Difficulties with recruiting into neurosurgical clinical trials: The Surgical Trial in IntraCerebral Haemorrhage II as an example

Abstract

Background: Spontaneous supratentorial intracerebral haemorrhage (ICH) is a devastating condition with a high morbidity and mortality, and uncertainty remains regarding the role of surgery in many cases. The Surgical Trial in IntraCerebral Haemorrhage II (STICH II) was initiated to look at subjects with superficial lobar ICH, as the initial STICH trial showed the greatest benefit from early surgery in this subgroup. Our aim was to estimate how many patients with ICH referred to the Greater Manchester Neurosciences Centre (GMNC) met the inclusion and exclusion criteria of the STICH II trial.

Methods: The number of patients eligible for STICH II was determined from the GMNC referral database and admissions to the stroke unit over 1 year (2008). Eligibility was determined by predefined criteria, and equipoise was agreed by two consultant neurosurgeons.

Results: One hundred and sixty-eight (38.7%) of 434 ICH referrals were lobar ICH; 53 (31.5% of lobar ICH) of these met the radiological and Glasgow Coma Scale (GCS) criteria for STICH II, but only 16 (9.5% of lobar ICH; 3.7% of all ICH) had equipoise agreed on by two neurosurgeons. Thirty-five ICH patients were admitted to the stroke unit, and 12 (34.3%) of these had lobar ICH; none were eligible for STICH II.

Conclusions: The number of patients eligible for recruitment into STICH II is small, necessitating an aggressive recruitment approach. Recruitment should focus on neuroscience centres with neurosurgical units as opposed to stroke units.

Key words:

• STICH II
• lobar intracerebral haemorrhage
• eligibility
• neurosurgical clinical trial

Declaration of interest: The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the paper.