Intraventricular infusion of rt-PA in severe intraventricular haemorrhage after aneurysmal subarachnoid haemorrhage. A randomised clinical trial.
Recruiting
- Conditions
- Aneurysmal subarachnoid haemorrhage, hydrocephalus, intraventricular haemorrhage.
- Registration Number
- NL-OMON28831
- Lead Sponsor
- niversity Medical Center Utrecht
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 16
Inclusion Criteria
1. First or recurrent aneurysmal subarachnoid haemorrhage with intraventricular extension of the haemorrhage;
2. The ventricles must be enlarged and the intraventricular haemorrhage must be severe (Graeb-score more than 6);
3. Patients must be in a poor neurological condition, WFNS < 7 or WFNS < 6 in intubated patients.
Exclusion Criteria
1. Other cause for intraventricular haemorrhage than a subarachnoid haemorrhage from a ruptured intracranial aneurysm;
2. Absence of both pupillary light reflexes;
3. Use of oral anticoagulants;
4. Treating physicians propose a palliative instead of curative treatment strategy;
5. Absence of informed consent.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Death or dependency 6 months after subarachnoid haemorrhage.
- Secondary Outcome Measures
Name Time Method 1. Recurrent haemorrhage;<br>2. Secondary ischaemia;<br>3. Hydrocephalus;<br>4. Bleeding complications from fibrinolysis;<br>5. Death within 6 months;<br>6. Rankin 0 versus Rankin 1-5 and death.