Dutch Intraventricular Thrombolysis in Cerebral Haemorrhage study
| ISRCTN | ISRCTN19105863 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN19105863 |
| Protocol serial number | NTR496 |
| Sponsor | Academic Medical Centre (AMC) (Netherlands) |
| Funder | Academic Medical Centre (AMC) (Netherlands) |
- Submission date
- 09/01/2006
- Registration date
- 09/01/2006
- Last edited
- 14/08/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr K. Gans, de
Scientific
Scientific
Academic Medical Center
Department of Neurology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
| Phone | +31 (0)20 5663842 |
|---|---|
| K.deGans@amc.uva.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre randomised single blind active controlled parallel group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | DITCH |
| Study objectives | In patients with intraventricular haemorrhage (IVH) caused by extension from an intracerebral haemorrhage (ICH), ventricular drainage combined with intraventricular thrombolysis improves three month outcome when compared to standard treatment. |
| Ethics approval(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Intraventricular haemorrhage, intracerebral haemorrhage |
| Intervention | External ventricular drain(s) (EVD) placement. Infusion of 3 mg tr-PA through the EVD twice daily with a maximum of six days, compared to extraventricular drainage alone. |
| Intervention type | Other |
| Primary outcome measure(s) |
Poor outcome at three months (mRankin scale and GOS). |
| Key secondary outcome measure(s) |
1. Drain dependency at 3 months |
| Completion date | 01/02/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 46 |
| Key inclusion criteria | 1. Age >18 years 2. IVH caused by extension of spontaneous ICH confirmed by computed tomography (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 |
| Key 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 |
| Date of first enrolment | 01/02/2006 |
| Date of final enrolment | 01/02/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Center
Amsterdam
1100 DD
Netherlands
1100 DD
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
