Status:
UNKNOWN
Information Recall on Informed Consent to Intravenous Thrombolysis in Patients With Acute Ischaemic Stroke.
Lead Sponsor:
Charite University, Berlin, Germany
Collaborating Sponsors:
Department of Neurology, Charité - Universitätsmedizin Berlin, Germany
Department of Cardiology and Pneumology, Charité, Campus Benjamin Franklin
Conditions:
Stroke
Eligibility:
All Genders
18+ years
Brief Summary
The aim of the study is to investigate the ability to recall information given during informed consent on intravenous thrombolysis in patients with acute ischaemic stroke.
Detailed Description
The purpose of this prospective multi-center study is to investigate whether patients with acute ischaemic stroke are able to recall information given before providing informed consent to intravenous ...
Eligibility Criteria
Inclusion
- Inclusion criteria (all):
- age ≥18 years
- able to give informed consent
- ability to understand and read German
- no prior i.v.-thrombolysis
- Additional inclusion criteria - patients with acute ischaemic stroke:
- suspected ischaemic stroke (according to brain CT) or MRI-proven acute ischaemic stroke
- indication for intravenous thrombolysis
- Additional inclusion criteria - relatives:
- · relative (1st or 2nd dregree) of a patient with acute ischaemic stroke and present during the informed consent procedure
- Additional inclusion criteria - stroke patients with a contraindication for thrombolysis:
- ischaemic stroke (according to brain MRI or CT)
- contraindication for intravenous thrombolysis
- Additional inclusion criteria - non-stroke patients:
- · present admission at the Department of Cardiology and Pneumology, Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin, Berlin, Germany
- Exclusion criteria (all groups):
- not able to give imformed consent or under legal supervision/guardianship
- participation in an interventional study
Exclusion
Key Trial Info
Start Date :
December 21 2016
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2021
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT03246256
Start Date
December 21 2016
End Date
June 1 2021
Last Update
November 13 2020
Active Locations (5)
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1
Department of Neurology, University Hospital Würzburg
Würzburg, Bavaria, Germany
2
Department of Neurology, University Hospital Leipzig
Leipzig, Saxony, Germany
3
Universitätsklinikum Frankfurt
Frankfurt am Main, Germany
4
Department of Neurology, University of Heidelberg
Heidelberg, Germany