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Berlin - SPecific Acute Treatment in Ischemic or hAemorrhagic Stroke With Long Term Follow-up (B-SPATIAL)

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ClinicalTrials.gov Identifier: NCT03027453
Recruitment Status : Recruiting
First Posted : January 23, 2017
Last Update Posted : February 27, 2018
Sponsor:
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 Klinikum Neukölln
Vivantes Klinikum Spandau
Information provided by (Responsible Party):
Heinrich J Audebert, Charite University, Berlin, Germany

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.

Condition or disease
Stroke

  Show Detailed Description

Study Type : Observational [Patient Registry]
Estimated Enrollment : 9000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: Berlin - Specific Acute Treatment in Ischemic or Haemorrhagic Stroke With Long Term Follow-up
Study Start Date : January 2016
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019



Primary Outcome Measures :
  1. Modified Rankin Scale [ Time Frame: 3 months ]
    Assessment of functional outcome over the entire range of the modified Rankin Scale



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Stroke patients (ischemic and haemorrhagic)
Criteria

Inclusion criteria:

  1. 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)
  2. Patients with main discharge diagnosis of intracranial hemorrhage and symptom onset within 6 hours of hospital admission
  3. Patients with other main discharge diagnoses and documented intravenous thrombolysis (OPS 8-020.8) in order to monitor the treatment rate of stroke mimics

Exclusion Critera:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03027453


Contacts
Contact: Heinrich J Audebert, MD +49308445 ext 2276 heinrich.audebert@charite.de
Contact: Martin Ebinger, MD +4930 300240 ext 0 M.Ebinger@medicalpark.de

Locations
Germany
Center for Stroke Research Berlin Recruiting
Berlin, Germany
Contact: Bob Siegerink    +4930450 560 ext 621    bob.siegerink@charite.de   
Sponsors and Collaborators
Charite University, Berlin, Germany
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 Klinikum Neukölln
Vivantes Klinikum Spandau
Investigators
Principal Investigator: Bob Siegerink Center for Stroke Research Berlin

Publications:

Responsible Party: Heinrich J Audebert, Prof. Dr. med., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT03027453     History of Changes
Other Study ID Numbers: B-SPATIAL
First Posted: January 23, 2017    Key Record Dates
Last Update Posted: February 27, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases