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

Intracerebral Hemorrhage Clinical Trial

— S100  

Official title:

Introduction of Protein S100 in the Routine Diagnostics in Patients With Minor Head Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01122212
• Other study ID #: S100-01 2010
• Status: Completed
• Phase: N/A
• First received: May 11, 2010
• Last updated: April 17, 2015
• Start date: January 2010
• Est. completion date: January 2011

Study information

• Verified date: January 2012
• Source: Kantonsspital Münsterlingen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: January 2011
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Intracerebral Hemorrhage

Locations

Country	Name	City	State
Switzerland	Kantonsspital Münsterlingen	Münsterlingen	Thurgau

Sponsors (2)

Lead Sponsor	Collaborator
Kantonsspital Münsterlingen	Roche Diagnostic Ltd.

Country where clinical trial is conducted

Switzerland,