Ischemic StrokeNCT02358772
Comparison of Pre-hospital and In-hospital Iv-tPA Stroke Treatment
An observational study of Ischemic Stroke, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
This is a comparison of clinical outcomes between a pre-hospital and an in-hospital thrombolysis patient registry. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- thrombolysis in a pre-hospital setting (STEMO concept)
- How many people
- 658 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2011to Jul 2016
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: acute ischemic stroke patients with thrombolytic treatment
Who may be able to join
- 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
Who cannot join
- Unknown time of onset
- In-hospital thrombolysis despite decision against treatment because of contraindications in STEMO
Trial locations and contacts
1 site in 1 country.
About this study
This is a comparison of clinical outcomes between a pre-hospital and an in-hospital thrombolysis patient registry.
- Conditions
- Ischemic Stroke
- Being tested
- thrombolysis in a pre-hospital setting (STEMO concept)
- Keywords
- stroke, thrombolysis, STEMO
- Medical subject headings
- Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thrombolysis in a pre-hospital setting (STEMO concept)Other
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: three months after event
Secondary outcomes (3)
modified Rankin Scale (mRS) score
dichotomized mRS 1-3 and 4-6
Measured: three months after event
modified Rankin Scale (mRS) score
mortality (mRS=6)
Measured: three months after event
modified Rankin Scale (mRS) score
ordinal analysis across whole mRS range
Measured: three months after event
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2015 (estimated)
- Study startFeb 2011
- Primary completionJun 2015
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 658 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heinrich J Audebert, Charite University, Berlin, Germany
- Investigators
- Heinrich J Audebert, MD, Principal investigator, Center for Stroke Research Berlin, Charité Universitätsmedizin Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02358772
- Sponsor's protocol ID
- STEMO_Outcome Analysis
- Status last verified
- Aug 2016
- First submitted
- 4 Feb 2015
- Last updated
- 10 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24756512Kunz 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.
PubMed 27430529Nolte 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.
PubMed 29459395
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Pre-hospital and In-hospital Iv-tPA Stroke Treatment
- ClinicalTrials.gov ID
- NCT02358772
- Acronym / sponsor ID
- STEMO_Outcome Analysis
- Conditions
- Ischemic Stroke
- Keywords
- stroke, thrombolysis, STEMO
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 658 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 9 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a comparison of clinical outcomes between a pre-hospital and an in-hospital thrombolysis patient registry.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-hospital thrombolysis | – | Other: thrombolysis in a pre-hospital setting (STEMO concept)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). |
| In-hospital thrombolysis | – | –Patients with acute ischemic stroke who receive thrombolytic therapy after admission to an University Hospital. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- acute ischemic stroke patients with thrombolytic treatment
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Unknown time of onset
- In-hospital thrombolysis despite decision against treatment because of contraindications in STEMO
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| thrombolysis in a pre-hospital setting (STEMO concept) | Other | Pre-hospital thrombolysis |
Primary outcome
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.
3 secondary outcomes
modified Rankin Scale (mRS) score
Time frame: three months after event
modified Rankin Scale (mRS) score
Time frame: three months after event
modified Rankin Scale (mRS) score
Time frame: three months after event
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2016.
- Background: PubMed 24756512Ebinger 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.
- Background: PubMed 27430529Kunz 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.
- Derived from this study: PubMed 29459395Nolte 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.
Related trials for Ischemic Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
Visual Field Defect, Peripheral, Stroke
Recruiting
Biomarkers of Paired VNS
Stroke, Ischemic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heinrich J Audebert, MD principal investigator
Center for Stroke Research Berlin, Charité Universitätsmedizin Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
modified Rankin Scale (mRS) score (time frame: three months after event). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02358772, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2016.