Trial Outcomes & Findings for Study of Oxycyte in Severe Closed Head Injury (NCT NCT00174980)

Last Updated: 2026-02-24

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

9 participants

Primary outcome timeframe

40 hours

Results posted on

2026-02-24

Participant milestones
Measure	Oxycyte, Perfluorocarbon one time dose of 3mL/kg over 15 minutes Oxycyte: intravenous infusion
Overall Study STARTED	9
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	2

Reasons for withdrawal
Measure	Oxycyte, Perfluorocarbon one time dose of 3mL/kg over 15 minutes Oxycyte: intravenous infusion
Overall Study Death	2

Study of Oxycyte in Severe Closed Head Injury

Baseline characteristics by cohort
Measure	Oxycyte, Perfluorocarbon n=9 Participants one time dose of 3mL/kg over 15 minutes Oxycyte: intravenous infusion
Age, Continuous	33.3 years STANDARD_DEVIATION 16.0 • n=58 Participants
Sex: Female, Male Female	2 Participants n=58 Participants
Sex: Female, Male Male	7 Participants n=58 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=58 Participants
Race (NIH/OMB) Asian	0 Participants n=58 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=58 Participants
Race (NIH/OMB) Black or African American	1 Participants n=58 Participants
Race (NIH/OMB) White	8 Participants n=58 Participants
Race (NIH/OMB) More than one race	0 Participants n=58 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=58 Participants
Region of Enrollment United States	9 Participants n=58 Participants

Timeframe: 40 hours

Outcome measures
Measure	Oxycyte, Perfluorocarbon n=9 Participants one time dose of 3mL/kg over 15 minutes Oxycyte: intravenous infusion
Brain Dialysate Concentration Data brain dialysate glucose concentration	800 microM/L Standard Deviation 518
Brain Dialysate Concentration Data brain dialysate lactate concentration	1066 microM/L Standard Deviation 299
Brain Dialysate Concentration Data brain dialysate glutmate concentration	13.48 microM/L Standard Deviation 10.8
Brain Dialysate Concentration Data brain dialysate pyruvate concentration	30.54 microM/L Standard Deviation 18.25

Serious events: 2 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events
Measure	Oxycyte, Perfluorocarbon n=9 participants at risk one time dose of 3mL/kg over 15 minutes Oxycyte: intravenous infusion
Injury, poisoning and procedural complications Injury, poisoning and procedural compliactions	11.1% 1/9 • Number of events 1 • 30 days
Cardiac disorders Cardiac disorders	11.1% 1/9 • Number of events 1 • 30 days

Other adverse events
Measure	Oxycyte, Perfluorocarbon n=9 participants at risk one time dose of 3mL/kg over 15 minutes Oxycyte: intravenous infusion
Respiratory, thoracic and mediastinal disorders infection	66.7% 6/9 • Number of events 6 • 30 days
Renal and urinary disorders infection	22.2% 2/9 • Number of events 2 • 30 days
Blood and lymphatic system disorders thrombocytopenia	44.4% 4/9 • Number of events 4 • 30 days
Hepatobiliary disorders elevated liver function tests	77.8% 7/9 • Number of events 7 • 30 days
Blood and lymphatic system disorders anemia	44.4% 4/9 • Number of events 4 • 30 days
Blood and lymphatic system disorders hemoglobin low	44.4% 4/9 • Number of events 4 • 30 days

Tenax Therapeutics, Inc

Phone: 919-855-2110