StrokeB-SPATIALNCT03027453
Berlin - SPecific Acute Treatment in Ischemic or hAemorrhagic Stroke With Long Term Follow-up
An observational study of Stroke, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The B-SPATIAL-Registry will provide a tool of quality assessment for stroke specific Treatments such as endovascular treatment. It will also enable the participating hospitals to compare the quality of care of their facility. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- How many people
- 15,246 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2016to Dec 2021
- 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: Stroke patients (ischemic and haemorrhagic)
Who may be able to join
- Patients with hospital main discharge diagnoses according to ICD 10: Ischemic stroke (I63) or TIA (G45.0-G45.3 and G45.5-G45.9, respectively) and
- Onset of symptoms within 6 hours of hospital arrival
- In patients with TIA diagnosis: Persistent neurological symptoms at hospital arrival (emergency department documentation)
- Patients with main discharge diagnosis of intracranial hemorrhage and symptom onset within 6 hours of hospital admission
- Patients with other main discharge diagnoses and documented intravenous thrombolysis (OPS 8-020.8) in order to monitor the treatment rate of stroke mimics
Who cannot join
- Symptom remission before EMS arrival or hospital arrival (if no EMS Transport)
- Primary subarachnoid hemorrhage
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Berlin - Specific Acute Treatment in Ischemic or Haemorrhagic Stroke With Long Term Follow-up
The B-SPATIAL-Registry will provide a tool of quality assessment for stroke specific Treatments such as endovascular treatment. It will also enable the participating hospitals to compare the quality of care of their facility. At the same time, B-SPATIAL will provide an opportunity of scientific evaluation of new therapeutic procedures or specific treatments in stroke (i.e. reversal of oral anticoagulation in intracerebral hemorrhage or intravenous thrombolysis), not sufficiently investigated so far. Finally, the B-SPATIAL Registry will allow for an identification of key quality indicators that assure valid quality assessment aiming at a reduced documentation load for future quality management.
Read the detailed description
- Background Quality assessment of acute stroke care is organized in regional stroke registries in Germany - for the federal state of Berlin in the Berlin Stroke Registry (BSR). The current documentation of the Berlin Stroke Registry is focused on the documentation of process quality in participating hospitals. So far, outcome quality is only assessed by surrogate parameters such as complications and mortality during in-hospital stay. However, according to consensus recommendations, disability-free survival versus death and dependency is the most important outcome measure after acute stroke. Because of the high variability of the clinical course after stroke, this outcome is generally assessed after three months by using the modified Rankin Scale (mRS).
- Motivation In early 2015, several published trials showed that mechanical thrombectomy improves the prognosis of ischemic stroke patients with acute large artery occlusion of proximal brain supplying arteries. Currently, this invasive catheter based treatment is not available in many hospitals with acute Stroke Unit. It is likely that the quality of technical procedures depends on the expertise and experience of treating interventionalists. Current studies suggest a close relationship between effectiveness of the approach and time to treatment, similar to intravenous thrombolysis. This time dependency makes prehospital triage more challenging because selection of the appropriate facility is likely to influence patient outcome. Intracerebral hemorrhage (ICH) is less frequent than ischemic stroke but is associated with worse prognosis. Recent studies suggest that blood pressure lowering may improve prognosis if started during the hyperacute phase of ICH. With limited scientific evidence, many patients undergo neurosurgical intervention. It remains unclear whether delivery of hemorrhagic stroke patients to hospitals with neurosurgery leads to better outcome. Hence, pre-hospital care with delivery to more or less specialized clinical facilities may have a crucial impact for both subtypes of stroke. The introduction of specialized stroke ambulances (Stroke Emergency Mobiles, STEMOs) opens new avenues for pre-hospital stroke diagnosis, treatment and patient triage. The effects of STEMO care are planned to be assessed by the parallel B-PROUD-Study (NCT02869386).
