NCT03930719: PSD Screen

Post-stroke Delirium Screening

Completed Last updated 4 June 2020

What this trial tests

trial testing Stroke screening tools in Delirium in 141 participants. Completed in 31 August 2019.

Timeline

22 April 2019

Primary endpoint
21 July 2019

31 August 2019

Quick facts

Lead sponsor	University Medicine Greifswald
Status	Completed
Study type	OBSERVATIONAL
Enrollment	141
Start date	22 April 2019
Primary completion	21 July 2019
Estimated completion	31 August 2019
Sites	1 location across Germany

Drugs / interventions tested

• Stroke screening tools

Conditions studied

• Delirium — all drugs for Delirium →
• Ischemic Stroke — all drugs for Ischemic Stroke →
• Transient Ischemic Attack — all drugs for Transient Ischemic Attack →

Sponsor

University Medicine Greifswald

Who can join

Eligibility, any sex, with Delirium or Ischemic Stroke. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

For a long time, delirium was considered a merely temporary dysfunction of the brain. Today, it is established that it is a brain disease associated with network dysfunction, neuroinflammation and impaired transmitter homeostasis in a multicausal model. Following an episode of delirium, many patients do not return to their prior level of cognitive and functional performance. In particular, failed or delayed diagnosis with consecutive inadequate therapy contribute to the development of long-term cognitive decline that may ultimately lead to long-term care. Stroke patients are a particularly common delirium-affected population (10-46% depending on severity). Despite the frequency and clinical relevance of delirium in stroke patients, diagnostic characteristics of common screening methods are unknown. Similarly, the clinical phenotype and risk factors of patients who develop delirium have not been adequately described.

This study primarily aims to evaluate the diagnostic properties of established screening tools for delirium in a prospective cohort of well-characterised patients following ischemic cerebral events (either transient or manifest stroke). Secondary outcome criteria include predictors of post-stroke delirium (PSD) such as stroke location and size, pre-stroke cognitive functioning, ability to participate in daily routine activities and medical conditions.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Course and Recognition of Poststroke Delirium: A Prospective Noninferiority Trial of Delirium Screening Tools.
   Fleischmann R, Warwas S, Andrasch T, Kunz R, et al · · 2021 · cited 27× · PMID 33380165 · DOI 10.1161/strokeaha.120.031019
2. Predictors of post-stroke delirium incidence and duration: Results of a prospective observational study using high-frequency delirium screening.
   Fleischmann R, Andrasch T, Warwas S, Kunz R, et al · · 2023 · cited 14× · PMID 35722813 · DOI 10.1177/17474930221109353