Edinburgh Clinical Trials

About the Study

Key study information and aims

What is the CARE Study?

The Cavernomas A Randomised Effectiveness (CARE) pilot study aims to address the effectiveness of active treatment (with neurosurgery or stereotactic radiosurgery) versus conservative management in people with symptomatic brain cavernoma.

About 160 people in the UK each year are diagnosed with a cavernoma that has caused symptoms. Stroke and seizure may lead to disability, handicap and occasionally death. In standard practice in the UK, most people with cavernomas have medical management (which may involve scans, drugs, or rehabilitation) to manage these symptoms. About one fifth also have ‘surgical management’ with either brain surgery to remove a cavernoma or stereotactic radiosurgery to stabilise it with radiation. Surgical management can cause death, disability, and handicap.

The pros and cons of medical management versus medical and surgical management are finely balanced. The most reliable way of finding out which management is best is to do a randomised study, in which suitable patients are allocated to medical management or medical and surgical management at random. This has never been done with cavernomas, and this was the top priority identified by a Priority Setting Partnership for cavernoma.

The NIHR (National Insitute for Health Research) wants research to be done to find out whether enough patients can be found for a randomised study comparing ‘medical management with ‘medical and surgical management’ of symptomatic cavernomas. We need to know this because cavernomas are rare and we do not know whether patients and doctors will take part.

What are the aims of the study?

In the three years that the study will be active the aims are:

  • Create a network of specialists to do this study. We will include the UK and Ireland patient support organisations for people with cavernoma (Cavernoma Alliance UK - CAUK) and doctors representing the relevant specialties at all the major hospitals specialising in decisions about cavernoma treatment in the UK and Ireland.

  • Invite newly diagnosed patients to join a pilot phase of a randomised controlled study. Of 190 people diagnosed with brain cavernoma in 18 months, we estimate that 60 of them will enrol in the randomised study. We will study why some patients take part in the randomised study and others don't. We will use this information to change the methods of the study if recruitment to the randomised study goes slowly.

  • Estimate whether enough patients can be found for a full-scale randomised study to be done to find out whether medical management or medical and surgical management of symptomatic brain cavernomas is best.

Have cavernoma patients been involved in the development of this study?

We involved people with cavernoma, carers, and representatives of CAUK with patients and carers at a focus group held in July 2019: all approved the design of the project and the extent of patient and public involvement. The focus group wanted the studies to be as inclusive of patients as possible. The focus group recognised how the project would benefit from them contributing their 'lived experience' of brain cavernoma.

People with cavernoma, carers, and representatives of CAUK will also keep an eye on the research by forming an advisory group and meeting regularly to discuss the research. Two representatives of this group will join and advise the steering committee.

Will the results of the study be published?

We will publish our findings in medical journals. We will work with CAUK to produce a plain English summary and circulate it to patients via newsletters, email, the web, and social media.

Where can I find out more details about the Study?

More information about the study can be found on the Get Involved page – Link

If you have questions, you can contact:

A member of the trial office – care.trial@ed.ac.uk

A member of Cavernoma Alliance UK - CARE@cavernoma.org.uk / 01305 213 876

 

ISRCTN Number: 41647111