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

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

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.

Study Overview

• Status: Completed
• Conditions: 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
• Enrollment (Actual): 128

Contacts and Locations

Study Locations

• Switzerland
  • Thurgau
    • Münsterlingen, Thurgau, Switzerland, CH-8596
      • Kantonsspital Münsterlingen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Kantonsspital Münsterlingen
• Collaborators: Roche Diagnostic Ltd.
• Investigators: Principal Investigator: Martin Blay, MD, Kantonsspital Münsterlingen

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): January 1, 2011

Study Registration Dates

• First Submitted: May 11, 2010
• First Submitted That Met QC Criteria: May 12, 2010
• First Posted (Estimate): May 13, 2010

Study Record Updates

• Last Update Posted (Estimate): April 21, 2015
• Last Update Submitted That Met QC Criteria: April 17, 2015
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Keywords: intracerebral hemorrhage; ct scans; protein s100; inpatient treatment
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hemorrhages; Hemorrhage; Cerebral Hemorrhage
• Other Study ID Numbers: S100-01 2010