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| Name | Class |
|---|---|
| University of Freiburg | OTHER |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lumbar drainage | Experimental |
| |
| Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lumbar drainage | Procedure | Lumbar CSF drainage is started after communication between the internal and external CSF-spaces is seen on CT. |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hagen Huttner, MD | Neurology Department, University of Erlangen-Nuremberg | Principal Investigator |
| Dimitre Staykov, MD | Neurology Department, University of Erlangen-Nuremberg | Principal Investigator |
| Jürgen Bardutzky, MD | University of Freiburg | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neurology Department, University of Erlangen-Nuremberg | Erlangen | 91054 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27888608 | Derived | Staykov D, Kuramatsu JB, Bardutzky J, Volbers B, Gerner ST, Kloska SP, Doerfler A, Schwab S, Huttner HB. Efficacy and safety of combined intraventricular fibrinolysis with lumbar drainage for prevention of permanent shunt dependency after intracerebral hemorrhage with severe ventricular involvement: A randomized trial and individual patient data meta-analysis. Ann Neurol. 2017 Jan;81(1):93-103. doi: 10.1002/ana.24834. |
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| 3 and 6 months |
| ID | Term |
|---|---|
| D002543 | Cerebral Hemorrhage |
| D006849 | Hydrocephalus |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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