Safety and Tolerability of Oxycyte in Patients With Traumatic Brain Injury (TBI)
Status:
Terminated
Trial end date:
2014-09-01
Target enrollment:
Participant gender:
Summary
The primary objective of this study is to evaluate the safety and tolerability of a single
administration of Oxycyte in patients with severe non-penetrating traumatic brain injury
(TBI).
In the first dose level (Cohort 1), 11 patients were randomized 2:1 to receive either 1.0
mL/kg Oxycyte (0.6 g/kg; n=8) or NS (n=3). A total of 8 patients received Oxycyte. The Data
Safety Monitoring Board (DSMB) reviewed the safety data for patients in Cohort 1 through Day
14, and approved escalation to the next dose.
In Cohort 2, 18 patients will be randomized 2:1 to receive either 2.0 mL/kg Oxycyte (1.2
g/kg; n=12) or NS (n=6). The DSMB will then review the safety data for all patients in Cohort
2 through Day 14 and either approve escalation to the highest dose or remain at the current
dose. If remaining at the current dose level (Cohort 2) an additional 50 patients will be
randomized 1:1 to Oxycyte (n=25) or NS (n=25) and treated.
If escalation occurs to Cohort 3, 18 patients would be randomized 2:1 to Oxycyte (n=12) or NS
(n=6) to receive the 3.0 mL/kg dose. The DSMB would again review the safety data and decide
whether to treat an additional 50 patients at this dose or to decrease the dose back to 2.0
mL/kg. This group would be randomized 1:1 to receive Oxycyte (n=25) or NS.