Destiny: D-dimer. Investigating D-dimer Levels Using Point-of-Care (POC) Testing at Primary Care.

NCT05109260 | Unknown

• 1 other identifier: 285916
• Study Type: observational
• Target: 244
• Locations: 1 country
• Sites: 2

Brief Summary

DESTINY D-Dimer is an observational feasibility study, and a collaboration between the University of South Wales and Cwm Taf Morgannwg University Health Board (CTMUHB). The study is based at St. John's Medical Practice in Aberdare, where participant recruitment will take place. Blood D-dimer data will be collected from CTMUHB Pathology Laboratory services, at Prince Charles Hospital. Study blood samples will be obtained by the research student, LAH, under the direction of Dr Owen Thomas at St John's Medical Centre. The participant data will be collected by the research student who will conduct a Wells' Risk Score and perform D-dimer POC tests to generate quantitative data. Data will later be compared by the research student with the diagnoses obtained from Secondary Care at Prince Charles Hospital via analysis of medical records to include a laboratory generated D-Dimer results and additional diagnostics (eg. Doppler). A laboratory based analytical verification of D-dimer POC tests will be undertaken to compare with the current laboratory method. The study will compare the data from the D-dimer POC tests and those gained using laboratory methods at Prince Charles Hospital.

Conditions

Deep Vein Thrombosis

Outcome Measures

Primary Outcomes (1)

• D-dimer levels

  D-dimer levels in blood will be compared across devices and to standalone testing currently in practice at Secondary Care facilities.

  10 months

Secondary Outcomes (1)

• Well's Risk Score

  10 months

Interventions

Point-of-Care Immunoassay device DIAGNOSTIC_TEST

2 POC Immunoassay devices will be used. One will measure D-dimer levels in capillary blood, the other will measure venous.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be recruited from patients attending t St. Johns Medical Centre and Ysbyty Cwm Rhondda that are suspected of having a thrombosis upon assessment. There is scope to widen recruitment from neighbouring cluster practices. The study aims to collect a minimum of 244 patients for the study to achieve 80% power.

You may qualify if:

• Subject \>18 years of age.
• Initial assessment of thrombosis.
• Consent provided.
• Patient declared healthy and suitable for participation by PI.
• Suitable venous access.

You may not qualify if:

• Unable to provide informed consent.
• Pregnancy.
• Undergoing end of life care.
• The subject is currently receiving or has received within the past thirty days of the study visit an experimental biologic or drug including either treatment or therapy
• Haemodynamically unstable.
• Current anticoagulation therapy.
• Flu symptoms acknowledged by the PI.
• Positive Covid-19 test result.

Sponsors & Collaborators

• University of South Wales: lead

Study Sites (2)

St John's Medical Centre

Aberdare, Rhondda Cynon Taff, United Kingdom

RECRUITING

Ysbyty Cwm Rhondda Urgent Care Centre

Llwynypia, Rhondda Cynon Taff, United Kingdom

RECRUITING

MeSH Terms

Conditions

Venous Thrombosis

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Mark Williams, BSc, PhD

  Director of Studies and Chief investigator

  STUDY DIRECTOR

Central Study Contacts

Leon Arrowsmith-Hill, BSc

CONTACT

07568086924; leon.arrowsmith-hill@southwales.ac.uk

Mark Williams, BSc, PhD

CONTACT

02920498700; Mark.williams@southwales.ac.uk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2021
• First Posted: November 5, 2021
• Study Start: October 26, 2021
• Primary Completion: September 1, 2022
• Study Completion: March 1, 2023
• Last Updated: November 5, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)