NCT00879892

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2009

Longer than P75 for phase_2

Geographic Reach
2 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 10, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 13, 2009

Completed
18 days until next milestone

Study Start

First participant enrolled

May 1, 2009

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

January 19, 2015

Status Verified

January 1, 2015

Enrollment Period

5.3 years

First QC Date

April 10, 2009

Last Update Submit

January 16, 2015

Conditions

Ischemic Brain Injury

Keywords

xenonhypothermiaout-of-hospital cardiac arrest

Outcome Measures

Primary Outcomes (1)

  • Primary outcome is to show a significant reduction in the degree of severity of the ischemic brain injury in the hypothermia+Xenon group as compared with the hypothermia group, reflected by various MRI techniques

    Power analysis was done with fractional anisotropy of diffusion tensor MRI

    within 24 hours after treatment and 10 +/-2 days after cardiac arrest

Secondary Outcomes (5)

  • Neurological outcome

    6 months after cardiac arrest

  • A transthoracic echocardiography will be performed for all feasible patients to investigate cardiac safety of the treatments

    Before, during and after treatments

  • Mortality

    6 months

  • Complication rate

    7 days

  • Morbidity

    6 months

Study Arms (2)

Hypothermia and xenon

ACTIVE COMPARATOR
Drug: xenonOther: Hypothermia

Hypothermia

ACTIVE COMPARATOR
Other: Hypothermia

Interventions

xenonDRUG

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

Hypothermia and xenon
HypothermiaOTHER

24 hour, target core temperature 33

HypothermiaHypothermia and xenon

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ventricular fibrillation or non-perfusive ventricular tachycardia as initial cardiac rhythm
  • The 1st attempt at resuscitation by emergency medical personnel must appear within 15 minutes after the collapse
  • The cause for collapse should be considered primary as cardiogenic and the return of spontaneous circulation (ROSC) should have been gained in 45 minutes after the collapse
  • Patient should be still unconscious in the emergency room
  • Age: 18 - 80 years
  • Obtained consent within 4 hours after arrival to the hospital

You may not qualify if:

  • Hypothermia (\< 30°C core temperature)
  • Unconsciousness before cardiac arrest (cerebral trauma, spontaneous cerebral hemorrhages, intoxications etc.)
  • Response to verbal commands after the return of spontaneous circulation and before randomization
  • Pregnancy
  • Coagulopathy
  • Terminal phase of a chronic disease
  • Systolic arterial pressure \< 80 mmHg or mean arterial pressure \< 60 mmHg for over 30 min period after ROSC
  • Evidence of hypoxemia (arterial oxygen saturation \< 85%) for \> 15 minutes after ROSC and before randomization.
  • Factors making participation in follow-up unlikely
  • Enrolment in another study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Department of Anesthesia and Perioperative Care

San Francisco, California, United States

Location

Department of Neurology, Meilahti, Helsinki University Hospital

Helsinki, 340, Finland

Location

Department of Radiology, HUSRontgen, Meilahti, Helsinki University Hospital

Helsinki, 340, Finland

Location

Intensive Care Unit, Meilahti, Helsinki University Hospital

Helsinki, 340, Finland

Location

Department of Cardiology, Meilahti, Helsinki University Hospital

Helsinki, 800, Finland

Location

Adult Intensive Care Unit, Turku University Hospital

Turku, 20521, Finland

Location

Department of Internal Medicine, Division of Cardiology, Turku University Hospital

Turku, 20521, Finland

Location

Department of Neurology; Turku University Hospital

Turku, 20521, Finland

Location

Department of Radiology, Turku University Hospital

Turku, 20521, Finland

Location

PET Centre

Turku, 20521, Finland

Location

Related Publications (7)

  • Hypothermia after Cardiac Arrest Study Group. Mild therapeutic hypothermia to improve the neurologic outcome after cardiac arrest. N Engl J Med. 2002 Feb 21;346(8):549-56. doi: 10.1056/NEJMoa012689.

    PMID: 11856793BACKGROUND

  • Hollmen CC, Vorobyev V, Parkkola R, Posti JP, Saunavaara J, Laitio R, Arola O, Hynninen M, Backlund M, Blennow K, Zetterberg H, Martola J, Ylikoski E, Roine RO, Tiainen M, Scheinin H, Maze M, Vahlberg T, Laitio TT; Xe-HYPOTHECA Consortium. Grey matter volume reduction and its association with brain-enriched blood biomarkers in out-of-hospital cardiac arrest survivors. Sci Rep. 2025 Nov 26;15(1):42219. doi: 10.1038/s41598-025-26322-4.

