Injury, inflammatory markers & the exacerbation of confusion: ASCRIBED

Plain English Summary

Background and study aims
Dementia is an umbrella term used to refer to a wide range of symptoms linked to with a reduction in memory and/or other thinking skills which reduce a person's ability to perform everyday activities. Inflammation is generally a beneficial response to tissue damage or infection. However, when inflammation is extensive or prolonged this can damage healthy tissues and disrupt normal cellular function. Research suggests that acute illnesses or injury causing inflammation can accelerate dementia. However there are few studies which examine underlying mechanisms of how this happens in humans. This study aims to address this gap. The study will compare markers of inflammation and injury found in the blood and cerebrospinal fluid (fluid which bathes the spinal cord (CSF)) of people with and without confirmed dementia who fracture their fracture. A hip fracture is a common example of an acute injury causing an inflammatory response. People who fracture their hip will undergo an operation to repair it. A common procedure during this operation is the giving of spinal aesthetic. This involves inserting a needle into the patient’s spinal space and injecting anaesthesia into CSF. This means CSF can be collected before operation via the same needle.

Who can participate?
Patients due to have a hip fracture operation via spinal anaesthesia with all levels of pre-operative confusion.

What does the study involve?
Patients are allocated to one of three groups after their operation: those with confirmed dementia (as obtained from patient’s GP notes/hospital records and/or carer insight), non-dementia (no evidence of dementia found in patent’s GP notes/medical records) groupings; and pre-operatively confused but without confirmed dementia. Consent is gained for the storage of surplus samples in a bio-bank to help future studies. Pre-operative blood and CSF samples, post-operative blood samples and a short cognitive questionnaire is administered to all patients.

What are the possible benefits and risks of participating?
For patients and their families there are no direct benefits taking part. However it is hoped that the research may help similar patient groups in the future. Postdural-puncture headaches (PDPH) are a common side-effect of spinal anaesthesia. The collection of CSF may slightly increase the chance of PDPH.

Where is the study run from?
This study is being run by University of East Anglia (UK) and takes place in hospitals in the UK.

When is the study starting and how long is it expected to run for?
November 2016 to December 2022

Who is funding the study?
Alzheimer’s Research UK (UK)

Who is the main contact?
Dr Simon Hammond
s.hammond@uea.ac.uk

Contact information

Dr Simon Hammond
Public

Norwich Medical School
University of East Anglia
Norwich Research Park
Norwich
NR4 7TJ
United Kingdom

ORCID ID	0000-0002-0473-3610
Phone	+44 1603 591460
Email	s.hammond@uea.ac.uk

Study information

Eligibility

Locations

Countries of recruitment

• England
• Scotland
• United Kingdom

Study participating centres

Sponsor information

University of East Anglia
University/education

University of East Anglia
Norwich Research Park
Norwich.
NR4 7TJ
England
United Kingdom

Phone	+44 1603 591460
Email	t.moulton@uea.ac.uk
"ROR"	https://ror.org/026k5mg93

Funders

Funder type

Charity

Results and Publications

Study outputs

Editorial Notes

03/10/2023: A contact was removed.
06/10/2022: The following changes were made to the trial record:
1. The overall end date was changed from 31/12/2021 to 31/12/2022.
2. The intention to publish date was changed from 30/04/2022 to 30/04/2023.
3. The plain English summary was updated to reflect these changes.
03/09/2021: The following changes were made to the trial record:
1. The overall trial end date was changed from 30/09/2021 to 31/12/2021.
2. The intention to publish date was changed from 30/04/2021 to 30/04/2022.
09/04/2021: The overall trial end date has been changed from 31/12/2019 to 30/09/2021 and the plain English summary has been updated accordingly.
09/12/2020: Publication reference added.
09/09/2020: The intention to publish date has been changed from 01/03/2020 to 30/04/2021.
09/09/2019: Total final enrolment number added.
17/09/2018: The intention to publish date has been changed from 01/11/2019 to 01/03/2020.
31/08/2018: The following changes have been made:
1. Gregory Howard has been added as a public contact.
2. The recruitment end date has been changed from 31/10/2018 to 31/08/2019.
3. The overall trial end date has been changed from 01/11/2018 to 31/12/2019.
4. Southend University Hospital NHS Foundation Trust, The Ipswich Hospital NHS Trust and The Princess Alexandra Hospital NHS Trust have been removed from the trial centres. Basildon University Hospital, Musgrove Park Hospital, Scunthorpe General Hospital, Royal Lancaster Infirmary, Yeovil District Hospital, Watford General Hospital and Sandwell General Hospital have been added to the trial centres.
28/03/2018: Ethics approval details were added.
26/03/2018: The following changes were made:
1. Recruitment end date was changed from 28/02/2018 to 31/10/2018
2. Overall trial end date was changed from 31/08/2018 to 01/11/2018.
3. Intention to publish date was changed from 28/02/2019 to 01/11/2019.
22/02/2018: The plain English summary has been updated to reflect the updates in the study record.
20/02/2018: The overall trial end date has been updated from 28/02/2018 to 31/08/2018. The following sites were added: Pinderfields Hospital, Mid Yorkshire Hospitals NHS Trust, York Teaching Hospital NHS Foundation Trust, Princess Royal Hospital, Brighton & Sussex University Hospitals NHS Trust, James Paget University Hospital, Russells Hall Hospital, The Dudley Group NHS Foundation Trust, Peterborough City Hospital, North West Anglia NHS Foundation Trust, Queen’s Medical Centre Campus, Nottingham University Hospitals NHS Trust, Royal Blackburn Hospital, East Lancashire Hospitals NHS Trust, University Hospital of North Tees, North Tees and Hartlepool NHS Foundation Trust, The Royal Shrewsbury Hospital, The Shrewsbury and Telford Hospital NHS Trust, Doncaster Royal Infirmary, Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust, Royal United Hospital Bath NHS Foundation Trust, University Hospital of North Durham, County Durham and Darlington NHS Foundation Trust, Royal Bolton Hospital, Bolton NHS Foundation Trust, Kingston Hospital, Kingston Hospital NHS Foundation Trust, Royal Stoke University Hospital, University Hospitals of North Midlands NHS Trust, Countess of Chester Hospital NHS Foundation Trust, Western Sussex Hospitals NHS Foundation Trust, Medway Maritime Hospital, Medway NHS Foundation Trust, Whiston Hospital, St Helens & Knowsley Teaching Hospitals NHS Trust, Southampton General Hospital, University Hospital Southampton NHS Foundation Trust, Royal Devon & Exeter Hospital (Wonford), Royal Devon and Exeter NHS Foundation Trust, Southend University Hospital NHS Foundation Trust, The Ipswich Hospital NHS Trust, and The Princess Alexandra Hospital NHS Trust
23/10/2017: Internal review.