Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000522314
Ethics application status
Approved
Date submitted
21/03/2017
Date registered
10/04/2017
Date last updated
14/02/2020
Date data sharing statement initially provided
14/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Frailty in patients undergoing major limb amputation for peripheral arterial disease
Scientific title
Frailty in patients undergoing major limb amputation for peripheral arterial disease: a retrospective cohort study
Secondary ID [1] 291489 0
None
Universal Trial Number (UTN)
U1111-1194-4554
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Frailty 302557 0
Condition category
Condition code
Cardiovascular 302089 302089 0 0
Diseases of the vasculature and circulation including the lymphatic system
Surgery 302228 302228 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The frailty characteristics of patients undergoing major lower limb amputation at one of the hospitals run by Aneurin Bevan University Health Board in South East Wales from January 2010 until January 2017 will be recorded to determine the effects of frailty on outcome, and compared to established risk prediction models. We will record basic demographics, comorbidity (in the form of the Charlson Comorbidity Index), functional status (Katz score), residential status, Waterlow score, pre-operative blood tests and ECG, and pre-operative haemodynamics (highest heart rate and lowest blood pressure on the day of surgery). The Addenbrookes Vascular Frailty Score will be calculated, along with generic models for outcome following amputation. In all cases, pre-operative values will be collected.
Intervention code [1] 297558 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 301527 0
All-cause mortality
Timepoint [1] 301527 0
12 months
Secondary outcome [1] 332927 0
Post-operative length of inpatient stay during index admission
Timepoint [1] 332927 0
This will be Censored at the end of the study for patients who are still inpatients
Secondary outcome [2] 332928 0
Re-admission to hospital following discharge
Timepoint [2] 332928 0
12 months
Secondary outcome [3] 332929 0
Discharge destination
Timepoint [3] 332929 0
Time of discharge
Secondary outcome [4] 333416 0
Successful mobilisation with prosthesis as assessed by review of medical and rehabilitation notes.
Timepoint [4] 333416 0
12 months

Eligibility
Key inclusion criteria
Patients undergoing lower limb amputation above the ankle at any hospital in South East Wales overseen by Aneurin Bevan University Health Board between January 2010 and January 2017
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients having amputation at or below the ankle.
Patients undergoing revision amputation which does not cross a major joint: for example a patient having revision of a below knee amputation to a shorter below knee amputation would be excluded, but a patient who has had a below knee amputation who has a revision to an above knee amputation need not be excluded.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
The Addenbrookes Vascular Frailty Score will be calculated, along with generic models for outcome following amputation. An amputation-specific frailty score will then be developed using stepwise logistic regression modelling, with mortality at 12 months as the primary outcome. Performance of the new tool will be compared to existing models.
Missing data is a common issue observational studies such as this one, so we will use multiple imputation methodology to account for missing data. During model generation, Information Criterion analysis will be used to select predictors. This will enable us to develop a parsimonious model which avoids over-fitting. Bootstrap methodology will then be used to assess performance of the model.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
18/04/2017
Actual
Date of last participant enrolment
Anticipated
28/06/2017
Actual
Date of last data collection
Anticipated
30/06/2017
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment outside Australia
Country [1] 8751 0
United Kingdom
State/province [1] 8751 0
South East Wales

Funding & Sponsors
Funding source category [1] 295969 0
Hospital
Name [1] 295969 0
Royal Gwent Hospital
Country [1] 295969 0
United Kingdom
Primary sponsor type
Government body
Name
Aneurin Bevan University Health Board
Address
Clinical Research and Innovation Centre
St Woolos Hospital
Block C
Stow Hill
Newport, South Wales
NP20 4SZ
Country
United Kingdom
Secondary sponsor category [1] 294862 0
Individual
Name [1] 294862 0
Christopher Twine
Address [1] 294862 0
Vascular Institute
Royal Gwent Hospital
Cardiff Road
Newport
NP20 2UB
Country [1] 294862 0
United Kingdom

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297240 0
Aneurin Bevan University Health Board Research Risk Review Committee
Ethics committee address [1] 297240 0
Ethics committee country [1] 297240 0
United Kingdom
Date submitted for ethics approval [1] 297240 0
10/02/2017
Approval date [1] 297240 0
15/02/2017
Ethics approval number [1] 297240 0
SA/736/17

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1594 1594 0 0
/AnzctrAttachments/372593-sa-736-17 approval letter.pdf (Ethics approval)
Attachments [2] 1600 1600 0 0
/AnzctrAttachments/372593-Frailty in amputation protocol.docx (Protocol)

Contacts
Principal investigator
Name 73430 0
Mr Christopher Twine
Address 73430 0
Vascular Institute
Royal Gwent Hospital
Cardiff Road
Newport
NP20 2UB
Country 73430 0
United Kingdom
Phone 73430 0
+44 1633 234234
Fax 73430 0
Email 73430 0
[email protected]
Contact person for public queries
Name 73431 0
Graeme Ambler
Address 73431 0
Vascular Institute
Royal Gwent Hospital
Cardiff Road
Newport
NP20 2UB
Country 73431 0
United Kingdom
Phone 73431 0
+44 1633 234234
Fax 73431 0
Email 73431 0
[email protected]
Contact person for scientific queries
Name 73432 0
Graeme Ambler
Address 73432 0
Vascular Institute
Royal Gwent Hospital
Cardiff Road
Newport
NP20 2UB
Country 73432 0
United Kingdom
Phone 73432 0
+44 1633 234234
Fax 73432 0
Email 73432 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.