Lumbar drainage in intracerebral haemorrhage with intraventricular haemorrhage (DRAIN IVH): protocol for a multi-centre, randomised-controlled, two-arm, assessor-blinded trial.

BACKGROUND

Intracerebral haemorrhage with ventricular extension is associated with poor neurological outcome and high mortality. External ventricular drainage (EVD) is a standard intervention for acute hydrocephalus in such patients, yet the role of an additional early lumbar drainage (LD) remains uncertain.

AIM: To evaluate whether early LD leads to improved functional outcomes in patients suffering from ICH with intraventricular haemorrhage (IVH) who require an EVD, compared to patients not receiving early LD.

STUDY

DESIGN

DRAIN IVH is a multi-centre, parallel-group, open-label randomised controlled trial with blinded endpoint evaluation. Key inclusion criteria are ICH with IVH in the third and/or fourth ventricle with the need for EVD placement due to acute hydrocephalus, age ≥ 18 years and LD insertion within 72 h after symptom onset or last-seen-well.

SAMPLE SIZE: A total of 354 patients will be randomised for either early LD plus standard of care (comprising EVD) or standard of care alone.

STUDY ENDPOINTS: The primary outcome is the rate of modified Rankin Scale score 0-3 at 180 days. Secondary outcomes include need for VP shunt, need for tracheostomy and EQ-5D. Safety outcomes include mortality, bacterial ventriculitis/meningitis, EVD complications and LD complications.

SUMMARY: DRAIN IVH will provide evidence for physicians whether early LD in addition to standard of care treatment leads to better outcomes in ICH with IVH compared to standard of care alone.

TRIAL REGISTRATION: Clinicaltrials.gov; NCT06510842.