Condition category
Circulatory System
Date applied
12/02/2017
Date assigned
18/03/2017
Last edited
14/03/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
A stroke is a serious medical condition that occurs when the blood supply to part of the brain is cut off. Stroke is a major healthcare issue worldwide. Mortality (death rate) from stroke has declined over time, but stroke is still responsible for one of every twenty deaths in the United States. Patients with severe stroke may need treatment in an intensive care unit (ICU). The long-term consequences of stroke have been investigated thoroughly, but much less is known about those patients who need to be admitted to the ICU. The aim of this study is to find the clinical parameters, measured when these stroke patients are admitted to an ICU, that can predict the patient’s long-term survival as well as their capacity to function in daily life after their illness.

Who can participate?
Stroke patients aged 18 or older, admitted via the Emergency Department (ED) to either the general or neurosurgical ICU of one of the University College London Hospitals (UCLH) in North Central London between February 2010 and May 2012

What does the study involve?
Participants are monitored for 4-6 years to see if they are still alive and if not, when they died. The participant’s capacity to function in daily life is also recorded. These values are measured at two moments: when the patient leaves the hospital and after one year at their follow-up check appointment. These data are used to find out which clinical parameters predict whether patients are likely to survive a stroke, their ability to function in daily life one year after their illness, and how they progress in this ability during the first year.

What are the possible benefits and risks of participating?
There are no direct benefits and risks to participants because this study only uses patient data obtained from databases. Future stroke patients could benefit from this study, because the results may help identify critical stroke patients who are at increased risk of death or poor functional outcome.

Where is the study run from?
University College London Hospitals NHS Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
February 2010 to February 2016

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
1. Miss Mariel van Valburg (scientific)
2. Dr Bart Geerts (scientific)

Trial website

Contact information

Type

Scientific

Primary contact

Miss Mariel van Valburg

ORCID ID

http://orcid.org/0000-0003-1242-994X

Contact details

Department of Anaesthesiology
University Medical Centre Utrecht
PO Box 85500
Mail stop Q.04.2.313
Utrecht
3508 GA
Netherlands

Type

Scientific

Additional contact

Dr Bart Geerts

ORCID ID

Contact details

Department of Anaesthesiology
Academic Medical Centre Amsterdam
Meibergdreef 9
Amsterdam
1015 AZ
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Retrospective UCLH Stroke Intensive care audit

Study information

Scientific title

Clinical predictors of short-term and long-term survival and functional outcome of ICU-admitted stroke patients

Acronym

Study hypothesis

This long-term follow-up study is conducted to determine the predictive value of common-used clinical parameters upon ICU admission for long-term all-cause mortality and functional outcome of adult ischaemic and intracerebral haemorrhagic stroke patients admitted to the ICU.

Ethics approval

Demographic and clinical data were obtained as part of an audit of standard care. All data were only acquired from the national, trust and hospital databases. Therefore all authors can confirm that ethics approval was not needed for this study.

Study design

Single-centre retrospective observational cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Other

Patient information sheet

No participant information sheet available

Condition

Stroke; ischaemic and intracerebral haemorrhagic cerebrovascular accident (CVA)

Intervention

Demographic and clinical data were obtained from the national, trust and hospital databases. Patients were selected if they were admitted to one of our four ICUs between February 2010 and May 2012 with a clinical diagnosis of acute ischaemic or intracerebral haemorrhagic stroke. Surviving patients were censored on February 20, 2016.

Prognostic factors for long-term all-cause post-stroke mortality will be determined by univariable and multivariable Cox proportional hazards regression analysis with log minus log plots to confirm proportionality of hazards assumption over time. Prognostic factors for good functional outcome and improved functional status will be determined with binary logistic regression.

Model development will be performed on a multiple imputed dataset with variable exclusion in a backward stepwise selection procedure set to the lowest p value in the model.

Intervention type

Other

Phase

Drug names

Primary outcome measures

All-cause mortality after ischaemic or intracerebral haemorrhagic stroke. The follow-up timepoints lie between 4 and 6 years (depending on when the patient suffered a critical stroke) or on the moment the patient died.

Secondary outcome measures

Functional outcome, measured using the modified Rankin scale at hospital discharge and at one year follow-up check appointment and recorded by the patient’s primary treating physician. The original data using this ordinal scale will be dichotomised for analysis. Good functional outcome is defined as independent functional status (mRS 0-2) versus poor functional outcome, defined as dependent functional status or dead (mRS 3-6). Furthermore, transition in mRS will be taken into account, defined as improved functional status (mRS even or increased between discharge and after one year) versus declined functional status (mRS decreased between discharge and after one year).

Overall trial start date

01/02/2010

Overall trial end date

20/02/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adult patients (aged 18 years or older) admitted via the Emergency Department (ED) to either the general or neurosurgical ICU of one of the University College London Hospitals (UCLH) in North Central London between February 2010 and May 2012
2. Clinical diagnosis of acute ischaemic or intracerebral haemorrhagic stroke, confirmed by non-contrast cranial CT scan

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. Patients with a subarachnoid or subdural bleeding
2. Patients with a known intra-cerebral or intracerebellar tumour
3. Patients who suffered an in-hospital stroke
4. Patients who were referred from another ICU for the same diagnosis

Recruitment start date

01/02/2010

Recruitment end date

31/05/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University College London Hospitals NHS Foundation Trust
235 Euston Road
London
NW1 2BU
United Kingdom

Sponsor information

Organisation

University College London Hospital NHS Foundation Trust

Sponsor details

235 Euston Road
London
NW1 2BU
United Kingdom

Sponsor type

Hospital/treatment centre

Website

https://www.uclh.nhs.uk/Pages/Home.aspx

Funders

Funder type

Hospital/treatment centre

Funder name

University College London Hospital NHS Foundation Trust

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal aiming within the first half year of 2017.

IPD sharing plan
The datasets generated during and/or analysed during the current study are/will be available upon request from Miss Mariel van Valburg.

Intention to publish date

01/05/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes