT ID: NCT02145507
Last Updated: 2022-04-25
Results Overview
The percent of recovered red blood cells when the content of pre-filtration whole blood is compared to the post-filtration leukoreduced whole blood content.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
170 participants
Primary outcome timeframe
Arm and product dependent (< 8 hours, 20-24 hours, 66-72 hours post collection)
Results posted on
2022-04-25
Participant Flow
170 participants were enrolled. 82 participants were enrolled in Arm 1 and 88 participants were enrolled in Arm 2. In Arm 1, 70 participants successfully completed the first donation, and 63 completed the second donation. In Arm 2, 67 participants successfully completed the first donation, and 60 completed the second donation.
Participant milestones
| Measure |
Arm 1: Room Temperature
Whole blood donation for room temperature storage of IP and CP.
SOLX (Investigational Product): SOLX is regulated as a drug but is not intended to provide a direct therapeutic benefit.
AS-3 (Control): AS-3 solution is regulated as a drug but is not intended to provide a direct therapeutic benefit.
|
Arm 2: Cold Storage
Whole blood donation for cold storage for IP and CP.
SOLX (Investigational Product): SOLX is regulated as a drug but is not intended to provide a direct therapeutic benefit.
AS-3 (Control): AS-3 solution is regulated as a drug but is not intended to provide a direct therapeutic benefit.
|
|---|---|---|
|
First Donation
STARTED
|
82
|
88
|
|
First Donation
Randomized to Have Blood Processed With SOLX (IP)
|
52
|
51
|
|
First Donation
Randomized to Have Blood Processed With AS-3 (CP)
|
30
|
37
|
|
First Donation
COMPLETED
|
70
|
67
|
|
First Donation
NOT COMPLETED
|
12
|
21
|
|
Second Donation
STARTED
|
65
|
65
|
|
Second Donation
Blood Processed With AS-3 (CP)
|
39
|
35
|
|
Second Donation
Blood Processed With SOLX (IP)
|
26
|
27
|
|
Second Donation
COMPLETED
|
63
|
60
|
|
Second Donation
NOT COMPLETED
|
2
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Whole Blood With CPD Anticoagulant and AS-7/SOLX Additive Solution
Baseline characteristics by cohort
| Measure |
Arm 1: Room Temperature Storage/Filtration
n=82 Participants
In vitro whole blood storage, leukoreduction and processing of donated whole blood.
SOLX: SOLX is regulated as a drug but is not intended to provide a direct therapeutic benefit.
|
Arm 2 : Cold Storage/Filtration
n=88 Participants
In vitro analysis of whole blood following refrigerated storage for \> 66 hours prior to leukoreduction and subsequent processing of packed red blood cells.
SOLX: SOLX is regulated as a drug but is not intended to provide a direct therapeutic benefit.
|
Total
n=170 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.4 years
STANDARD_DEVIATION 13.05 • n=99 Participants
|
38.7 years
STANDARD_DEVIATION 14.24 • n=107 Participants
|
41.1 years
STANDARD_DEVIATION 13.98 • n=206 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=99 Participants
|
46 Participants
n=107 Participants
|
91 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
79 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
81 Participants
n=99 Participants
|
83 Participants
n=107 Participants
|
164 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
69 Participants
n=99 Participants
|
70 Participants
n=107 Participants
|
139 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
82 participants
n=99 Participants
|
88 participants
n=107 Participants
|
170 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Arm and product dependent (< 8 hours, 20-24 hours, 66-72 hours post collection)Population: Population represents matched samples from the same donor (i.e., each donor's blood was collected with the SOLX set and the Control set, and as such, Arm 1 represents 60 donors and Arm 2 represents 58 donors).
The percent of recovered red blood cells when the content of pre-filtration whole blood is compared to the post-filtration leukoreduced whole blood content.
Outcome measures
| Measure |
Arm 1: SOLX Room Temperature Storage/Filtration
n=60 Participants
SOLX (Investigational Product)
SOLX (Investigational): SOLX is regulated as a drug but is not intended to provide a direct therapeutic benefit.
AS-3 (Control): AS-3 solution is regulated as a drug but is not intended to provide a direct therapeutic benefit
|
Arm 2 : SOLX Cold Storage
n=58 Participants
SOLX (Investigational Product)
SOLX (Investigational): SOLX is regulated as a drug but is not intended to provide a direct therapeutic benefit.
|
Arm 1: Control Room Temperature Storage/Filtration
n=60 Participants
AS-3 (Control)
AS-3 (Control): AS-3 solution is regulated as a drug but is not intended to provide a direct therapeutic benefit
|
Arm 2: Control Cold Storage
n=58 Participants
AS-3 (Control)
AS-3 (Control): AS-3 solution is regulated as a drug but is not intended to provide a direct therapeutic benefit
|
|---|---|---|---|---|
|
Red Blood Cell Post-filtration Recovery
|
92.57 % recovery at day 0
Standard Deviation 1.76
|
92.70 % recovery at day 0
Standard Deviation 2.34
|
90.96 % recovery at day 0
Standard Deviation 2.18
|
90.23 % recovery at day 0
Standard Deviation 3.46
|
PRIMARY outcome
Timeframe: <8 hours and 20-24 hoursPopulation: Evaluable population
The level of residual white blood cells in whole blood filtered after either \<8 hours (AS-3) or 20-24hours (SOLX) of room temperature storage or cold storage for 72 hours.
