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

November 10, 2020 updated by: Karl Georg Haeusler, Charite University, Berlin, Germany

Recall of Information on Intravenous Thrombolysis in Acute Ischaemic Stroke Patients Given During Informed Consent: a Prospective Observational Study.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 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).

Study Type

Observational

Enrollment (Anticipated)

260

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Frankfurt am Main, Germany
        • Universitatsklinikum Frankfurt
      • Heidelberg, Germany
        • Department of Neurology, University of Heidelberg
      • Ludwigshafen am Rhein, Germany
        • Klinikum der Stadt Ludwigshafen a. Rh.
    • Bavaria
      • Würzburg, Bavaria, Germany
        • Department of Neurology, University Hospital Würzburg
    • Saxonia
      • Leipzig, Saxonia, Germany
        • Department of Neurology, University Hospital Leipzig

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with acute ischaemic stroke and intravenous thrombolysis or patients with acute ischaemic stroke refusing intravenous thrombolysis, relatives (1st or 2nd degree) of patients with acute ischaemic stroke, patient with acute or subacute ischaemic stroke with a contraindication for intravenous thrombolysis and patients without acute ischaemic stroke (admitted to the Department of Cardiology (Charité, Campus Benjamin Franklin, Germany).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Other: Group 1
Other Names:
  • Group 2
  • Group 3
  • Group 4
  • Group 5
Group 2
1st of 2nd degree relatives of patients with acute ischaemic stroke, who witnessed the informed consent procedure
Other: Group 1
Other Names:
  • Group 2
  • Group 3
  • Group 4
  • Group 5
Group 3
Stroke patients with acute or subacute ischaemic stroke with a contraindication for intravenous thrombolysis
Other: Group 1
Other Names:
  • Group 2
  • Group 3
  • Group 4
  • Group 5
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)
Other: Group 1
Other Names:
  • Group 2
  • Group 3
  • Group 4
  • Group 5
Group 5
Patients with acute ischaemic stroke who were administered intavenous thrombolysis - recall 24 hours after the informed consent procedure
Other: Group 1
Other Names:
  • Group 2
  • Group 3
  • Group 4
  • Group 5

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Recall of the designated facts given during informed consent procedure on intravenous thrombolysis after acute ischaemic stroke
Time Frame: Within 24 hours
Within 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Collaborators

Department of Neurology, Charité - Universitätsmedizin Berlin, Germany
Department of Cardiology and Pneumology, Charité, Campus Benjamin Franklin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 21, 2016

Primary Completion (Actual)

June 1, 2020

Study Completion (Anticipated)

June 1, 2021

Study Registration Dates

First Submitted

August 3, 2017

First Submitted That Met QC Criteria

August 10, 2017

First Posted (Actual)

August 11, 2017

Study Record Updates

Last Update Posted (Actual)

November 13, 2020

Last Update Submitted That Met QC Criteria

November 10, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EA4/140/16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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