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

NCT ID: NCT02358772

Last Updated: 2016-08-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

658 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-02-28

Study Completion Date

2016-07-31

Brief Summary

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

Detailed Description

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Conditions

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Ischemic Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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).

thrombolysis in a pre-hospital setting (STEMO concept)

Intervention Type OTHER

In-hospital thrombolysis

Patients with acute ischemic stroke who receive thrombolytic therapy after admission to an University Hospital.

No interventions assigned to this group

Interventions

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thrombolysis in a pre-hospital setting (STEMO concept)

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Heinrich J Audebert

Prof. Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Heinrich J Audebert, MD

Role: PRINCIPAL_INVESTIGATOR

Center for Stroke Research Berlin, Charité Universitätsmedizin Berlin

Locations

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Charité

Berlin, State of Berlin, Germany

Site Status

Countries

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Germany

References

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Ebinger M, Winter B, Wendt M, Weber JE, Waldschmidt C, Rozanski M, Kunz A, Koch P, Kellner PA, Gierhake D, Villringer K, Fiebach JB, Grittner U, Hartmann A, Mackert BM, Endres M, Audebert HJ; STEMO Consortium. Effect of the use of ambulance-based thrombolysis on time to thrombolysis in acute ischemic stroke: a randomized clinical trial. JAMA. 2014 Apr 23-30;311(16):1622-31. doi: 10.1001/jama.2014.2850.

Reference Type BACKGROUND
PMID: 24756512 (View on PubMed)

Kunz A, Ebinger M, Geisler F, Rozanski M, Waldschmidt C, Weber JE, Wendt M, Winter B, Zieschang K, Fiebach JB, Villringer K, Erdur H, Scheitz JF, Tutuncu S, Bollweg K, Grittner U, Kaczmarek S, Endres M, Nolte CH, Audebert HJ. Functional outcomes of pre-hospital thrombolysis in a mobile stroke treatment unit compared with conventional care: an observational registry study. Lancet Neurol. 2016 Sep;15(10):1035-43. doi: 10.1016/S1474-4422(16)30129-6. Epub 2016 Jul 16.

Reference Type BACKGROUND
PMID: 27430529 (View on PubMed)

Nolte CH, Ebinger M, Scheitz JF, Kunz A, Erdur H, Geisler F, Braemswig TB, Rozanski M, Weber JE, Wendt M, Zieschang K, Fiebach JB, Villringer K, Grittner U, Kaczmarek S, Endres M, Audebert HJ. Effects of Prehospital Thrombolysis in Stroke Patients With Prestroke Dependency. Stroke. 2018 Mar;49(3):646-651. doi: 10.1161/STROKEAHA.117.019060. Epub 2018 Feb 19.

Reference Type DERIVED
PMID: 29459395 (View on PubMed)

Other Identifiers

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STEMO_Outcome Analysis

Identifier Type: -

Identifier Source: org_study_id

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