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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03246256

Enrollment

260

Registered

2017-08-11

Start date

2016-12-21

Completion date

2021-06-30

Last updated

2020-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

acute, informed consent, thrombolysis

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 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).

Interventions

OTHERGroup 1

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026