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Information Recall on Informed Consent to Intravenous Thrombolysis in Patients With Acute Ischaemic Stroke.

NCT ID: NCT03246256

Last Updated: 2020-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

260 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-12-21

Study Completion Date

2021-06-30

Brief Summary

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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

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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 thrombolysis after the end of treatment. Patients with acute ischaemic stroke will be compared to a group of relatives who witnessed the informed consent procedure of a relative with acute ischaemic stroke, stroke patients who were not treated with intravenous thrombolysis and patients without an ischaemic stroke but similiar risk factors (admitted to the Departement of Cardiology and Pneumology, Charité, Campus Benjamin Franklin, Berlin, Germany).

Conditions

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Stroke

Keywords

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acute informed consent thrombolysis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Patients with acute ischaemic stroke who were administered intavenous thrombolysis or patients with acute ischaemic stroke refusing intravenous thrombolysis; recall in both cases 60 to 90 minutes after the informed consent procedure

Group 1

Intervention Type OTHER

Group 2

1st of 2nd degree relatives of patients with acute ischaemic stroke, who witnessed the informed consent procedure

Group 1

Intervention Type OTHER

Group 3

Stroke patients with acute or subacute ischaemic stroke with a contraindication for intravenous thrombolysis

Group 1

Intervention Type OTHER

Group 4

Patients without an ischaemic stroke but similiar risk factors (admitted to the Departement of Cardiology and Pneumology, Charité, Campus Benjamin Franklin, Berlin, Germany)

Group 1

Intervention Type OTHER

Group 5

Patients with acute ischaemic stroke who were administered intavenous thrombolysis - recall 24 hours after the informed consent procedure

Group 1

Intervention Type OTHER

Interventions

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Group 1

Intervention Type OTHER

Other Intervention Names

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Group 2 Group 3 Group 4 Group 5

Eligibility Criteria

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Inclusion Criteria

* age ≥18 years
* able to give informed consent
* ability to understand and read German
* no prior i.v.-thrombolysis


* suspected ischaemic stroke (according to brain CT) or MRI-proven acute ischaemic stroke
* indication for intravenous thrombolysis


· relative (1st or 2nd dregree) of a patient with acute ischaemic stroke and present during the informed consent procedure


* ischaemic stroke (according to brain MRI or CT)
* contraindication for intravenous thrombolysis


· present admission at the Department of Cardiology and Pneumology, Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin, Berlin, Germany

Exclusion Criteria

* not able to give imformed consent or under legal supervision/guardianship
* participation in an interventional study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Department of Neurology, Charité - Universitätsmedizin Berlin, Germany

UNKNOWN

Sponsor Role collaborator

Department of Cardiology and Pneumology, Charité, Campus Benjamin Franklin

UNKNOWN

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Karl Georg Haeusler

Consultant Neurologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Neurology, University Hospital Würzburg

Würzburg, Bavaria, Germany

Site Status

Department of Neurology, University Hospital Leipzig

Leipzig, Saxony, Germany

Site Status

Universitätsklinikum Frankfurt

Frankfurt am Main, , Germany

Site Status

Department of Neurology, University of Heidelberg

Heidelberg, , Germany

Site Status

Klinikum der Stadt Ludwigshafen a. Rh.

Ludwigshafen am Rhein, , Germany

Site Status

Countries

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Germany

References

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Schuster L, Essig F, Daneshkhah N, Herm J, Hellwig S, Endres M, Dirnagl U, Hoffmann F, Michalski D, Pfeilschifter W, Urbanek C, Petzold GC, Rizos T, Kraft A, Haeusler KG. Ability of patients with acute ischemic stroke to recall given information on intravenous thrombolysis: Results of a prospective multicenter study. Eur Stroke J. 2023 Mar;8(1):241-250. doi: 10.1177/23969873221143856. Epub 2023 Jan 6.

Reference Type DERIVED
PMID: 37021170 (View on PubMed)

Other Identifiers

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EA4/140/16

Identifier Type: -

Identifier Source: org_study_id