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

This study has been completed.
Sponsor:
Collaborator:
Roche Diagnostic Ltd.
Information provided by (Responsible Party):
Kantonsspital Münsterlingen
ClinicalTrials.gov Identifier:
NCT01122212
First received: May 11, 2010
Last updated: January 9, 2012
Last verified: January 2012
  Purpose

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
Intracerebral Bleeding

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Introduction of Protein S100 in the Routine Diagnostics in Patients With Minor Head Injury

Resource links provided by NLM:


Further study details as provided by Kantonsspital Münsterlingen:

Biospecimen Retention:   Samples With DNA

venous blood (Serum)


Enrollment: 128
Study Start Date: January 2010
Study Completion Date: January 2011
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   4 Years and older
Genders Eligible for Study:   Both
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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01122212

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

No publications provided

Responsible Party: Kantonsspital Münsterlingen
ClinicalTrials.gov Identifier: NCT01122212     History of Changes
Other Study ID Numbers: S100-01 2010
Study First Received: May 11, 2010
Last Updated: January 9, 2012
Health Authority: Switzerland: Ethikkommission

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

Additional relevant MeSH terms:
Hemorrhage
Wounds and Injuries
Pathologic Processes
Protein S
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014