Intracerebral Hemorrhage, Obstructive Hydrocephalus
Conditions
Keywords
intracerebral hemorrhage, intraventricular hemorrhage, hydrocephalus, Intracerebral hemorrhage with severe ventricular involvement and obstructive hydrocephalus
Brief summary
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
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).
Interventions
PROCEDURELumbar drainage
Lumbar CSF drainage is started after communication between the internal and external CSF-spaces is seen on CT.
Sponsors
University of Freiburg
University of Erlangen-Nürnberg Medical School
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Requirement of permanent VP-shunt | 14 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety aspects | during hospital stay | (i) catheter-associated infections (ii) fibrinolysis- and catheter-associated bleedings (iii)overdrainage and herniation |
| mortality and outcome | 3 and 6 months | modified Rankin Scale 3 and 6 months after treatment, as well as in-hospital mortality. |
Countries
Germany
Outcome results
None listed