- Purpose The B-SPATIAL-Registry will provide a tool of quality assessment for new specific treatments. It will also enable the participating hospitals to compare the quality of care of their own facility. Because this registry represents an quality monitoring initiative, the telephone follow-up is collected with an opt-out solution, allowing to decline participation after the patients are informed on the follow-up telephone call at discharge and through a letter send one month prior to the actual call. As written informed consent is not required, this method will facilitate a high follow-up rate particularly in patients with severe neurological deficits or treated in non-academic hospitals. In B-SPATIAL we want to identify key quality indicators that assure valid quality assessment despite reduced documentation load in future quality management. Specific Aims of the registry:
- Assessment of proportions of patients receiving specific treatments (based on total number of eligible)
- Evaluation of treatment specific indicators for process quality including pre-hospital care
- Evaluation of outcome quality (survival, level of disability and quality of life after 3 months) Pre-specified analyses: Ischemic stroke
- Intravenous hospital based tPA rate in treatment candidates
- Time to treatment in intravenous tPA
- Rate of secondary interhospital referral
- Proportions of patients receiving endovascular thrombectomy
- Time to groin puncture and reperfusion in patients with endovascular thrombectomy
- Proportions of used devices
- Proportions of patients with general/non general anesthesia (conscious sedation)
- Secondary intracranial hemorrhage
- Functional outcome according to mRS at 3 months Hemorrhagic stroke
- Time to start of intravenous antihypertensive treatment
- Time to start of PCC in patients with OAC or specific reversal of NOACs
- Rate of surgical treatments
- Rate of secondary interhospital referral
- Enlargement and final volume of ICH
- Functional outcome according to mRS at 3 months Data sources The documentation will include pre-hospital, in-hospital and post-discharge processes such as:
- Emergency medical service (EMS)
- Acute in-hospital stay
- Follow-up (first choice: telephone, second choice: written questionnaire, third choice: FU regarding vital status from registration offices)
- Patients In order to ensure valid analysis of treatment rates in participating hospitals, patients will be included according to the following inclusion criteria:
- Patients with hospital main discharge diagnoses according to ICD 10: Ischemic stroke (I63) or TIA (G45.0-G45.3 and G45.5-G45.9, respectively) and
- Onset of symptoms within 6 hours of hospital arrival
- In patients with TIA diagnosis: Persistent neurological symptoms at hospital arrival (emergency department documentation)
- Patients with main discharge diagnosis of intracranial hemorrhage and hospital admission within 6 hours of stroke onset.
- Patients with other main discharge diagnoses and documented intravenous thrombolysis (OPS 8-020.8) in order to monitor the treatment rate of stroke mimics
- Data documentation
- Data will be entered in all participating hospitals via remote access to the databank
- Data will be entered with pseudonyms but identification will only be possible in local hospitals via register-logs that will be safely stored in the hospitals.
- Databank characteristics
- For data entry, we will use the REDcap databank software with access from all participating hospitals.
- Dedicated computers will be used and safely stored in participating hospitals. Encryption and password algorithms will protect the remote access to the databank.
- The registry databank will be stored and hosted on a protected server of the Charité IT department.
- For statistical evaluation, the REDcap databank will be exported in an SPSS-based data format, stored on the server of the Center for Stroke Research Berlin (CSB).
