Eligibility

Local study conflicts

• Patients can be co-enrolled to other clinical trials as administration of thromboprophylaxis is short term and mirrors standard of care treatments.

Inclusion Criteria:

• Adults (>18 years)
• Scheduled to undergo to undergo endovenous intervention of truncal varicose veins under local anaesthesia
• Treatment technologies including radiofrequency, laser, mechanochemical, foam sclerotherapy and cyanoacrylate glue

Exclusion Criteria:

• Clinical indication for therapeutic anticoagulation e.g., atrial fibrillation
• Previous personal or first-degree relative history of VTE
• Thrombophilia
• Female patients of childbearing potential who have a positive pregnancy test
• A history of allergy to heparins or direct oral anticoagulants
• A history of heparin-induced thrombocytopenia
• Inherited and acquired bleeding disorders
• Evidence of active bleeding
• Concomitant major health problems such as active cancer and chronic renal and/or liver impairment
• Known thrombocytopenia (platelets less than 50 x 109/l)
• Major trauma or non-venous surgery that required local risk assessment for VTE in the previous 90 days
• Recent ischemic stroke in the previous 90 days

If the patient is eligible:

• Inform the patient that they may be eligible for a research study
• Gain verbal agreement in principle before proceeding. Explain:
• Taking part in research is likely to improve the quality of their care
• Risks are carefully controlled - research is safe
• Explain the uncertainty that exists with respect to treatment of their condition
• If they change their mind they can withdraw their participation at any point

Step-by-Step Guide to Recruitment:

In standard working hours

• The research nurse team is available from 08am-16pm Monday to Friday;
• In research team working hours contact the team via:
  • Secure Chat: Research Delivery Team EVOCC
  • Email: cuh.rdt@nhs.net

Time taken to recruit

• Thirty minutes

Eligibility confirmation

1. Eligibility can only be confirmed by clinicians on the delegation log.
2. Mr Manjit Gohel, consultant vascular surgeon, is the PI and will know which members of staff who are delegated this role.

When the ED Research team is not available:

• Patients can not be recruited out of normal working hours

Steps to recruit

1. Clinical team to have initial conversation with the patient and ask if details can be passed onto the research nurse team . This could be at an out patient appointment or at time of admission for procedure.
2. Clinic admin staff are also including a short information leaflet with the procedure appointment letter including the research nurse teams contact details so that interested patients can contact the nurse team ahead of their appointment
3. Research nurse team to send out PIS and follow up to see if they are interested.
4. Delegated medical team member to document eligibility on EPIC using smartphrase .THRIVEELIGIBILITY
5. Delegated Research nurses will receive consent and complete all baseline questionnaires

Randomisation procedure

• Research Nurse team will complete randomisation and inform clinical teams so allocated prophylaxis can be prescribed.

Carrying out the intervention:

• Participants will be individually randomised (stratified by site) to one of three thromboprophylaxis strategies prior to undergoing endovenous treatment:
1. Compression* alone
2. Compression* + single dose of low-molecular weight heparin (LMWH) at time of procedure
3. Compression* + single dose of LMWH at time of procedure + extended prophylactic dose of anticoagulation with LMWH or Direct-Acting Oral Anticoagulants (DOAC)**
• *compression bandaging, compression stockings or compression wraps aligning with standard of care
• **7, 10 or 14-day course of prophylactic dose LMWH or DOAC as per local preference
• Local routine prescribing procedures will be followed for each IMP, for example, the IMP will be prescribed by the participant’s treating clinician according to the trial arm allocation and dispensed by the hospital pharmacy.

Disposition and follow-up:

• Follow up is as per standard of care.
• In addition a duplex ultrasound appointment will be made between 21 - 28 days post procedureto test for DVT. If positive, the scanning team will contact the on call vascular consultant for advice.
• The central team will also follow up remotely at 7 days and 90 days post procedure

Links for further information:

Link to trial site