Patient Characteristics
RECRUITMENT
The first patient was enrolled January 31, 2011. After 300 randomizations, 7 allocation failures were known, and the data monitoring and safety board decided to replace these. On January 24, 2016, recruitment in the EARLYDRAIN trial finished after 307 randomizations. A total of 152 randomizations indicated standard of care treatment and 155 were referred to additional placement of a lumbar drain. Eleven randomizations in the lumbar drain group and 9 in the standard of care group lacked complete inclusion criteria or had an exclusion criterion emerging. Main reasons for invalid randomizations were lack of or withdrawn informed consent and a requirement of high-grade therapeutic anticoagulation unforeseeable at the time of randomization. (