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Be Part of Research - Trial Details - Reducing the rate of blood clots in patients undergoing varicose vein treatment

Reducing the rate of blood clots in patients undergoing varicose vein treatment

Medical Conditions

VTE prevention (in patients undergoing endovenous varicose vein interventions)


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Varicose veins are enlarged veins close to the surface of the skin. They are connected to the bigger deeper veins in the leg, known as deep veins. Endovenous interventions are keyhole operations for varicose veins that are carried out from within the vein itself. Because of this, operations to close the varicose veins can increase the chance of a blood clot forming in the deep veins. Blood clots in the deep veins happen in around 1 in 50 people after endovenous operations. A clot in the leg can cause swelling, pain, and other problems. If a clot in the leg travels to the lungs, it may be life-threatening. Medicines to reduce the blood's tendency to form clots are often prescribed to patients at high risk of blood clots. However, it is unclear if these clot-reducing medicines are beneficial in preventing blood clots in people having these varicose vein procedures. Elastic stockings that squeeze the leg and improve the blood flow through the veins are applied after the varicose vein procedure which helps to reduce the risk of blood clots. This study will investigate if it is worthwhile to prescribe medicines to reduce blood clots after varicose vein procedures. People enrolled in the study will undergo an assessment to make sure that they don’t have the most important risk factors for clots.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

15 Jan 2024 31 Mar 2026

Publications

2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/38367965/ (added 19/02/2024)

Participants will receive stockings along with, at random, one of the following three treatments:
1. No clot-reducing medicine, or
2. A single dose of clot-reducing medicine, or
3. An extended course (7-14 days) of clot-reducing medicine
Everyone in the study will get an ultrasound scan 21-28 days after their operation to check if they have not developed a blood clot. This scan is not routinely performed in the NHS and is an additional scan to ensure that all blood clots are detected early. Participants will also receive a phone call 7- and 90-days after their procedure to see if they have developed a blood clot or had any problems with the treatment.


Patients aged over 18 years scheduled to undergo endovenous treatment of varicose veins under local anaesthetic

You can take part if:



You may not be able to take part if:


Current exclusion criteria as of 06/03/2025:

1. Clinical indication for therapeutic anticoagulation e.g., atrial fibrillation 2. Previous personal or first-degree relative history of VTE 3. Thrombophilia 4. Female patients of childbearing potential who have a positive pregnancy test 5. A history of allergy to heparins or direct oral anticoagulants 6. A history of heparin-induced thrombocytopenia 7. Inherited and acquired bleeding disorders 8. Evidence of active bleeding 9. Concomitant major health problems such as active cancer and chronic renal and/or liver impairment 10. Known thrombocytopenia (platelets known to be less than 50 x 10^9/l) 11. Major trauma or non-venous surgery that required local risk assessment for VTE in the previous 90 days12. Recent ischemic stroke in the previous 90 days 13. Inability to provide consent

_____

Previous exclusion criteria as of 12/01/2024:

1. Clinical indication for therapeutic anticoagulation e.g., atrial fibrillation 2. Previous personal or first-degree relative history of VTE 3. Thrombophilia 4. Female patients of childbearing potential who have a positive pregnancy test 5. A history of allergy to heparins or direct oral anticoagulants 6. A history of heparin-induced thrombocytopenia 7. Inherited and acquired bleeding disorders 8. Evidence of active bleeding 9. Concomitant major health problems such as active cancer and chronic renal and/or liver impairment 10. Known thrombocytopenia (platelets known to be less than 50 x 10^9/l) 11. Surgery or major trauma in the previous 90 days 12. Recent ischemic stroke in the previous 90 days 13. Inability to provide consent

_____

Previous exclusion criteria:

1. Clinical indication for therapeutic anticoagulation 2. Clinical contraindication to anticoagulation3. Previous personal or family history of VTE4. Thrombophilia 5. Inability to provide informed consent or consent by personal/professional legal representative6. A positive test for SARS-CoV2 <3 months of procedure7. Female patients of childbearing age who have a positive pregnancy test


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Brighton and Sussex University Hospitals NHS Trust
    Royal Sussex County Hospital Eastern Road
    Brighton
    BN2 5BE
  • Nottingham University Hospitals NHS Trust
    Trust Headquarters Queens Medical Centre Derby Road
    Nottingham
    NG7 2UH
  • University Hospitals of North Midlands NHS Trust
    Newcastle Road
    Stoke-on-trent
    ST4 6QG
  • Cambridge University Hospitals NHS Foundation Trust
    Cambridge Biomedical Campus Hills Road
    Cambridge
    CB2 0QQ
  • Belfast Health and Social Care Trust
    Trust Headquarters A Floor - Belfast City Hospital Lisburn Road
    Belfast
    BT9 7AB
  • Leeds Teaching Hospitals NHS Trust
    St. James's University Hospital Beckett Street
    Leeds
    LS9 7TF
  • Cardiff & Vale University Lhb
    Woodland House Maes-y-coed Road
    Cardiff
    CF14 4HH
  • Manchester University NHS Foundation Trust
    Cobbett House Oxford Road
    Manchester
    M13 9WL
  • University Hospitals of Leicester NHS Trust
    Leicester Royal Infirmary Infirmary Square
    Leicester
    LE1 5WW
  • Northampton General Hospital NHS Trust
    Cliftonville
    Northampton
    NN1 5BD
  • Norfolk and Norwich University Hospitals NHS Foundation Trust
    Colney Lane Colney
    Norwich
    NR4 7UY
  • East Lancashire Hospitals NHS Trust
    Royal Blackburn Hospital Haslingden Road
    Blackburn
    BB2 3HH
  • University Hospitals Bristol and Weston NHS Foundation Trust
    Trust Headquarters Marlborough Street
    Bristol
    BS1 3NU
  • The Newcastle upon Tyne Hospitals NHS Foundation Trust
    Freeman Hospital Freeman Road High Heaton
    Newcastle upon Tyne
    NE7 7DN
  • Imperial College Healthcare NHS Trust
    The Bays St Marys Hospital South Wharf Road
    London
    W2 1BL
  • The Royal Wolverhampton NHS Trust
    New Cross Hospital Wolverhampton Road Heath Town
    Wolverhampton
    WV10 0QP
  • Liverpool University Hospitals NHS Foundation Trust
    Royal Liverpool University Hospital Prescot Street
    Liverpool
    L7 8XP
  • Oxford University Hospitals
    John Radcliffe Hospital Headley Way Headington
    Oxford
    OX3 9DU
  • Hull University Teaching Hospitals NHS Trust
    Hull Royal Infirmary Anlaby Road
    Hull
    HU3 2JZ
  • Aneurin Bevan University Health Board
    Lodge Road Caerleon
    Newport
    NP18 3XQ
  • Frimley Health NHS Foundation Trust
    Portsmouth Road Frimley
    Camberley
    GU16 7UJ
  • Worcestershire Acute Hospitals NHS Trust
    Worcestershire Royal Hospital Charles Hastings Way
    Worcester
    WR5 1DD
  • London North West University Healthcare NHS Trust
    Northwick Park Hospital Watford Road
    Harrow
    HA1 3UJ
  • East Kent Hospitals University NHS Foundation Trust
    Kent & Canterbury Hospital Ethelbert Road
    Canterbury
    CT1 3NG
  • Swansea Bay University Local Health Board
    One Talbot Gateway, Seaway Drive Seaway Parade Industrial Estate Baglan
    Port Talbot
    SA12 7BR
  • Cwm Taf Morgannwg University Local Health Board
    Dewi Sant Hospital Albert Road
    Pontypridd
    CF37 1LB
  • Mid and South Essex NHS Foundation Trust
    Prittlewell Chase
    Westcliff-on-sea
    SS0 0RY
  • York and Scarborough Teaching Hospitals NHS Foundation Trust
    York Hospital Wigginton Road
    York
    YO31 8HE
  • Somerset NHS Foundation Trust
    Trust Management Lydeard House Musgrove Park Hospital
    Taunton
    TA1 5DA
  • Western Health and Social Care Trust
    Mdec Building Altnagelvin Area Hospital Site Glenshane Road
    Londonderry
    BT47 6SB
  • Guys and St Thomas' NHS Foundation Trust
    249 Westminster Bridge Road
    London
    SE1 7EH
  • Buckinghamshire Healthcare NHS Trust
    Amersham Hospital Whielden Street
    Amersham
    HP7 0JD
  • London Vascular Clinic
    102 Sydney St
    London
    SW3 6NR
  • St George's University Hospital NHS Foundation Trust
    Blackshaw Road Tooting
    London
    SW17 0QT
  • Veincentre Limited
    Ashley Farm School Lane Ashley
    Market Drayton
    TF9 4LF
  • The Whiteley Clinic
    1 Chapel Pl
    London
    W1G 0BG

Patients who would not normally be given blood thinning medication as standard treatment may be assigned to the blood thinning medication group and thus may have a lower risk of developing a blood clot. Similarly, patients who would have normally received blood thinning medication and may have experienced an adverse reaction to this treatment may be assigned to the group receiving only elastic stockings, thus reducing the likelihood of potentially experiencing an adverse reaction to the medication. In addition to this, participants in all arms of the trial will be monitored closely for any complications of blood thinners and stockings, so that any complications can be detected and acted upon. Participants will have an extra non-invasive leg scan about 3 weeks after their procedure to detect any asymptomatic blood clots in the legs. Patients not entered into the study would not normally be offered this scan unless they showed symptoms.
The trial will be continually monitored for safety and stopped at any time on the recommendation of the data monitoring committee if there is marked clinical harm resulting in a lack of equipoise and it being deemed unethical to continue the trial. A study-specific risk assessment will also be performed prior to the start of the study by the study sponsor. The risk assessment will consider all aspects of the study and will be updated as required during the course of the study.
We do not expect participation to result in any additional burden on the participant. Participants will attend hospital for a duplex venous ultrasound scan 21 days after the procedure, and the researchers will offer reimbursement for travel. Participants will then be followed up remotely at 7 and 90 days after the procedure. Data can be provided by online survey, text or telephone depending on patient preference. Minimal data collection will occur at these follow-ups. Incidental findings may be identified during study assessments, such as the duplex ultrasound scan. Such findings will be reported to the local clinical team and to the participant’s GP.
Blood thinners are offered routinely to people who would be eligible to participate in this study. Possible complications of blood thinners are bleeding, allergy, rash and low numbers of platelets in the blood (platelets help the blood to clot). These are only the complications which could occur; we are not expecting them all to happen to every participant, and the majority of people do not have any complications. The risk of blood clots is higher in pregnant women. Pregnant women therefore should not take part in this study, and neither should women who plan to become pregnant during the 90 days of the study. Women who could become pregnant should use an effective method of contraception during the course of this study. Any woman who finds that she has become pregnant while taking part in the study should inform her research doctor as soon as possible.


The study is sponsored by Imperial College London and funded by Health Technology Assessment Programme.




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Read full details for Trial ID: ISRCTN18501431

Or CPMS 55506

Last updated 06 March 2025

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