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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00574262
Other study ID # ClinPathStroke
Secondary ID
Status Recruiting
Phase N/A
First received November 23, 2007
Last updated January 12, 2010
Start date October 2007
Est. completion date April 2009

Study information

Verified date November 2007
Source University Hospital Muenster
Contact Wolf Rüdiger Schäbitz, MD
Phone 0049-251-8345235
Email schabitz@uni-muenster.de
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Observational

Clinical Trial Summary

The purpose of the study is to evaluate the quality of care on a 16 bed stroke unit by using a new developed clinical pathway.


Recruitment information / eligibility

Status Recruiting
Enrollment 400
Est. completion date April 2009
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- admission to the stroke unit of the university hospital in Muenster, Germany

- acute ischemic stroke or transient ischemic attack

Exclusion Criteria:

- intracerebral haemorrhage

- neurological symptoms due to other pathology than acute ischemic stroke or transient ischemic attack

- intraarterial thrombolysis

- necessity of artificial ventilation

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Germany Department of Neurology, University Hospital of Muenster Muenster

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Muenster

Country where clinical trial is conducted

Germany, 

References & Publications (3)

Heuschmann PU, Biegler MK, Busse O, Elsner S, Grau A, Hasenbein U, Hermanek P, Janzen RW, Kolominsky-Rabas PL, Kraywinkel K, Lowitzsch K, Misselwitz B, Nabavi DG, Otten K, Pientka L, von Reutern GM, Ringelstein EB, Sander D, Wagner M, Berger K. Development and implementation of evidence-based indicators for measuring quality of acute stroke care: the Quality Indicator Board of the German Stroke Registers Study Group (ADSR). Stroke. 2006 Oct;37(10):2573-8. Epub 2006 Sep 7. Erratum in: Stroke. 2007 Jan;38(1):206. Kolominisky-Rabas, Peter L [corrected to Kolominsky-Rabas, Peter L]. — View Citation

Kwan J. Care pathways for acute stroke care and stroke rehabilitation: from theory to evidence. J Clin Neurosci. 2007 Mar;14(3):189-200. Review. — View Citation

Taylor WJ, Wong A, Siegert RJ, McNaughton HK. Effectiveness of a clinical pathway for acute stroke care in a district general hospital: an audit. BMC Health Serv Res. 2006 Feb 23;6:16. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary frequency of patients monitored according to the specific german procedure standard (OPS-code 8-981) (preset target 90 - 95 %) duration of stay on stroke unit No
Secondary frequency of stroke been classified according to the TOAST criteria (preset target 55 - 65 %) duration of stay on stroke unit No
Secondary frequency of initiated or improved antithrombotic secondary prevention (preset target 90 - 95 %) duration of stay on stroke unit No
Secondary frequency of initiated or improved statin therapy (preset target 40 - 50 %) duration of stay on stroke unit No
Secondary frequency of totally completed clinical diagnostics regarding the etiology of the stroke (preset target 60 -70 %) duration of stay on stroke unit No
Secondary frequency of initiated or improved antihypertension therapy and reduction of systolic and diastolic blood pressure by more than 10 mmHg (preset target 60 - 70 %) duration of stay on stroke unit No
Secondary frequency of a reduction on the NIH-SS by at least two points (preset target 50 - 60 %) duration of stay on stroke unit No
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