- Responsibilities
- Data entry: Study nurses in participating hospitals
- Databank in Charité IT-center: Charité IT department and databank manager of the Clinical Research Units
- Scientific evaluation: PI of CSB (Jessica L.Rohmann in cooperation with Heinrich J. Audebert, Martin Ebinger and Christian Nolte)
- Conditions
- Stroke
- Medical subject headings
- Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Rankin Scale
Assessment of functional outcome over the entire range of the modified Rankin Scale
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2017 (estimated)
- Study startJan 2016
- Primary completionApr 2021
- Study completionDec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for 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
- 15,246 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Berliner Feuerwehr, Bundeswehrkrankenhaus Berlin, DRK-Kliniken Berlin Köpenick, Evangelisches Krankenhaus Königin Elisabeth Herzberge, Helios Klinikum Berlin-Buch, Jüdisches Krankenhaus Berlin, Park-Klinik Weissensee, Schlosspark-Klinik, Unfallkrankenhaus Berlin, Vivantes Auguste-Viktoria-Klinikum, Vivantes Klinikum im Friedrichshain, Vivantes Humboldt-Klinikum, Vivantes Clinic Neukölln, Vivantes Klinikum Spandau
- Responsible party
- Principal investigator, Heinrich J Audebert, Charite University, Berlin, Germany
- Investigators
- Jessica L Rohmann, Principal investigator, Center for Stroke Research Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03027453
- Sponsor's protocol ID
- B-SPATIAL
- Acronym
- B-SPATIAL
- Status last verified
- Sep 2022
- First submitted
- 19 Jan 2017
- Last updated
- 13 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- 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 24756512Krebes S, Ebinger M, Baumann AM, Kellner PA, Rozanski M, Doepp F, Sobesky J, Gensecke T, Leidel BA, Malzahn U, Wellwood I, Heuschmann PU, Audebert HJ. Development and validation of a dispatcher identification algorithm for stroke emergencies. Stroke. 2012 Mar;43(3):776-81. doi: 10.1161/STROKEAHA.111.634980. Epub 2012 Jan 5.
PubMed 22223240Ebinger M, Fiebach JB, Audebert HJ. Mobile computed tomography: prehospital diagnosis and treatment of stroke. Curr Opin Neurol. 2015 Feb;28(1):4-9. doi: 10.1097/WCO.0000000000000165.
PubMed 25490196Wendt M, Ebinger M, Kunz A, Rozanski M, Waldschmidt C, Weber JE, Winter B, Koch PM, Freitag E, Reich J, Schremmer D, Audebert HJ; STEMO Consortium. Improved prehospital triage of patients with stroke in a specialized stroke ambulance: results of the pre-hospital acute neurological therapy and optimization of medical care in stroke study. Stroke. 2015 Mar;46(3):740-5. doi: 10.1161/STROKEAHA.114.008159. Epub 2015 Jan 29.
PubMed 25634000Kunz 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 27430529Rohmann JL, Huerta-Gutierrez R, Audebert HJ, Kurth T, Piccininni M. Adjusted horizontal stacked bar graphs ("Grotta bars") for consistent presentation of observational stroke study results. Eur Stroke J. 2023 Mar;8(1):370-379. doi: 10.1177/23969873221149464. Epub 2023 Jan 13.
PubMed 37021164
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Berlin - Specific Acute Treatment in Ischemic or Haemorrhagic Stroke With Long Term Follow-up
- ClinicalTrials.gov ID
- NCT03027453
- Acronym / sponsor ID
- B-SPATIAL / B-SPATIAL
- Conditions
- Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15,246 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Berliner Feuerwehr, Bundeswehrkrankenhaus Berlin, DRK-Kliniken Berlin Köpenick, Evangelisches Krankenhaus Königin Elisabeth Herzberge, Helios Klinikum Berlin-Buch, Jüdisches Krankenhaus Berlin, Park-Klinik Weissensee, Schlosspark-Klinik, Unfallkrankenhaus Berlin, Vivantes Auguste-Viktoria-Klinikum, Vivantes Klinikum im Friedrichshain, Vivantes Humboldt-Klinikum, Vivantes Clinic Neukölln, Vivantes Klinikum Spandau
- Study start
- Jan 2016
- Primary completion
- Apr 2021 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 23 Jan 2017 (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.
The B-SPATIAL-Registry will provide a tool of quality assessment for stroke specific Treatments such as endovascular treatment. It will also enable the participating hospitals to compare the quality of care of their facility. At the same time, B-SPATIAL will provide an opportunity of scientific evaluation of new therapeutic procedures or specific treatments in stroke (i.e. reversal of oral anticoagulation in intracerebral hemorrhage or intravenous thrombolysis), not sufficiently investigated so far. Finally, the B-SPATIAL Registry will allow for an identification of key quality indicators that assure valid quality assessment aiming at a reduced documentation load for future quality management.
