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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01940861
Other study ID # Co-TBI
Secondary ID 2010/824
Status Recruiting
Phase N/A
First received September 9, 2013
Last updated November 21, 2014
Start date November 2014
Est. completion date December 2016

Study information

Verified date November 2014
Source Oslo University Hospital
Contact n/a
Is FDA regulated No
Health authority Norway: Ministry of Health and Care ServicesNorway: Regional Ethics Commitee
Study type Observational [Patient Registry]

Clinical Trial Summary

Vasopressor for current treatment protocols for acute traumatic brain injury can lead to vasoconstriction and thus cerebral hypoperfusion that can be detected with cerebral oxymetry as a drop in SCO2.


Recruitment information / eligibility

Status Recruiting
Enrollment 15
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- Patients with acute traumatic severe brain injury requiring neuro intensive care.

- The patient admitted must be at least 18 years of age and under 60 years.

- Intoxication is not an obstacle for inclusion as we believe this will not affect the recording in relation to our problem.

Exclusion Criteria:

- Traumatic injury in the frontal lobes corresponding to the area where ScO2 monitored.

- Patients in pharmacological studies.

- Patients with severe heart / lung / blood vessel diseases.

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Norway Oslo University Hospital Oslo

Sponsors (1)

Lead Sponsor Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Dosage of vasopressor 24 hours No
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