Trial intelligence / Profile preview

Oxycyte in severe non-penetrating traumatic brain injury

NCT00908063Phase 2

Key facts

Status
Terminated
Start
Oct 2009
Primary completion
Sep 2014
Countries
2
Modality
Nanoparticles, Small Molecules
Conditions
traumatic brain injury (TBI)
01

Overview

Phase 2, randomised, double-blind trial of perfluoro-tert-butylcyclohexane in traumatic brain injury (TBI) (2 arms), sponsored by Tenax Therapeutics. Primary endpoint: Safety and tolerability at Day 30. Started Oct 2009; status: terminated.

02

Design

2 arms
Study design
RandomizedDouble-blind
  • Oxycyte

    Single intravenous infusion of Oxycyte (1.0, 2.0, or 3.0 mL/kg)

  • Normal Saline

    Single intravenous infusion of Normal Saline

03

Who it enrols

Adult patients with severe non-penetrating TBI (GCS 4-8) able to be treated within 12 hours.

04

Endpoints

Primary

  • Safety and tolerability

Secondary

  • Efficacy as determined by short-term improvement

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