Status:
TERMINATED
WEANING-Study: "Weaning by Early Versus lAte Tracheostomy iN supratentorIal iNtracerebral Bleedings
Lead Sponsor:
University of Erlangen-Nürnberg Medical School
Conditions:
Intracerebral Hemorrhage
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief Summary
Background: One third of all ICH patients require intubation and mechanical ventilation and 1/3 of all ventilated patients require tracheostomy (i.e.≈10% of all ICH patients require tracheostomy). As...
Eligibility Criteria
Inclusion
- Patients requiring intubation / mechanical ventilation
- Supratentorial intracerebral hemorrhage (including:)
- primary spontaneous ICH (lobar / deep)
- ICH related to anticoagulant therapy
- with or without intraventricular hemorrhage
- with or without occlusive and / or communicating hydrocephalus
- Hematoma volume \>0 ml and \<60 ml
- Age 18 - 85 years
- Informed consent (legal representative)
Exclusion
- Patients with elective intubation/ventilation for EVD placement
- Patients with "do not treat" / "do not resuscitate" orders, severe co- morbidity and life expectancy of less than 3 months
- Absent consent of relatives for invasive (neuro-)critical care
- Contraindication for tracheostomy
- Other than primary supratentorial ICH or supratentorial ICH related to oral anticoagulants
- Pre-existing COPD (known/treated)
- Pre-existing congestive heart failure (≥3 NYHA)
- Pre-existing modified Rankin Scale (≥4)
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT01176214
Start Date
July 1 2010
End Date
April 1 2014
Last Update
April 28 2014
Active Locations (1)
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1
University or Erlangen-Nuremberg
Erlangen, Germany, 91054