Lumbar Drainage of Intraventricular Hemorrhage
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital Heidelberg
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
External drainage of intraventricular hemorrhage
Other interventionAn EVD is required to be eligible for the DRAIN IVH study. Weaning from the EVD is at the discretion of the local investigators. Imaging is at discretion of local investigators. Use, timing and frequency of fibrinolysis via EVD is at local discretion, too.
Treatment groups
354 Participants
are divided into 2 treatment groupsGroup A: Intervention armExperimental treatment 1 intervention
Group B: Control armActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Rate of mRS
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.
Time frame
180 days (+/- 14 days)Secondary outcomes
1
Amount of CSF drained by external ventricular drain
in ml
Time frame
up to 14 days (duration of hospital stay)2
Amount of CSF drained by lumbar drain
in ml
Time frame
up to 14 days (duration of hospital stay)3
Need for VP shunt
operative implantation of VP shunt
Time frame
up to 14 days (duration of hospital stay)4
Need for VP shunt
operative implantation of VP shunt
Time frame
at 180 daysSponsors and contacts
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Source ClinicalTrials.gov