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OpenTrials
Completed

NCT Number: NCT02358772

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

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

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Key information

Conditions

Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Charité

Berlin, State of Berlin, 10117, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

thrombolysis in a pre-hospital setting (STEMO concept)

Other

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Important dates

Study start
2011
Primary completion
2015
Study completion
2016
First posted
Feb 9, 2015
Registry last updated
Aug 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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