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

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ClinicalTrials.gov Identifier: NCT02358772
Recruitment Status : Completed
First Posted : February 9, 2015
Last Update Posted : August 10, 2016
Sponsor:
Information provided by (Responsible Party):
Heinrich J Audebert, Charite University, Berlin, Germany

Brief Summary:
This is a comparison of clinical outcomes between a pre-hospital and an in-hospital thrombolysis patient registry.

Condition or disease Intervention/treatment
Ischemic Stroke Other: thrombolysis in a pre-hospital setting (STEMO concept)

Study Type : Observational [Patient Registry]
Actual Enrollment : 658 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Study Start Date : February 2011
Actual Primary Completion Date : June 2015
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. modified Rankin Scale (mRS) score [ Time Frame: three months after event ]
    dichotomized mRS 1-3 and 4-6

  2. modified Rankin Scale (mRS) score [ Time Frame: three months after event ]
    mortality (mRS=6)

  3. modified Rankin Scale (mRS) score [ Time Frame: three months after event ]
    ordinal analysis across whole mRS range



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
acute ischemic stroke patients with thrombolytic treatment
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02358772


Locations
Germany
Charité
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Principal Investigator: Heinrich J Audebert, MD Center for Stroke Research Berlin, Charité Universitätsmedizin Berlin

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Heinrich J Audebert, Prof. Dr. med., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT02358772     History of Changes
Other Study ID Numbers: STEMO_Outcome Analysis
First Posted: February 9, 2015    Key Record Dates
Last Update Posted: August 10, 2016
Last Verified: August 2016

Keywords provided by Heinrich J Audebert, Charite University, Berlin, Germany:
stroke
thrombolysis
STEMO

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases