No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
354 (estimated)
Sponsor
University Hospital Heidelberg · Other
Who this trial is looking for
This trial is looking for adults who have experienced bleeding in the brain and need treatment. Participants will receive a special drainage procedure to help manage their condition and reduce the risk of further complications.
Are You a Good Fit for This Trial?
You may be able to join if
I have a bleeding in the brain that is affecting the ventricles.
I need a drain placed because of swelling in the brain.
I am 18 years or older.
My lumbar drain can be inserted within 72 hours of my symptoms starting.
You may not be able to join if
I had a health score before this condition that was more than 2.
I am pregnant.
My life expectancy is less than 6 months.
I or my family do not want aggressive treatment for at least two weeks.
My doctor believes my situation is too serious for aggressive treatment.
I have another clear reason preventing me from using a lumbar drain.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 i…
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.
Trial Locations
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City
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Status
Eligibility Criteria
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
* P…
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
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