NCT01201291

Brief Summary

Aim of the study is to investigate the impact of two different fractions of inspired oxygen (FiO2) on outcome in patients with severe traumatic brain injury (TBI).

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
terminated

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

September 13, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 14, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2010

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

August 14, 2018

Status Verified

August 1, 2018

Enrollment Period

7.8 years

First QC Date

September 13, 2010

Last Update Submit

August 13, 2018

Conditions

Traumatic Brain Injury | Patient

Keywords

TBINormobaric hyperoxiaOutcomeGOSGOSE

Outcome Measures

Primary Outcomes (1)

  • Glasgow outcome scale(GOS) and/or Extended glasgow outcome scale (GOSE)

    The study is powered to have 80% power at 5% significance level to detect a treatment effect that decreases the proportion of poor outcome from 55% to 45%. Each patient is given an individualized tailored prognosis based on patient's baseline prognosis in a large reference population. Outcome is measured by using functional outcome score, Glasgow outcome score (GOS) and/or GOS extended (GOSE).

    6 months

Secondary Outcomes (1)

  • 6 month outcome

    6 months

Study Arms (2)

Fraction of inspired oxygen of 0.4

ACTIVE COMPARATOR

Fraction of inspired normobaric oxygen of 0.4 (low oxygen group)

Other: Normobaric oxygen

Fraction of inspired oxygen of 0.7

ACTIVE COMPARATOR

Fraction of inspired normobaric oxygen of 0.7 (high oxygen group)

Other: Normobaric oxygen

Interventions

Normobaric oxygenOTHER

Fraction of inspired oxygen

Fraction of inspired oxygen of 0.4Fraction of inspired oxygen of 0.7

Eligibility Criteria

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

You may qualify if:

  • Patients with isolated non-penetrating traumatic brain injury
  • Multiple trauma patient with brain injury and traumas outside abdomen, thorax or pelvis not affecting oxygenation
  • Glasgow coma scale eight or less (inclusive)
  • Expected need for intubation and for mechanical ventilation more than 24 hours.
  • Are recruited \<18 hours after admittance to ICU and
  • Time from TBI is less than 36 hours
  • Informed consent from patients representative

You may not qualify if:

  • Age \<18 or \>65 years,
  • Anticipated brain death in 12 hours (donor treatment) or otherwise moribund patient expected to die in 24 hours
  • Expected need for mechanical ventilation less than 24 hours
  • Insufficient oxygenation assessed by a clinician or multiple trauma patients with brain injury and severe abdominal, thoracic or pelvic injury possibly affecting oxygenation.
  • No consent
  • Insufficient oxygenation with the treatment modality of the lower oxygenation group (Pa02 less than 13 kPa or SpO2 95% with Fi02 40%, PEEP 10 or less) or oxygenation failure probable during ICU care (severe aspiration, multiple trauma patients with brain injury and severe abdominal, thoracic or pelvic injury possibly affecting oxygenation)
  • Penetrating TBI
  • No consent
  • Suspected pregnancy (perform urinary or serological pregnancy test if suspected)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Helsinki University Central Hospital, Töölö Hospital

Helsinki, Töölö, 00029, Finland

Location

Kuopio University Hospital

Kuopio, 70211, Finland

Location

Tampere University Hospital

Tampere, 33521, Finland

Location

Turku University Hospital

Turku, 20521, Finland

Location

Study Officials

  • Esko Ruokonen, Professor

    Kuopio University Hospital

    PRINCIPAL INVESTIGATOR

  • Stepani J Bendel, MD,PhD

    Kuopio University Hospital

    STUDY DIRECTOR

  • Maarit Lång, MD

    Kuopio University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 13, 2010

First Posted

September 14, 2010

Study Start

November 1, 2010

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

August 14, 2018

Record last verified: 2018-08

Locations

FI(4)