AVM formation post Glenn operation

• Research type

  Research Study

• Full title

  Investigation of Angiogenic Pathways involved in the Pathogenesis of Pulmonary Arterio-Venous Malformations in Single Ventricle Patients following the Glenn and TCPC procedures.

• IRAS ID

  247734

• Contact name

  John O'Sullivan

• Contact email

  john.o'sullivan@nuth.nhs.uk

• Sponsor organisation

  Joint research office, Newcastle upon Tyne NHS Foundation Trust

• Duration of Study in the UK

  2 years, 11 months, 30 days

• Research summary

  Some children are born with only one (instead of two) ventricles and they usually undergo a series of operations in the first years of life to separate the blue (deoxygenated blood) from the red (oxygenated blood). The first operation that is carried out to achieve this is called the Glenn shunt where the upper body veins are connected to the lungs and then, usually at age 3 – 5 years, the lower body veins are connected to the lungs – this is called the Total Cavo Pulmonary Connection (TCPC).

  The Glenn shunt is complicated by the development of abnormal connections within the lung and these are called arterio-venous malformations (AVMs) and can cause low oxygen levels in the blood, leading to breathlessness. There are a number of factors (proteins) in the blood which may be implicated in forming these AVMs.

  This observational study proposes to measure certain candidate proteins before and after the Glenn operation so that we can make progress towards developing a strategy which may stop progression of these malformations and improve outcomes for patients. Although the AVMs resolve when the lower vein is connected (in the second operation mentioned above, the TCPC), it would be advantageous to the patient to delay this second operation for as long as possible to minimise the time that hepatic pressure is elevated as that is an inevitable consequence of the TCPC circulation.

  This study does involve taking a small amount of additional blood from the patient either at the time of surgery, at cardiac catheter or in ITU (estimated amount to be less than 8 mls). This additional blood sampling should not cause discomfort, as patient will be anaesthetised, or any increase risk to patient. The results will help inform further study in this important area.

• REC name

  London - Central Research Ethics Committee

• REC reference

  19/LO/1003

• Date of REC Opinion

  16 Jul 2019

• REC opinion

  Further Information Favourable Opinion