Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12625000541404
Ethics application status
Approved
Date submitted
8/05/2025
Date registered
28/05/2025
Date last updated
28/05/2025
Date data sharing statement initially provided
28/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Developing a Novel Algorithm to Exclude Deep Vein Thrombosis in the Emergency Department
Scientific title
Developing a Novel Algorithm to Exclude Deep Vein Thrombosis in the Emergency Department
Secondary ID [1] 314232 0
Nil known
Universal Trial Number (UTN)
Trial acronym
DNA-DVT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
deep vein thrombosis 337138 0
Condition category
Condition code
Blood 333561 333561 0 0
Clotting disorders
Cardiovascular 333894 333894 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
A retrospective cohort study (up to 4 years of Emergency Department (ED) presentations) reviewing historical risk factors, examination findings and d dimer levels and the ability to combine these into a simple score to accurately exclude the diagnosis of deep vein thrombosis (DVT)

Data will be reviewed from electronic medical records for patients presenting to the Emergency Departments at Royal North Shore Hospital and Hornsby Kuringgai Hospital between 1 January 2021 and 31 December 2024. Records will be assessed during a single presentation and it will be noted if the patient has re-presented within the following 14 days. A review of medical records for history and examination findings as well as investigation results of D dimer blood results and Vascular US imaging reports will be collected.

The novel algorithm will be developed using statistical analysis (both regression analysis and bootstrapping) to determine a combination of risk factors that are sufficiently sensitive to exclude DVT.
Intervention code [1] 330843 0
Early Detection / Screening
Comparator / control treatment
No control group.
Will compare the algorithm with previous reported diagnostic tools including Well's Criteria for DVT, the Primary Care Rule, the DAYS Algorithm (by Xu et al. (2021); not an acronym) and Halestensen et al. (2024) Rule
Control group
Active

Outcomes
Primary outcome [1] 341139 0
Incidence of DVT diagnosis
Timepoint [1] 341139 0
Baseline
Secondary outcome [1] 446479 0
Frequency of DVT risk factors in pregnant patients
Timepoint [1] 446479 0
Baseline
Secondary outcome [2] 447885 0
Frequency of unnecessary investigations
Timepoint [2] 447885 0
baseline
Secondary outcome [3] 447886 0
Sensitivity and specificity of novel algorithm compared to previous algorithms and will be assessed together as a composite secondary outcome
Timepoint [3] 447886 0
baseline

Eligibility
Key inclusion criteria
Adult patients
Presented to Royal North Shore Hospital or Hornsby Kuringgai Hospital Emergency Department with a suspected DVT
Underwent both D dimer and Vascular ultrasound within 36 hours
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who have not undergone both D dimer and lower limb ultrasound testing
Patients presenting with another primary concern, for example chest pain or dyspnoea

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Convenience sample
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/06/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 27893 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [2] 27894 0
Hornsby Ku-ring-gai Hospital - Hornsby
Recruitment postcode(s) [1] 44089 0
2065 - St Leonards
Recruitment postcode(s) [2] 44090 0
2077 - Hornsby

Funding & Sponsors
Funding source category [1] 318751 0
Hospital
Name [1] 318751 0
Royal North Shore Hospital
Country [1] 318751 0
Australia
Primary sponsor type
Government body
Name
Northern Sydney Local Health District
Address
Country
Australia
Secondary sponsor category [1] 321191 0
None
Name [1] 321191 0
Address [1] 321191 0
Country [1] 321191 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317363 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 317363 0
Ethics committee country [1] 317363 0
Australia
Date submitted for ethics approval [1] 317363 0
17/04/2025
Approval date [1] 317363 0
19/05/2025
Ethics approval number [1] 317363 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 140810 0
Dr Benjamin Needham
Address 140810 0
Royal North Shore Hospital, Reserve Road, St Leonards NSW 2065
Country 140810 0
Australia
Phone 140810 0
+61 294632256
Fax 140810 0
Email 140810 0
[email protected]
Contact person for public queries
Name 140811 0
Mark Gillett
Address 140811 0
Royal North Shore Hospital, Reserve Road, St Leonards NSW 2065
Country 140811 0
Australia
Phone 140811 0
+61 294632228
Fax 140811 0
Email 140811 0
[email protected]
Contact person for scientific queries
Name 140812 0
Mark Gillett
Address 140812 0
Royal North Shore Hospital, Reserve Road, St Leonards NSW 2065
Country 140812 0
Australia
Phone 140812 0
+61 294632228
Fax 140812 0
Email 140812 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Studies testing whether findings can be repeated or confirmed
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?
Yes: will need discussion with data custodian and local ethics committee



What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Study protocol    UTF-8Study Protocol v1.4.docx


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.