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Cavernomas: a randomised effectiveness (CARE) trial: treatment with versus without neurosurgery for symptomatic brain cavernoma
  1. Kirsty Harkness1,
  2. Elaine Kinsella2,
  3. Julia Wade3,
  4. Neil Kitchen4,
  5. Rustam Al-Shahi Salman2,5,
  6. CARE pilot trial collaboration6
  1. 1Sheffield Teaching Hospital Trust
  2. 2Edinburgh Clinical Trials unit,Edinburgh University
  3. 3QuinteT
  4. 4NHNN, UCLH
  5. 5Edinburgh Clinical Trials unit, centre for clinical Brain sciences, Edinburgh University
  6. 6UK and Ireland Neurosciences

Abstract

Objectives We are conducting a feasibility and pilot phase randomised controlled trial (RCT) to address the top uncertainty about cavernomas, does treatment with surgery (neurosurgery or stereotactic radio- surgery) improve outcome, compared to treatment without surgery?

Methods Feasibility study and pilot phase, parallel group,pragmatic RCT involving ~60 participants. Par- ticipants are randomised 1:1 to treatment with surgery or treatment without surgery. The primary clinical outcome is symptomatic intracranial haemorrhage or new persistent focal neurological deficit. Collabora- tors keep screening logs capturing characteristics of patients screened, eligible,approached, consented and randomised. A Quinte T recruitment intervention is evaluating screening logs and audio recordings of recruitment discussions and interviews with recruiters and patients.

Results The first site opened in August 2021.14 (47%) of our target of 30 sites are currently active.Six sites are pending activation. The first patient was recruited in September 2021.on 14 January, of 35 patients screened,17 (49%) were approached to assess eligibility, 10 (29%) were eligible, and three (9% of those screened and 5% of the n=60 target ) were randomised.

Conclusions We are grateful to neurologists for supporting this multidisciplinary collaboration to demons- trate the feasibility of resolving the top uncertainty about brain cavernoma in a definitive main phase trial.

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