VOPIC Feasibility Study version 1.0

• Research type

  Research Study

• Full title

  Venous Outflow changes in Patients undergoing deep venous Iliofemoral reCanalisation.

• IRAS ID

  269832

• Contact name

  Richard Simpson

• Contact email

  richard.simpson@nuh.nhs.uk

• Sponsor organisation

  Nottingham University Hospitals NHS Trust

• Duration of Study in the UK

  2 years, 0 months, 0 days

• Research summary

  Veins are tubes that take the blood in your body back to the heart. Veins can become narrowed or blocked. A blockage in a deep vein is called a DVT (deep vein thrombosis). A DVT makes it harder for the blood to flow through the vein and back to the heart. In this study, we are interested in the veins in the lower abdomen and top of the thigh (iliofemoral veins) because these are common problem areas.
  Blockages in the veins can be opened up, using a keyhole procedure called a venoplasty. Here, a small balloon is inserted and inflated in the vein to widen it. A metal stent may also be used to help keep the vein open and increase blood flow. These blockages or narrowings in the veins may be recent or more long term and we are interested in the both types. Patients may have symptoms of severe leg swelling, pain, and skin discolouration.

  This study will look at the blood flow through these veins (venous outflow) before and after this procedure. A method called plethysmography will be used to detect the changes in blood flow in the veins and we will use blood pressure cuffs to do this.

  We will also perform an ultrasound scan (using jelly and similar to a pregnancy scan) to look at the veins in the abdomen and legs. Leg size will be measured using a tape measure and symptoms will be documented using simple questionnaires.
  This study might make it easier to measure blood flow in veins in the future. The information might also help to predict whether metal stents may develop problems. If it is successful, plethysmography tests could be used in patients with vein problems in the future, as it is allows us to assess the severity of the vein problems.

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  19/EM/0324

• Date of REC Opinion

  8 Nov 2019

• REC opinion

  Favourable Opinion