Contact information
Type
Scientific
Primary contact
Dr K. Gans, de
ORCID ID
Contact details
Academic Medical Center
Department of Neurology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
+31 (0)20 5663842
K.deGans@amc.uva.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR496
Study information
Scientific title
Acronym
DITCH
Study hypothesis
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
Ethics approval received from the local medical ethics committee
Study design
Multicentre randomised single blind active controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measure
Poor outcome at three months (mRankin scale and GOS).
Secondary outcome measures
1. Drain dependency at 3 months
2. Amsterdam Linear Disability Scale score at 3 months
3. Intraventricular or parenchymal bleeding complications
4. Ventriculitis
Overall trial start date
01/02/2006
Overall trial end date
01/02/2008
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
46
Participant 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
Recruitment start date
01/02/2006
Recruitment end date
01/02/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
Academic Medical Center
Amsterdam
1100 DD
Netherlands
Funders
Funder type
University/education
Funder name
Academic Medical Centre (AMC) (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list