NCT01427959

Brief Summary

Tampere Traumatic head and brain injury study is a prospective study aiming to explore neuroradiological, neuropsychological, neurological and biochemical aspects of mild traumatic brain injury (mtbi). The main interest is on factors that effect to the outcome after mtbi. The study is conducted in Tampere University Hospital's emergency department between the 1st of August 2010 and 31st of July 2013.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
115

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

November 1, 2010

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 2, 2011

Completed
9.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

October 6, 2021

Status Verified

October 1, 2021

Enrollment Period

10.3 years

First QC Date

September 1, 2011

Last Update Submit

October 5, 2021

Conditions

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Community sample consisting of consecutive mild traumatic brain injury patients metting the enrollment criteria.

You may qualify if:

  • WHO's mtbi criteria
  • Inhabitant of Pirkanmaa hospital district
  • Age between 18 and 60 years

You may not qualify if:

  • Detrimental alcohol use
  • Drug addiction
  • Chronic neurological disease
  • Earlier brain injury
  • Diagnosed psychiatric disease
  • Hearing or sight deficiency
  • Native language other than finnish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tampere University Hospital

Tampere, 33521, Finland

Location

Biospecimen

Retention: SAMPLES WITH DNA

1. 10ml whole blood 2. 10ml EDTA-blood x2

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Teemu M. Luoto, M.D.

    Tampere University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Researcher

Study Record Dates

First Submitted

September 1, 2011

First Posted

September 2, 2011

Study Start

November 1, 2010

Primary Completion

February 1, 2021

Study Completion

February 1, 2021

Last Updated

October 6, 2021

Record last verified: 2021-10

Locations