NCT02358772

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
658

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

February 4, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 9, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

August 10, 2016

Status Verified

August 1, 2016

Enrollment Period

4.3 years

First QC Date

February 4, 2015

Last Update Submit

August 8, 2016

Conditions

Ischemic Stroke

Keywords

strokethrombolysisSTEMO

Outcome Measures

Primary Outcomes (1)

  • modified Rankin Scale (mRS) score

    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 Outcomes (3)

  • modified Rankin Scale (mRS) score

    three months after event

  • modified Rankin Scale (mRS) score

    three months after event

  • modified Rankin Scale (mRS) score

    three months after event

Study Arms (2)

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.

Interventions

thrombolysis in a pre-hospital setting (STEMO concept)OTHER
Pre-hospital thrombolysis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

acute ischemic stroke patients with thrombolytic treatment

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité

Berlin, State of Berlin, 10117, Germany

Location

Related Publications (3)

  • 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.

    PMID: 24756512BACKGROUND

  • 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.

    PMID: 27430529BACKGROUND

  • 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.

    PMID: 29459395DERIVED

MeSH Terms

Conditions

Ischemic StrokeStroke

Interventions

Fibrinolytic Agents

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Fibrin Modulating AgentsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesCardiovascular AgentsTherapeutic UsesHematologic Agents

Study Officials

  • Heinrich J Audebert, MD

    Center for Stroke Research Berlin, Charité Universitätsmedizin Berlin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

February 4, 2015

First Posted

February 9, 2015

Study Start

February 1, 2011

Primary Completion

June 1, 2015

Study Completion

July 1, 2016

Last Updated

August 10, 2016

Record last verified: 2016-08

Locations

DE(1)