Detailed description
- Background Quality assessment of acute stroke care is organized in regional stroke registries in Germany - for the federal state of Berlin in the Berlin Stroke Registry (BSR). The current documentation of the Berlin Stroke Registry is focused on the documentation of process quality in participating hospitals. So far, outcome quality is only assessed by surrogate parameters such as complications and mortality during in-hospital stay. However, according to consensus recommendations, disability-free survival versus death and dependency is the most important outcome measure after acute stroke. Because of the high variability of the clinical course after stroke, this outcome is generally assessed after three months by using the modified Rankin Scale (mRS).
- Motivation In early 2015, several published trials showed that mechanical thrombectomy improves the prognosis of ischemic stroke patients with acute large artery occlusion of proximal brain supplying arteries. Currently, this invasive catheter based treatment is not available in many hospitals with acute Stroke Unit. It is likely that the quality of technical procedures depends on the expertise and experience of treating interventionalists. Current studies suggest a close relationship between effectiveness of the approach and time to treatment, similar to intravenous thrombolysis. This time dependency makes prehospital triage more challenging because selection of the appropriate facility is likely to influence patient outcome. Intracerebral hemorrhage (ICH) is less frequent than ischemic stroke but is associated with worse prognosis. Recent studies suggest that blood pressure lowering may improve prognosis if started during the hyperacute phase of ICH. With limited scientific evidence, many patients undergo neurosurgical intervention. It remains unclear whether delivery of hemorrhagic stroke patients to hospitals with neurosurgery leads to better outcome. Hence, pre-hospital care with delivery to more or less specialized clinical facilities may have a crucial impact for both subtypes of stroke. The introduction of specialized stroke ambulances (Stroke Emergency Mobiles, STEMOs) opens new avenues for pre-hospital stroke diagnosis, treatment and patient triage. The effects of STEMO care are planned to be assessed by the parallel B-PROUD-Study (NCT02869386).
- Purpose The B-SPATIAL-Registry will provide a tool of quality assessment for new specific treatments. It will also enable the participating hospitals to compare the quality of care of their own facility. Because this registry represents an quality monitoring initiative, the telephone follow-up is collected with an opt-out solution, allowing to decline participation after the patients are informed on the follow-up telephone call at discharge and through a letter send one month prior to the actual call. As written informed consent is not required, this method will facilitate a high follow-up rate particularly in patients with severe neurological deficits or treated in non-academic hospitals. In B-SPATIAL we want to identify key quality indicators that assure valid quality assessment despite reduced documentation load in future quality management. Specific Aims of the registry:
- Assessment of proportions of patients receiving specific treatments (based on total number of eligible)
- Evaluation of treatment specific indicators for process quality including pre-hospital care
- Evaluation of outcome quality (survival, level of disability and quality of life after 3 months) Pre-specified analyses: Ischemic stroke
- Intravenous hospital based tPA rate in treatment candidates
- Time to treatment in intravenous tPA
- Rate of secondary interhospital referral
- Proportions of patients receiving endovascular thrombectomy
- Time to groin puncture and reperfusion in patients with endovascular thrombectomy
- Proportions of used devices
- Proportions of patients with general/non general anesthesia (conscious sedation)
- Secondary intracranial hemorrhage
- Functional outcome according to mRS at 3 months Hemorrhagic stroke
- Time to start of intravenous antihypertensive treatment
- Time to start of PCC in patients with OAC or specific reversal of NOACs
- Rate of surgical treatments
- Rate of secondary interhospital referral
- Enlargement and final volume of ICH
- Functional outcome according to mRS at 3 months Data sources The documentation will include pre-hospital, in-hospital and post-discharge processes such as:
- Emergency medical service (EMS)
- Acute in-hospital stay
- Follow-up (first choice: telephone, second choice: written questionnaire, third choice: FU regarding vital status from registration offices)
- Patients In order to ensure valid analysis of treatment rates in participating hospitals, patients will be included according to the following inclusion criteria:
- Patients with hospital main discharge diagnoses according to ICD 10: Ischemic stroke (I63) or TIA (G45.0-G45.3 and G45.5-G45.9, respectively) and
- Onset of symptoms within 6 hours of hospital arrival
- In patients with TIA diagnosis: Persistent neurological symptoms at hospital arrival (emergency department documentation)
- Patients with main discharge diagnosis of intracranial hemorrhage and hospital admission within 6 hours of stroke onset.
