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

Ischemic Stroke Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02358772
• Other study ID #: STEMO_Outcome Analysis
• Status: Completed
• Phase: N/A
• First received: February 4, 2015
• Last updated: August 8, 2016
• Start date: February 2011
• Est. completion date: July 2016

Study information

• Verified date: August 2016
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 658
• Est. completion date: July 2016
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Ischemic Stroke
• Stroke

Intervention

Other:
• thrombolysis in a pre-hospital setting (STEMO concept)

Locations

Country	Name	City	State
Germany	Charité	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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. — View Citation

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, Tütüncü 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 Jul 15. pii: S1474-4422(16)30129-6. doi: 10.1016/S1474-4422(16)30129-6. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	modified Rankin Scale (mRS) score	dichotomized mRS 1-3 and 4-6	three months after event	No
Secondary	modified Rankin Scale (mRS) score	mortality (mRS=6)	three months after event	No
Secondary	modified Rankin Scale (mRS) score	ordinal analysis across whole mRS range	three months after event	No