Berlin - SPecific Acute Treatment in Ischemic or hAemorrhagic Stroke With Long Term Follow-up

NCT03027453 | Completed

• 1 other identifier: B-SPATIAL
• Study Type: observational
• Target: 15,246
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• Modified Rankin Scale

  Assessment of functional outcome over the entire range of the modified Rankin Scale

  3 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Stroke patients (ischemic and haemorrhagic)

You may qualify if:

• 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
• Symptom remission before EMS arrival or hospital arrival (if no EMS Transport)
• Primary subarachnoid hemorrhage

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• Berliner Feuerwehr: collaborator
• Bundeswehrkrankenhaus Berlin: collaborator
• DRK-Kliniken Berlin Köpenick: collaborator
• Evangelisches Krankenhaus Königin Elisabeth Herzberge: collaborator
• Helios Klinikum Berlin-Buch: collaborator
• Jüdisches Krankenhaus Berlin: collaborator
• Park-Klinik Weissensee: collaborator
• Schlosspark-Klinik: collaborator
• Unfallkrankenhaus Berlin: collaborator
• Vivantes Auguste-Viktoria-Klinikum: collaborator
• Vivantes Klinikum im Friedrichshain: collaborator
• Vivantes Humboldt-Klinikum: collaborator
• Vivantes Clinic Neukölln: collaborator
• Vivantes Klinikum Spandau: collaborator

Study Sites (1)

Center for Stroke Research Berlin

Berlin, Germany

Location

Related Publications (6)

• 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: 24756512 BACKGROUND

• Krebes 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.

  PMID: 22223240 BACKGROUND

• Ebinger 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.

  PMID: 25490196 BACKGROUND

• Wendt 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.

  PMID: 25634000 BACKGROUND

• 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: 27430529 BACKGROUND

• Rohmann 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.

  PMID: 37021164 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jessica L Rohmann

  Center for Stroke Research 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: January 19, 2017
• First Posted: January 23, 2017
• Study Start: January 1, 2016
• Primary Completion: April 1, 2021
• Study Completion: December 1, 2021
• Last Updated: September 13, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)