No registrations found.
ID
Source
Brief title
Health condition
Intraventricular haemorrhage caused by extension of intracerebral haemorrhage.
Sponsors and support
Geinitieerd door de afdeling neurologie van het AMC
Intervention
Outcome measures
Primary outcome
Poor outcome at three months (mRankin scale and GOS).
Secondary outcome
1. Drain dependency at 3 months;
2. Amsterdam Linear Disability Scale score at 3 months;
3. Intraventricular or parenchymal bleeding complications;
4. Ventriculitis.
Background summary
Background - Intraventricular haemorrhage caused by extension from an intracerebral haemorrhage leads to acute hydrocephalus and often to poor outcome. Treatment consists of repeated lumbar puncture or extraventricular drainage but in case of massive intraventricular haemorrhage, repeated lumbar puncture is not an option and extraventricular drainage is often hampered by obstruction of the drain. Moreover, blood clotted drains very often cause ventricular infections also resulting in poor clinical outcome.
In recent years several studies have described intraventricular fibrinolytic treatment in combination with extraventricular drainage to prevent drain obstruction.
In a meta-analysis combining the results of these studies, intraventricular fibrinolytic treatment improved poor clinical outcome from 90% in patients with ventricular drainage without thrombolysis or no drainage at all to 34% in patients treated with intraventricular drainage with fibrinolytic treatment. However, none of the studies in this meta-analysis was randomised, all had an observational design and most included only very few patients. A randomised clinical trial is therefore warranted.
Hypothesis - In patients with intraventricular haemorrhage caused by extension from an intracerebral haemorrhage ventricular drainage combined with intraventricular thrombolysis improves three month outcome when compared to standard treatment.
Study objectives - To investigate whether ventricular drainage combined with intraventricular thrombolysis improves current outcome results in patients with intraventricular haemorrhage caused by extension from an intracerebral haemorrhage.
Methods - The study design is a multicentre randomised controlled clinical trial. Based on the power calculations this study will include 46 patients with intraventricular haemorrhage caused by extension from an intracerebral haemorrhage, 23 in the treatment group and 23 in the control group. With this number of patients we should be able to determine if the treatment is safe and effective.
Expected results - Based on the meta-analysis of the non-randomised studies we expect a reduction of poor outcome of 75% in the group treated with ventricular drainage combined with intraventricular thrombolysis.
Study objective
In patients with intraventricular haemorrhage caused by extension from an intracerebral haemorrhage, ventricular drainage combined with intraventricular thrombolysis improves three month outcome when compared to standard treatment.
Intervention
External ventricular drain(s) placement. Infusion of 3 mg tr-PA through the EVD twice daily with a maximum of six days, compared to extraventricular drainage alone.
Department of Neurology,
P.O. Box 22660
K. Gans, de
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5663842
K.deGans@amc.uva.nl
Department of Neurology,
P.O. Box 22660
K. Gans, de
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5663842
K.deGans@amc.uva.nl
Inclusion criteria
1. Age > 18 years;
2. IVH caused by extension of spontaneous ICH confirmed by CT-scan;
3. Glasgow Coma Score on admission of < 14;
4. Able to include patients within 48 hours after ICH onset;
5. Historical mRankin of 0 or 1.
Exclusion criteria
1. IVH caused by aneurysm or arteriovenous malformation as seen on CT-scan;
2. Only sedimentation of blood in the lateral ventricles;
3. Infratentorial bleeding;
4. Evacuation of parenchymal hematoma is deemed necessary;
5. Clotting disorder;
6. Pregnancy;
7. Epileptic seizure at onset;
8. Absence of brain stem reflexes on admission;
9. If death appears imminent.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL455 |
| NTR-old | NTR496 |
| Other | : N/A |
| ISRCTN | ISRCTN19105863 |