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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03246256
• Other study ID #: EA4/140/16
• Status: Active, not recruiting
• Start date: December 21, 2016
• Est. completion date: June 2021

Study information

• Verified date: November 2020
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 260
• Est. completion date: June 2021
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Group 1

Locations

Country	Name	City	State
Germany	Universitätsklinikum Frankfurt	Frankfurt am Main
Germany	Department of Neurology, University of Heidelberg	Heidelberg
Germany	Department of Neurology, University Hospital Leipzig	Leipzig	Saxonia
Germany	Klinikum der Stadt Ludwigshafen a. Rh.	Ludwigshafen am Rhein
Germany	Department of Neurology, University Hospital Würzburg	Würzburg	Bavaria

Sponsors (3)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Department of Cardiology and Pneumology, Charité, Campus Benjamin Franklin, Department of Neurology, Charité - Universitätsmedizin Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recall of the designated facts given during informed consent procedure on intravenous thrombolysis after acute ischaemic stroke		Within 24 hours