CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 110 enrolled
Drug / intervention
xenon +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00879892
NCT00879892Phase 2Completed
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Phase 2 Study of Effect of Xenon, in Combination With Therapeutic Hypothermia, on the Brain and on Neurological Outcome Following Brain Ischemia in Cardiac Arrest Patients

Turku University Hospital·interventional·Posted Apr 13, 2009·Updated Jan 19, 2015

In Brief

A Phase 2 clinical trial evaluating xenon and Hypothermia for Ischemic Brain Injury. Completed, enrolled 110 participants across 10 sites in 2 countries.

Detailed Summary

The main purpose of this study is to explore whether xenon is neuroprotective in humans. In addition, the purpose is to explore the underlying mechanisms for the possible synergistic neuroprotective interaction of xenon and hypothermia in patients suffering cerebral ischemia post cardiac arrest, by undertaking brain imaging to evaluate their effects on cerebral hypoxia, neuronal loss and mitochondrial dysfunction. In addition, the investigators aim to correlate these findings with neurological outcome to determine surrogate markers of favourable clinical outcome at six months.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIschemic Brain Injury
CountriesFinland, United States
CollaboratorsAcademy of Finland, University of Turku

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 13, 2009
Enrollment StartMay 1, 2009
Primary CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 17.2 years ago

Interventions

xenondrug

Gas, 24 hour inhalation, en tidal target concentration 40%

Hypothermiaother

24 hour, target core temperature 33