- Patients with other main discharge diagnoses and documented intravenous thrombolysis (OPS 8-020.8) in order to monitor the treatment rate of stroke mimics
- Data documentation
- Data will be entered in all participating hospitals via remote access to the databank
- Data will be entered with pseudonyms but identification will only be possible in local hospitals via register-logs that will be safely stored in the hospitals.
- Databank characteristics
- For data entry, we will use the REDcap databank software with access from all participating hospitals.
- Dedicated computers will be used and safely stored in participating hospitals. Encryption and password algorithms will protect the remote access to the databank.
- The registry databank will be stored and hosted on a protected server of the Charité IT department.
- For statistical evaluation, the REDcap databank will be exported in an SPSS-based data format, stored on the server of the Center for Stroke Research Berlin (CSB).
- Responsibilities
- Data entry: Study nurses in participating hospitals
- Databank in Charité IT-center: Charité IT department and databank manager of the Clinical Research Units
- Scientific evaluation: PI of CSB (Jessica L.Rohmann in cooperation with Heinrich J. Audebert, Martin Ebinger and Christian Nolte)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stroke patients (ischemic and haemorrhagic)
Key inclusion criteria (5 listed)
- Patients with hospital main discharge diagnoses according to ICD 10: Ischemic stroke (I63) or TIA (G45.0-G45.3 and G45.5-G45.9, respectively) and
- Patients with main discharge diagnosis of intracranial hemorrhage and symptom onset within 6 hours of hospital admission
- Patients with other main discharge diagnoses and documented intravenous thrombolysis (OPS 8-020.8) in order to monitor the treatment rate of stroke mimics
Key exclusion criteria (2 listed)
- Symptom remission before EMS arrival or hospital arrival (if no EMS Transport)
- Primary subarachnoid hemorrhage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Modified Rankin Scale
Time frame: 3 months
Assessment of functional outcome over the entire range of the modified Rankin Scale
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 13 Sep 2022.
- 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 22223240Krebes S, Ebinger M, Baumann AM, Kellner PA, Rozanski M, Doepp F, Sobesky J, Gensecke T, Leidel BA, Malzahn U, Wellwood I, Heuschmann PU, Audebert HJ. Development and validation of a dispatcher identification algorithm for stroke emergencies. Stroke. 2012 Mar;43(3):776-81. doi: 10.1161/STROKEAHA.111.634980. Epub 2012 Jan 5.
- Background: PubMed 25490196Ebinger M, Fiebach JB, Audebert HJ. Mobile computed tomography: prehospital diagnosis and treatment of stroke. Curr Opin Neurol. 2015 Feb;28(1):4-9. doi: 10.1097/WCO.0000000000000165.
- Background: PubMed 25634000Wendt M, Ebinger M, Kunz A, Rozanski M, Waldschmidt C, Weber JE, Winter B, Koch PM, Freitag E, Reich J, Schremmer D, Audebert HJ; STEMO Consortium. Improved prehospital triage of patients with stroke in a specialized stroke ambulance: results of the pre-hospital acute neurological therapy and optimization of medical care in stroke study. Stroke. 2015 Mar;46(3):740-5. doi: 10.1161/STROKEAHA.114.008159. Epub 2015 Jan 29.
- 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 37021164Rohmann JL, Huerta-Gutierrez R, Audebert HJ, Kurth T, Piccininni M. Adjusted horizontal stacked bar graphs ("Grotta bars") for consistent presentation of observational stroke study results. Eur Stroke J. 2023 Mar;8(1):370-379. doi: 10.1177/23969873221149464. Epub 2023 Jan 13.
- Individual participant dataSharing planned: No
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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.
Jessica L Rohmann principal investigator
Center for Stroke Research 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 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 13 Sep 2022. 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 (time frame: 3 months). 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 NCT03027453, which also lists 6 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 13 Sep 2022.