Trial Outcomes & Findings for Clinical Investigation to Evaluate the Hemanext® Oxygen Reduction System - Pivotal Trial (NCT NCT03301779)

NCT ID: NCT03301779

Last Updated: 2020-06-23

Results Overview

Percentage of packed Red Blood Cell units with hemolysis at day 42 of storage.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 100 participants
• Primary outcome timeframe: On day 42 of storage
• Results posted on: 2020-06-23

Participant Flow

Participants were immediately assigned to a group upon enrollment.

Participant milestones

Measure	Investigational Product First, Then Control Product A donor randomized to this arm donated their first whole blood unit to be stored with the Investigational Product.These units were processed in the Hemanext Oxygen Reduction Bag for 3 hours and then transferred to the Hemanext Storage Bag and stored for 42 days at 1-6°C. These donors then donated their second whole blood unit to be stored with the Control Product. These units were stored in a Haemonetics Leukotrap Whole Blood System for 42 days at 1-6°C.	Control Product First, Then Investigational Product A donor randomized to this arm donated their first whole blood unit to be stored with the Control Product. These units were stored in a Haemonetics Leukotrap Whole Blood System for 42 days at 1-6°C. These donors then donated their second whole blood unit to be stored with the Investigational Product.These units were processed in the Hemanext Oxygen Reduction Bag for 3 hours and then transferred to the Hemanext Storage Bag and stored for 42 days at 1-6°C.
Overall Study STARTED	48	52
Overall Study COMPLETED	40	45
Overall Study NOT COMPLETED	8	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Investigation to Evaluate the Hemanext® Oxygen Reduction System - Pivotal Trial

Baseline characteristics by cohort

Measure	All Study Donors n=100 Participants This study was a crossover design and all Donors donated units to both the Investigation and Control arms so the Baseline Measures for all donors are combined here irrespective of their randomization.
Age, Continuous	47.0 years STANDARD_DEVIATION 15.0 • n=5 Participants
Sex: Female, Male Female	47 Participants n=5 Participants
Sex: Female, Male Male	53 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	98 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	10 Participants n=5 Participants
Race (NIH/OMB) White	88 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: On day 42 of storage

Percentage of packed Red Blood Cell units with hemolysis at day 42 of storage.

Outcome measures

Measure	Investigational Product n=95 Participants Blood products from these donors will be processed and stored using the Hemanext Red Blood Cell Processing System. Hemanext Red Blood Cell Processing System: Leukoreduced red blood cell product from donors in the Investigational Product arm will be processed in the Hemanext Oxygen Reduction Bag for 3 hours and then transferred to the Hemanext Storage Bag and stored for 42 days at 1-6°C.	Control Product n=94 Participants Blood products from these donors will be stored in a Haemonetics Leukotrap Whole Blood System.
% of Red Blood Cells With Hemolysis	0.29 % of Red Blood Cells with Hemolysis Standard Deviation 0.168	0.29 % of Red Blood Cells with Hemolysis Standard Deviation 0.152

PRIMARY outcome

Timeframe: Day 42 of storage

The mean 24-hour, post-transfusion, in vivo red blood cell recovery.

Outcome measures

Measure	Investigational Product n=19 Participants Blood products from these donors will be processed and stored using the Hemanext Red Blood Cell Processing System. Hemanext Red Blood Cell Processing System: Leukoreduced red blood cell product from donors in the Investigational Product arm will be processed in the Hemanext Oxygen Reduction Bag for 3 hours and then transferred to the Hemanext Storage Bag and stored for 42 days at 1-6°C.	Control Product n=21 Participants Blood products from these donors will be stored in a Haemonetics Leukotrap Whole Blood System.
Dual Label 24 Hour In Vivo % Recovery of Red Blood Cells	89.3 % Recovery of Red Blood Cells Standard Deviation 5.81	85.8 % Recovery of Red Blood Cells Standard Deviation 6.12

PRIMARY outcome

Timeframe: Post-Filtration on Day 0

Percentage of red blood cells recovered after the filtration process.

Outcome measures

Measure	Investigational Product n=98 Participants Blood products from these donors will be processed and stored using the Hemanext Red Blood Cell Processing System. Hemanext Red Blood Cell Processing System: Leukoreduced red blood cell product from donors in the Investigational Product arm will be processed in the Hemanext Oxygen Reduction Bag for 3 hours and then transferred to the Hemanext Storage Bag and stored for 42 days at 1-6°C.	Control Product n=96 Participants Blood products from these donors will be stored in a Haemonetics Leukotrap Whole Blood System.
% Red Blood Cells Recovered Post-Filtration	92.3 % of Red Blood Cells Recovered Standard Deviation 1.9	91.1 % of Red Blood Cells Recovered Standard Deviation 4.31

Adverse Events

Investigational Product

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

Control Product

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Measure	Investigational Product n=100 participants at risk Blood products from these donors will be processed and stored using the Hemanext Red Blood Cell Processing System. Hemanext Red Blood Cell Processing System: Leukoreduced red blood cell product from donors in the Investigational Product arm will be processed in the Hemanext Oxygen Reduction Bag for 3 hours and then transferred to the Hemanext Storage Bag and stored for 42 days at 1-6°C.	Control Product n=100 participants at risk Blood products from these donors will be stored in a Haemonetics Leukotrap Whole Blood System.
Infections and infestations Appendicits	1.0% 1/100 • Number of events 1 • Study-related adverse events are defined as those study participant-reported adverse events occurring within 24-hours of donation and/or transfusion. Non-study-related adverse events outside of these periods were not recorded unless they were of a nature to impact study participant evaluability, safety or data validity.	1.0% 1/100 • Number of events 1 • Study-related adverse events are defined as those study participant-reported adverse events occurring within 24-hours of donation and/or transfusion. Non-study-related adverse events outside of these periods were not recorded unless they were of a nature to impact study participant evaluability, safety or data validity.

