BACKGROUND: Chronic
subdural haematoma causes serious
morbidity and mortality. It recurs after
surgical evacuation in 5-30% of patients. Drains might reduce recurrence but are not used routinely. Our aim was to investigate the effect of drains on recurrence rates and clinical outcomes. METHODS: We did a
randomised controlled trial at one UK centre between November, 2004, and November, 2007. 269 patients
aged 18 years and older with a chronic
subdural haematoma for burr-hole drainage were assessed for eligibility. 108 were
randomly assigned by block
randomisation to receive a drain inserted into the
subdural space and 107 to no drain after evacuation. The primary endpoint was recurrence needing redrainage. The trial was stopped early because of a significant benefit in reduction of recurrence. Analyses were done on an intention-to-treat basis. This study is registered with the International Standard
Randomised Controlled Trial Register (ISRCTN 97314294). FINDINGS: Recurrence occurred in ten of 108 (9.3%) people with a drain, and 26 of 107 (24%) without (p=0.003; 95% CI 0.14-0.70). At 6 months mortality was nine of 105 (8.6%) and 19 of 105 (18.1%), respectively (p=0.042; 95% CI 0.1-0.99). Medical and
surgical complications were much the same between the study groups. INTERPRETATION: Use of a drain after burr-hole drainage of chronic
subdural haematoma is safe and associated with reduced recurrence and mortality at 6 months. FUNDING: Academy of Medical Sciences, Health Foundation, and NIHR Biomedical Research Centre (
Neurosciences Theme).