Introduction of Protein S100 in Diagnostics in Minor Brain Injury Patients at Our Hospital (S100)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01122212
Recruitment Status : Completed
First Posted : May 13, 2010
Last Update Posted : April 21, 2015
Roche Diagnostic Ltd.
Information provided by (Responsible Party):
Kantonsspital Münsterlingen

Brief Summary:
In Patients with minor head injury measurement of protein S100 will be introduced to the emergency departement as another tool to rule out intracerebral bleeding.

Condition or disease
Intracerebral Hemorrhage

Detailed Description:

Severe intracerebral bleeding is still a complication even in obvious minor head injury (MHI) that makes the use of CT scanning necessary in patients with only few signs of intracerebral injury. To reduce the number of cerebral CT scans without pathologic findings measurement of protein S100 level in serum will be used in the emergency departement (ED) at our hospital.

Our hypothesis: with measurement of S100 levels cCT scans and inpatient treatment can be reduced, radiation and costs can be reduced.

From January 1st 2010 for 3-6 months all patients with head injury (all GCS) will be tested for their initial S100 level. Cut off level is set at 0,105ng/ml. During this period test results will be blinded. Decisions for further diagnostics (x-ray, cCT) and inpatient vs. outpatient treatment are made on clinical impressions as they are made now. The test results will be monitored and compared with clinical cases. Sensitivity, specificity, positive and negative predictive values will be measured.

The aim is to identify patients without risk for intracerebral bleeding (ie S100 level lower than 0,105ng/ml). Those can be managed in an outpatient way. All other patients will be diagnosed and treated as it is now.

If the test will not miss one intracranial bleeding and will save cCT scans and inpatient treatment, measurement of protein S100 will become a routine diagnostic in our ED for patients with MHI.

Study Type : Observational
Actual Enrollment : 128 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Introduction of Protein S100 in the Routine Diagnostics in Patients With Minor Head Injury
Study Start Date : January 2010
Actual Primary Completion Date : July 2010
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Biospecimen Retention:   Samples With DNA
venous blood (Serum)

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients older than 3 years entering the ED of the Kantonsspital Münsterlingen with the history of a MHI during the last 6 hours and after getting informed consent

Inclusion Criteria:

  • history of MHI during last 6 hours
  • older than 3 years

Exclusion Criteria:

  • more than 6 hours after MHI
  • younger than 4 years
  • informed consent not given

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01122212

Kantonsspital Münsterlingen
Münsterlingen, Thurgau, Switzerland, CH-8596
Sponsors and Collaborators
Kantonsspital Münsterlingen
Roche Diagnostic Ltd.
Principal Investigator: Martin Blay, MD Kantonsspital Münsterlingen

Responsible Party: Kantonsspital Münsterlingen Identifier: NCT01122212     History of Changes
Other Study ID Numbers: S100-01 2010
First Posted: May 13, 2010    Key Record Dates
Last Update Posted: April 21, 2015
Last Verified: January 2012

Keywords provided by Kantonsspital Münsterlingen:
intracerebral hemorrhage
ct scans
protein s100
inpatient treatment

Additional relevant MeSH terms:
Cerebral Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Protein S