Safety and efficacy evaluation of procedures on cranial venous outflow
Research type
Research Study
Full title
Safety and efficacy evaluation of interventional procedures to mitigate cranial venous outflow insufficiency in patients with, and without, proven cerebrospinal fluid leaks: a prospective adaptive observational cohort study.
IRAS ID
343706
Contact name
John Nicholas Peter Higgins
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust
Duration of Study in the UK
5 years, 4 months, 1 days
Research summary
Cranial venous outflow insufficiency (CVOI) is a medical term used to describe partial obstruction to the free flow of blood out of the head due to narrowing or blockage in any of the veins draining blood back to the heart. Symptoms are the result of congestion in the brain and high pressure in the head. Sometimes the obstruction is obvious and the diagnosis easy, such as when a large tumour blocks the major veins in the neck. Often the diagnosis is very difficult, subtle forms of venous obstruction being easily overlooked, partly because the symptoms (headache, fatigue, memory impairment and confusion, for example) are not usually perceived to be caused by physical disease and partly because it is difficult to tell whether a particular narrowing or blockage, in amongst all the veins that drain the head, is important or not.
This study will look at these more subtle cases. The aim is to improve our understanding of the symptoms caused by CVOI and whether they can be relieved safely by addressing the site or sites, of venous obstruction. In some cases, this includes the symptoms caused by leakage of cerebrospinal fluid (CSF - the watery fluid that bathes and supports the brain and spinal cord), which itself can be a complication of obstructed cranial venous outflow.
In this study, we will follow the progress of a group of patients with typical symptoms, who appear to have narrowings or blockages in the veins draining the brain and who have had procedures to deal with them. We will measure any improvements or other changes using health questionnaires and show how safe the treatments are by recording any complications that occur. The study will likely follow patients for several years, but results will be shared (published) at intervals during that time.REC name
East of England - Cambridge East Research Ethics Committee
REC reference
25/EE/0133
Date of REC Opinion
14 Jul 2025
REC opinion
Further Information Favourable Opinion