Other adverse events

Measure	Investigational Product n=100 participants at risk Blood products from these donors will be processed and stored using the Hemanext Red Blood Cell Processing System. Hemanext Red Blood Cell Processing System: Leukoreduced red blood cell product from donors in the Investigational Product arm will be processed in the Hemanext Oxygen Reduction Bag for 3 hours and then transferred to the Hemanext Storage Bag and stored for 42 days at 1-6°C.	Control Product n=100 participants at risk Blood products from these donors will be stored in a Haemonetics Leukotrap Whole Blood System.
Injury, poisoning and procedural complications Subject called to say he had dizziness at work after donation.	1.0% 1/100 • Number of events 1 • Study-related adverse events are defined as those study participant-reported adverse events occurring within 24-hours of donation and/or transfusion. Non-study-related adverse events outside of these periods were not recorded unless they were of a nature to impact study participant evaluability, safety or data validity.	1.0% 1/100 • Number of events 1 • Study-related adverse events are defined as those study participant-reported adverse events occurring within 24-hours of donation and/or transfusion. Non-study-related adverse events outside of these periods were not recorded unless they were of a nature to impact study participant evaluability, safety or data validity.
Injury, poisoning and procedural complications Dizzyness after donation	1.0% 1/100 • Number of events 1 • Study-related adverse events are defined as those study participant-reported adverse events occurring within 24-hours of donation and/or transfusion. Non-study-related adverse events outside of these periods were not recorded unless they were of a nature to impact study participant evaluability, safety or data validity.	1.0% 1/100 • Number of events 1 • Study-related adverse events are defined as those study participant-reported adverse events occurring within 24-hours of donation and/or transfusion. Non-study-related adverse events outside of these periods were not recorded unless they were of a nature to impact study participant evaluability, safety or data validity.
Injury, poisoning and procedural complications Light-headedness after donation	4.0% 4/100 • Number of events 4 • Study-related adverse events are defined as those study participant-reported adverse events occurring within 24-hours of donation and/or transfusion. Non-study-related adverse events outside of these periods were not recorded unless they were of a nature to impact study participant evaluability, safety or data validity.	4.0% 4/100 • Number of events 4 • Study-related adverse events are defined as those study participant-reported adverse events occurring within 24-hours of donation and/or transfusion. Non-study-related adverse events outside of these periods were not recorded unless they were of a nature to impact study participant evaluability, safety or data validity.
Injury, poisoning and procedural complications Bruising or pain on arm at blood donation site	4.0% 4/100 • Number of events 4 • Study-related adverse events are defined as those study participant-reported adverse events occurring within 24-hours of donation and/or transfusion. Non-study-related adverse events outside of these periods were not recorded unless they were of a nature to impact study participant evaluability, safety or data validity.	4.0% 4/100 • Number of events 4 • Study-related adverse events are defined as those study participant-reported adverse events occurring within 24-hours of donation and/or transfusion. Non-study-related adverse events outside of these periods were not recorded unless they were of a nature to impact study participant evaluability, safety or data validity.
Injury, poisoning and procedural complications Nausea after donation	1.0% 1/100 • Number of events 1 • Study-related adverse events are defined as those study participant-reported adverse events occurring within 24-hours of donation and/or transfusion. Non-study-related adverse events outside of these periods were not recorded unless they were of a nature to impact study participant evaluability, safety or data validity.	1.0% 1/100 • Number of events 1 • Study-related adverse events are defined as those study participant-reported adverse events occurring within 24-hours of donation and/or transfusion. Non-study-related adverse events outside of these periods were not recorded unless they were of a nature to impact study participant evaluability, safety or data validity.
Cardiac disorders Cardiac Ablation	1.0% 1/100 • Number of events 1 • Study-related adverse events are defined as those study participant-reported adverse events occurring within 24-hours of donation and/or transfusion. Non-study-related adverse events outside of these periods were not recorded unless they were of a nature to impact study participant evaluability, safety or data validity.	1.0% 1/100 • Number of events 1 • Study-related adverse events are defined as those study participant-reported adverse events occurring within 24-hours of donation and/or transfusion. Non-study-related adverse events outside of these periods were not recorded unless they were of a nature to impact study participant evaluability, safety or data validity.
Infections and infestations Side Pain	1.0% 1/100 • Number of events 1 • Study-related adverse events are defined as those study participant-reported adverse events occurring within 24-hours of donation and/or transfusion. Non-study-related adverse events outside of these periods were not recorded unless they were of a nature to impact study participant evaluability, safety or data validity.	1.0% 1/100 • Number of events 1 • Study-related adverse events are defined as those study participant-reported adverse events occurring within 24-hours of donation and/or transfusion. Non-study-related adverse events outside of these periods were not recorded unless they were of a nature to impact study participant evaluability, safety or data validity.

Additional Information

William Iselin

Hemanext

Phone: 7813017446

Email: william.iselin@hemanext.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place