Comparison of Pre-hospital and In-hospital Iv-tPA Stroke Treatment

August 8, 2016 updated by: Heinrich J Audebert, Charite University, Berlin, Germany
This is a comparison of clinical outcomes between a pre-hospital and an in-hospital thrombolysis patient registry.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

658

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Charité

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

acute ischemic stroke patients with thrombolytic treatment

Description

Inclusion Criteria:

  • Acute ischemic stroke diagnosis with thrombolytic treatment
  • Admission via EMS
  • Known premorbid status of need of assistance
  • NIHSS before treatment available
  • Time of onset (or last well seen) between 4:00am and 10:30pm

Exclusion Criteria:

  • Unknown time of onset
  • In-hospital thrombolysis despite decision against treatment because of contraindications in STEMO

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pre-hospital thrombolysis
Patients with acute ischemic stroke who are cared in a specialized STroke Emergency MObile (STEMO) before admission to the Hospital and receive thrombolytic therapy (either in STEMO or in Hospital).
Other: thrombolysis in a pre-hospital setting (STEMO concept)
In-hospital thrombolysis
Patients with acute ischemic stroke who receive thrombolytic therapy after admission to an University Hospital.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
modified Rankin Scale (mRS) score
Time Frame: three months after event
dichotomized mRS 0-1 and 2-6 in patients who lived at home without assistance prior to the index stroke.
three months after event

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
modified Rankin Scale (mRS) score
Time Frame: three months after event
dichotomized mRS 1-3 and 4-6
three months after event
modified Rankin Scale (mRS) score
Time Frame: three months after event
mortality (mRS=6)
three months after event
modified Rankin Scale (mRS) score
Time Frame: three months after event
ordinal analysis across whole mRS range
three months after event

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Investigators

  • Principal Investigator: Heinrich J Audebert, MD, Center for Stroke Research Berlin, Charité Universitätsmedizin Berlin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

February 4, 2015

First Submitted That Met QC Criteria

February 6, 2015

First Posted (Estimate)

February 9, 2015

Study Record Updates

Last Update Posted (Estimate)

August 10, 2016

Last Update Submitted That Met QC Criteria

August 8, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STEMO_Outcome Analysis

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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