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Targeted Metabolic Profiling in Deep Vein Thrombosis

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 evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04096755
Recruitment Status : Not yet recruiting
First Posted : September 20, 2019
Last Update Posted : September 20, 2019
Sponsor:
Information provided by (Responsible Party):
Imperial College London

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.


Condition or disease Intervention/treatment
Deep Vein Thrombosis Diagnostic Test: Procedure

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Targeted Metabolic Profiling in Deep Vein Thrombosis
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : October 1, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
serum and urine samples will be taken for analysis

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
serum and urine samples will be taken for analysis




Primary Outcome Measures :
  1. Identification of diagnostic deep vein thrombosis metabolites [ Time Frame: 24 months ]
    We are looking for a unique metabolic signature (a change in the concentration of two or more metabolites) in patients with deep vein thrombosis


Secondary Outcome Measures :
  1. To validate previously identified molecules/chemicals that were found to differ in the DVT population in comparison to the non DVT controls [ Time Frame: 24 months ]
  2. To establish the concentration of the identified molecules in DVT patients and controls [ Time Frame: 24 months ]
  3. Correlation of identified metabolite concentrations to known DVT biomarkers (e.g. D dimer) [ Time Frame: 24 months ]

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)


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
All study participants will be over the age of 18 and have capacity to consent.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04096755


Contacts
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Contact: kemal kemal, MBBS 07535632123 ext 07535632123 k.kemal@imperial.ac.uk
Contact: Alun Davies, BM BCh (Oxon) 02033117320 a.h.davies@imperial.ac.uk

Locations
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United Kingdom
Imperial College London, Academic Section of vascular Surgery, 4th floor East Wing, Charing Cross Hospital
London, United Kingdom, W6 8RF
Contact: Kemal kemal, MBBS    07535632123 ext 07535632123    k.kemal@imperial.ac.uk   
Contact: Alun C Davies, BM BCh (Oxon    02033117320 ext 07535632123    a.h.davies@imperial.ac.uk   
Principal Investigator: Professor Alun Davies, BM BCh (Oxon)         
Sub-Investigator: kemal kemal, MBBS         
Sponsors and Collaborators
Imperial College London
Investigators
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Principal Investigator: Alun Davies Imperial College London
  Study Documents (Full-Text)

Documents provided by Imperial College London:
Informed Consent Form  [PDF] November 11, 2018

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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT04096755    
Other Study ID Numbers: 245270
First Posted: September 20, 2019    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Imperial College London:
Deep Vein Thrombosis
Additional relevant MeSH terms:
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Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases