Trial Design and Oversight
subarachnoid hemorrhage, aneurysm
SUBARACHNOID HEMORRHAGE, ANEURYSM
The EARLYDRAIN trial was a pragmatic, multicenter, parallel-group, open-label randomized clinical trial with blinded end point evaluation performed in 19 hospitals in Germany, Switzerland, and Canada. Trial sites were referral centers that provided acute neurosurgical and neurocritical care for patients with subarachnoid hemorrhage on a 24-hour basis with at least 30 aneurysm procedures per year. The protocol included a statistical analysis proposal and was published at the start of the trial,Lead ethics approval was obtained from the research Ethics Committee of the University of Erlangen, Germany. The trial was approved locally from the corresponding ethics board at each participating center. If possible, written informed consent was obtained from the patient before the aneurysm treatment procedure. In patients unable to consent, a legally authorized representative was asked for permission. If this person required court approval not available in due time, a physician not involved in the EARLYDRAIN trial was allowed to consent as a surrogate on the presumed will of a capable person, according to German law. Later stepwise approval by the designated person and finally the patient themselves was obtained. In Switzerland and Canada, approval for study inclusion was granted by the next of kin, as required by local laws.