    PMID: 41298726DERIVED

  • Hollmen C, Parkkola R, Vorobyev V, Saunavaara J, Laitio R, Arola O, Hynninen M, Backlund M, Martola J, Ylikoski E, Roine RO, Tiainen M, Scheinin H, Maze M, Vahlberg T, Laitio TT. Neuroprotective Effects of Inhaled Xenon Gas on Brain Structural Gray Matter Changes After Out-of-Hospital Cardiac Arrest Evaluated by Morphometric Analysis: A Substudy of the Randomized Xe-Hypotheca Trial. Neurocrit Care. 2025 Feb;42(1):131-141. doi: 10.1007/s12028-024-02053-8. Epub 2024 Jul 9.

    PMID: 38982000DERIVED

  • Nummela AJ, Scheinin H, Perola M, Joensuu A, Laitio R, Arola O, Gronlund J, Roine RO, Backlund M, Vahlberg TJ, Laitio T; Xe-Hypotheca Collaboration Group. A metabolic profile of xenon and metabolite associations with 6-month mortality after out-of-hospital cardiac arrest: A post-hoc study of the randomised Xe-Hypotheca trial. PLoS One. 2024 Jun 4;19(6):e0304966. doi: 10.1371/journal.pone.0304966. eCollection 2024.

    PMID: 38833442DERIVED

  • Koskensalo K, Virtanen S, Saunavaara J, Parkkola R, Laitio R, Arola O, Hynninen M, Silvasti P, Nukarinen E, Martola J, Silvennoinen HM, Tiainen M, Roine RO, Scheinin H, Saraste A, Maze M, Vahlberg T, Laitio TT; XeHYPOTHECA Research Group. Comparison of the prognostic value of early-phase proton magnetic resonance spectroscopy and diffusion tensor imaging with serum neuron-specific enolase at 72 h in comatose survivors of out-of-hospital cardiac arrest-a substudy of the XeHypotheca trial. Neuroradiology. 2023 Feb;65(2):349-360. doi: 10.1007/s00234-022-03063-z. Epub 2022 Oct 17.

    PMID: 36251060DERIVED

  • Laitio R, Hynninen M, Arola O, Virtanen S, Parkkola R, Saunavaara J, Roine RO, Gronlund J, Ylikoski E, Wennervirta J, Backlund M, Silvasti P, Nukarinen E, Tiainen M, Saraste A, Pietila M, Airaksinen J, Valanne L, Martola J, Silvennoinen H, Scheinin H, Harjola VP, Niiranen J, Korpi K, Varpula M, Inkinen O, Olkkola KT, Maze M, Vahlberg T, Laitio T. Effect of Inhaled Xenon on Cerebral White Matter Damage in Comatose Survivors of Out-of-Hospital Cardiac Arrest: A Randomized Clinical Trial. JAMA. 2016 Mar 15;315(11):1120-8. doi: 10.1001/jama.2016.1933.

    PMID: 26978207DERIVED

  • Arola OJ, Laitio RM, Roine RO, Gronlund J, Saraste A, Pietila M, Airaksinen J, Perttila J, Scheinin H, Olkkola KT, Maze M, Laitio TT. Feasibility and cardiac safety of inhaled xenon in combination with therapeutic hypothermia following out-of-hospital cardiac arrest. Crit Care Med. 2013 Sep;41(9):2116-24. doi: 10.1097/CCM.0b013e31828a4337.

    PMID: 23896830DERIVED

MeSH Terms

Conditions

HypothermiaOut-of-Hospital Cardiac Arrest

Interventions

Xenon

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsHeart ArrestHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Noble GasesElementsInorganic ChemicalsGases

Study Officials

  • Timo T Laitio, MD, PhD

    Department of Anaesthesiology, Intensive Care, Emergency Care and Pain Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator, study group leader

Study Record Dates

First Submitted

April 10, 2009

First Posted

April 13, 2009

Study Start

May 1, 2009

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

January 19, 2015

Record last verified: 2015-01

Locations

US(1)FI(9)