A Randomised Controlled Trial of Lumbar Drainage to Treat Communicating Hydrocephalus After Severe Intraventricular Hemorrhage

Study Overview
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Brief Summary
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The purpose of this study is to determine if usage of early lumbar drainage leads to less shunt surgery and less catheter associated complications in patients with communicating hydrocephalus after intracerebral hemorrhage with severe ventricular involvement.

Detailed Description
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All patients requiring external ventricular drain (EVD) for treatment of acute obstructive hydrocephalus receive intraventricular fibrinolysis with rt-PA via the ventricular catheter. Lumbar drainage (LD) is inserted at a timepoint, when communication between the internal and the external CSF-spaces is recognizable on CT (opening of third and fourth ventricle and aqueduct).

Official Title
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Lumbar Drainage for Communicating Hydrocephalus After Intraventricular Hemorrhage: a Randomised, Controlled Trial(LUCAS-IVH: LUmbar CAtheter for Severe IntraVentricular Hemorrhage)

Conditions
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Intracerebral Hemorrhage, Obstructive Hydrocephalus

Intervention / Treatment
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* Procedure: Lumbar drainage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: supratentorial intracerebral hemorrhage <60ml intraventricular hemorrhage with casting of the third and fourth ventricles obstructive hydrocephalus with need of external ventricular drainage GCS <9 on admission or within 48h of symptom onset admission within 48h of symptom onset preceding modified Rankin scale ≤3 age 18-85 years Exclusion Criteria: ICH related to oral anticoagulation, trauma, tumor, arteriovenous malformation, aneurysm, systemic thrombolysis or sinus thrombosis infratentorial hemorrhage pregnancy admission 48h after symptom onset preceding modified Rankin scale >3

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lumbar drainage<br> | Procedure: Lumbar drainage<br>* Lumbar CSF drainage is started after communication between the internal and external CSF-spaces is seen on CT.<br>|
| No Intervention: Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Requirement of permanent VP-shunt | if three attempts to clamp the EVD (control group) or LD (treatment group) fail, or overall extra-corporal drainage time exceeds 14 days, a VP-shunt is placed. | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety aspects | (i) catheter-associated infections (ii) fibrinolysis- and catheter-associated bleedings (iii)overdrainage and herniation | during hospital stay | 
| mortality and outcome | modified Rankin Scale 3 and 6 months after treatment, as well as in-hospital mortality. | 3 and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intracerebral hemorrhage, intraventricular hemorrhage, hydrocephalus, Intracerebral hemorrhage with severe ventricular involvement and obstructive hydrocephalus