Introduction of Protein S100 in Diagnostics in Minor Brain Injury Patients at Our Hospital
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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 |
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) |
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 |
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
Contacts and Locations| Switzerland | |
| Kantonsspital Münsterlingen | |
| Münsterlingen, Thurgau, Switzerland, CH-8596 | |
| 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 Pathologic Processes Protein S Anticoagulants |
Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 17, 2013