Lumbar Drainage of Intraventricular Hemorrhage the DRAIN IVH Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 354
- Locations
- 3
- Primary Endpoint
- Rate of mRS
Study Overview
Brief Summary
Intracerebral hemorrhage (ICH) is a debilitating and fatal disease, especially when the hemorrhage is also entering the cerebral ventricles leading to acute hydrocephalus. In these cases, patients need a drainage through external ventricular drains (EVD). In the longer term, patients often need a permanent ventriculoperitoneal (VP) shunt to avoid hydrocephalus. Here we hypothesize that the early insertion of a lumbar drainage in addition to the EVD could lead to better functional outcome and avoidance of VP shunting by drainage of the blood which promotes inflammatory and adverse effects in the subarachnoid space. For that we propose a multi-center randomized clinical trial to investigate the hypothesis.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •ICH with IVH (with hemorrhage in the 3rd and/or 4rth ventricle) with the need for EVD placement due to acute hydrocephalus
- •Age ≥ 18 y
- •Lumbar drain can be inserted within 72 h after symptom onset or patient last seen well
Exclusion Criteria
- •Premorbid mRS score > 2
- •Pregnancy
- •Life expectancy <6 months
- •Patient/family/caregiver unwilling or unlikely to opt for at least two weeks of aggressive therapy prior to consideration of transition to comfort measures/discontinuation of life support measures.
- •Treating physicians deeming the prognosis as so grave that an aggressive therapy is not warranted.
- •Other clear contraindication for treatment with a lumbar drain
Arms & Interventions
Intervention arm
Additional insertion of a lumbar drainage.
Intervention: External drainage of intraventricular hemorrhage (Other)
Control arm
Standard of care consists of drainage of CSF via EVD with or without intraventricular thrombolysis.
Intervention: External drainage of intraventricular hemorrhage (Other)
Outcomes
Primary Outcomes
Rate of mRS
Time Frame: 180 days (+/- 14 days)
The mRS is frequently employed to assess functional outcome of stroke therapy - its ease of use, simplicity of interpretation for clinicians and families, and agreement with other stroke scales are appealing features. The use of fixed dichotomous analysis of ordered categorical outcomes after stroke (mRS 0-3 favorable vs. 4-6 non-favorable outcome) has proved to be valid and reliable for defining outcome in stroke patients in many previous studies.
Secondary Outcomes
- Clearance of intraventricular blood (via neuroimaging with CT or MRI)(up to 14 days (duration of hospital stay))
- Amount of CSF drained by external ventricular drain(up to 14 days (duration of hospital stay))
- Need for VP shunt(at 180 days)
- Bacterial Ventriculitis/Meningitis leading to antibiotic treatment(up to 14 days (duration of hospital stay))
- Amount of CSF drained by lumbar drain(up to 14 days (duration of hospital stay))
- Mortality(up to 14 days (duration of hospital stay) and 6 month)
- Need for VP shunt(up to 14 days (duration of hospital stay))
Investigators
Dr. Silvia Schönenberger, MD
Prof. Dr. Silvia Schönenberger
University Hospital Heidelberg