Outcome measures
| Measure |
Arm 1: SOLX Room Temperature Storage/Filtration
n=67 Participants
SOLX (Investigational Product)
SOLX (Investigational): SOLX is regulated as a drug but is not intended to provide a direct therapeutic benefit.
AS-3 (Control): AS-3 solution is regulated as a drug but is not intended to provide a direct therapeutic benefit
|
Arm 2 : SOLX Cold Storage
n=61 Participants
SOLX (Investigational Product)
SOLX (Investigational): SOLX is regulated as a drug but is not intended to provide a direct therapeutic benefit.
|
Arm 1: Control Room Temperature Storage/Filtration
n=64 Participants
AS-3 (Control)
AS-3 (Control): AS-3 solution is regulated as a drug but is not intended to provide a direct therapeutic benefit
|
Arm 2: Control Cold Storage
n=64 Participants
AS-3 (Control)
AS-3 (Control): AS-3 solution is regulated as a drug but is not intended to provide a direct therapeutic benefit
|
|---|---|---|---|---|
|
Residual Leukocyte Count
|
2.53 rWBC count (# rWBC x 10^5/unit)
Standard Deviation 2.20
|
1.25 rWBC count (# rWBC x 10^5/unit)
Standard Deviation 3.78
|
1.00 rWBC count (# rWBC x 10^5/unit)
Standard Deviation 0.45
|
0.84 rWBC count (# rWBC x 10^5/unit)
Standard Deviation 0.50
|
Adverse Events
Arm 1: SOLX Room Temperature Storage/Filtration
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Arm 2 : SOLX Cold Storage
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Arm 1: Control Room Temperature Storage/Filtration
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Arm 2: Control Cold Storage
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm 1: SOLX Room Temperature Storage/Filtration
n=82 participants at risk
SOLX (Investigational Product)
SOLX (Investigational): SOLX is regulated as a drug but is not intended to provide a direct therapeutic benefit.
|
Arm 2 : SOLX Cold Storage
n=88 participants at risk
SOLX (Investigational Product)
SOLX (Investigational): SOLX is regulated as a drug but is not intended to provide a direct therapeutic benefit.
|
Arm 1: Control Room Temperature Storage/Filtration
n=82 participants at risk
AS-3 (Control)
AS-3 (Control): AS-3 solution is regulated as a drug but is not intended to provide a direct therapeutic benefit
|
Arm 2: Control Cold Storage
n=88 participants at risk
AS-3 (Control)
AS-3 (Control): AS-3 solution is regulated as a drug but is not intended to provide a direct therapeutic benefit
|
|---|---|---|---|---|
|
Psychiatric disorders
Vasvagal reaction to blood donation (vascular access)
|
1.2%
1/82 • Number of events 1 • Events self-reported by the study donors were recorded within 24 hours of the completion of blood donation
The investigational product (SOLX) does not come in contact with the blood donors. Therefore, all adverse events are related to standard blood donation only.
|
4.5%
4/88 • Number of events 4 • Events self-reported by the study donors were recorded within 24 hours of the completion of blood donation
The investigational product (SOLX) does not come in contact with the blood donors. Therefore, all adverse events are related to standard blood donation only.
|
1.2%
1/82 • Number of events 1 • Events self-reported by the study donors were recorded within 24 hours of the completion of blood donation
The investigational product (SOLX) does not come in contact with the blood donors. Therefore, all adverse events are related to standard blood donation only.
|
1.1%
1/88 • Number of events 1 • Events self-reported by the study donors were recorded within 24 hours of the completion of blood donation
The investigational product (SOLX) does not come in contact with the blood donors. Therefore, all adverse events are related to standard blood donation only.
|
|
Blood and lymphatic system disorders
Hematoma
|
0.00%
0/82 • Events self-reported by the study donors were recorded within 24 hours of the completion of blood donation
The investigational product (SOLX) does not come in contact with the blood donors. Therefore, all adverse events are related to standard blood donation only.
|
0.00%
0/88 • Events self-reported by the study donors were recorded within 24 hours of the completion of blood donation
The investigational product (SOLX) does not come in contact with the blood donors. Therefore, all adverse events are related to standard blood donation only.
|
2.4%
2/82 • Number of events 2 • Events self-reported by the study donors were recorded within 24 hours of the completion of blood donation
The investigational product (SOLX) does not come in contact with the blood donors. Therefore, all adverse events are related to standard blood donation only.
|
0.00%
0/88 • Events self-reported by the study donors were recorded within 24 hours of the completion of blood donation
The investigational product (SOLX) does not come in contact with the blood donors. Therefore, all adverse events are related to standard blood donation only.
|
Additional Information
Adrian Orr, Clinical Research Director
Haemonetics (trial sponsor)
Phone: 781.356.9647
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60