NCT02836951

Brief Summary

Novel biomarkers of traumatic brain injury (TBI) have been discovered in laboratory animal models. The objective of this study is to find whether similar markers are detectable in the body fluids of human subjects that have sustained a TBI.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2016

Shorter than P25 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 15, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 19, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2017

Completed
Last Updated

September 3, 2020

Status Verified

September 1, 2020

Enrollment Period

5 months

First QC Date

July 15, 2016

Last Update Submit

September 1, 2020

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (2)

  • Presence of lectin-complexes in patients with TBI

    There is a difference in the intensity of immuno-fluorescence readings between TBI patients and healthy controls. Different lectin bound complexes will be studied in body fluid samples collected from the patients (the trial is not following the patients nor is it intended to evaluate clinical outcome).

    Two years

  • Characterization of molecule structure of lectin-complexes

    Molecular characterization of lectin-complexes by HPLC (high performance liquid chromatography) and MS (mass spectrometry) analysis. Samples retrieved from the patients are being analyzed comparing head injured to healthy controls. No follow-up of the patients and no clinical evaluation.

    Two years

Study Arms (2)

Patient

This group consists of patients that are hospitalized due to a head injury. Samples of blood, urine and plasma will taken from these subjects and the fluids will be analyzed for novel biomarkers using a biochemical assay.

Other: Withdrawal of blood

Healthy controls

This group consists of healthy volunteers. Samples of blood, urine and plasma will taken from these subjects and the fluids will be analyzed for novel biomarkers using a biochemical assay.

Other: Withdrawal of blood

Interventions

Withdrawal of bloodOTHER

Withdrawal of blood

Healthy controlsPatient

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Study population will include patients that are hospitalized due to a suspected traumatic brain injury. Identical number of healthy volunteers will serve as controls.

You may qualify if:

  • Patient is hospitalized because of a head trauma and suspected TBI.
  • Age 18 or above. The subject (including the control subjects) must be an independent adult who is not under guardianship.
  • The patient, or the next of kin in the case of an incompetent person, has signed the Informed consent. This concerns the control subjects, too.
  • The samples can be collected during regular office hours.
  • The patient needs lumbar puncture for treatment reasons. This is not a limiting criterion however. If it is difficult to find an adequate number of patients for lumbar puncture, CSF samples of some patients can be omitted after the study coordinator's consideration.

You may not qualify if:

  • The subject has been found positive for HIV or hepatitis-B in the involved laboratory studies.
  • The subject has a chronic mental disorder which is mentioned on the sickness insurance card.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turku University Hospital (Tyks)

Turku, Finland

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood, urine, and saliva.

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

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

Study Officials

  • Jaakko Rinne, Professor

    University of Turku

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2016

First Posted

July 19, 2016

Study Start

September 1, 2016

Primary Completion

January 31, 2017

Study Completion

January 31, 2017

Last Updated

September 3, 2020

Record last verified: 2020-09

Locations

FI(1)