Targeted Metabolic Profiling in Deep Vein Thrombosis

NCT04096755 | Unknown

• 1 other identifier: 245270
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Deep venous thrombosis(DVT) is a blood clot, usually affecting the legs, causing pain, swelling, and redness. The clot damages the veins, which can result in chronic pain, swelling and ulceration. This is called the post-thrombotic syndrome, which impacts heavily on patients' life and work. If the clot dislodges and travels to the lungs, it becomes a pulmonary embolus (PE), which can be life threatening. Together, DVT and PE affect 500,000 people in Europe every year, representing the most common cause of hospital acquired death. They are expensive diseases due to the cost of treatment and the days lost from people being unable to work. DVT is diagnosed by clinical examination, risk scoring and a blood test called D dimer, a product of the clot. If negative, it is unlikely that DVT is present. However, many conditions can raise D-dimer levels, making it less useful when positive. Ultrasound can confirm the presence of clot but often this is not seen. The clot can take time to form and patients may not experience symptoms immediately. This is a problem for treatment, as new, clot-busting medication works best in the first 2 weeks after a DVT and it is difficult to tell when the clot formed. Metabonomics is highly sensitive technology that detects very small chemicals; it is being used successfully in cancer and is a tool that can help better understand DVT and generate new tests to help patients. Previous departmental work has shown that a chemical difference exists in patients with DVT. The aim of this study is to not only confirm the presence of these chemicals in a different group of DVT patients, but also to calculate chemical concentrations. This will improve the investigator's understanding of how DVT develops and provide a way to develop a test that is better than D-dimer.

Conditions

Deep Vein Thrombosis

Keywords

Deep Vein Thrombosis

Outcome Measures

Primary Outcomes (1)

• Identification of diagnostic deep vein thrombosis metabolites

  We are looking for a unique metabolic signature (a change in the concentration of two or more metabolites) in patients with deep vein thrombosis

  24 months

Secondary Outcomes (3)

• To validate previously identified molecules/chemicals that were found to differ in the DVT population in comparison to the non DVT controls

  24 months

• To establish the concentration of the identified molecules in DVT patients and controls

  24 months

• Correlation of identified metabolite concentrations to known DVT biomarkers (e.g. D dimer)

  24 months

Study Arms (2)

DVT group

40 patients with a confirmed deep venous thrombosis (DVT) on Duplex ultrasound will be recruited into this group. All patients will have serum and urine samples for analysis.

Diagnostic Test: Procedure

Control Group

40 volunteers without a DVT will be recruited for the control group. They will have urine and serum samples taken for analysis.

Diagnostic Test: Procedure

Interventions

Procedure DIAGNOSTIC_TEST

serum and urine samples will be taken for analysis

Control Group; DVT group

Eligibility Criteria

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

Study Population

All study participants will be over the age of 18 and have capacity to consent.

You may qualify if:

• \>18 years of age
• Willing/able to give written informed consent
• Patients with DVT and age and sex matched controls confirmed on duplex ultrasound

You may not qualify if:

• Pregnancy (excluded based upon patient history, documented last menstrual period and urinary pregnancy test if patient unsure)
• Patients with blood borne disorders (HIV, Hepatitis B, C)
• Patients on systemic steroids and immunomodulating drugs
• Patients involved in a different venous research project or who have recently been involved with a venous research project

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Imperial College London, Academic Section of vascular Surgery, 4th floor East Wing, Charing Cross Hospital

London, W6 8RF, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Urine and serum samples will be obtained from participants for Nuclear Magnetic Resonance Spectroscopy and Mass Spectroscopy analysis. We will retain serum samples from the DVT patients for future DNA research (not part of this project)

MeSH Terms

Conditions

Venous Thrombosis

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Alun Davies

  Imperial College London

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 15, 2019
• First Posted: September 20, 2019
• Study Start: October 1, 2019
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)