Lumbar Drainage of Intraventricular Hemorrhage The DRAIN IVH Randomized Controlled Trial

What this Trial Is About

This research aims to evaluate whether adding lumbar drainage to the standard external ventricular drain (EVD) treatment improves outcomes for patients with intracerebral hemorrhage (ICH) involving bleeding into the brain's ventricles. This condition often causes acute hydrocephalus, requiring drainage. The study tests the idea that early lumbar drainage may help clear blood and reduce inflammation in the brain's fluid spaces, potentially avoiding the need for permanent ventriculoperitoneal (VP) shunts. The trial is a multi-center randomized clinical study led by University Hospital Heidelberg. Participants in the trial will be randomly assigned to one of two groups: one receiving the standard care of cerebrospinal fluid drainage via EVD, possibly combined with intraventricular clot dissolving treatments, and the other group receiving this standard care plus an additional lumbar drain inserted within 72 hours of symptoms. The study involves careful management of drainage devices and monitoring by local investigators, who will decide on timing and use of additional treatments like fibrinolysis. Throughout the hospital stay of up to 14 days, researchers will track the amount of cerebrospinal fluid drained, clearance of blood from the ventricles using imaging tests, need for VP shunting, and any infections like ventriculitis or meningitis. The primary outcome is the functional status of patients measured by the modified Rankin Scale about six months after treatment. Mortality rates will also be recorded at hospital discharge and 6 months. Safety and functional outcomes will guide evaluation of the lumbar drainage approach over the study duration.

Lumbar Drainage of Intraventricular Hemorrhage