Dutch Intraventricular Thrombolysis in Cerebral Haemorrhage study

ISRCTN ISRCTN19105863
DOI https://doi.org/10.1186/ISRCTN19105863
Secondary identifying numbers NTR496
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

Academic Medical Center
Department of Neurology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Phone +31 (0)20 5663842
Email K.deGans@amc.uva.nl

Study information

Study designMulticentre randomised single blind active controlled parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study acronymDITCH
Study objectivesIn 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) studiedIntraventricular haemorrhage, intracerebral haemorrhage
InterventionExternal 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 typeOther
Primary outcome measurePoor outcome at three months (mRankin scale and GOS).
Secondary outcome measures1. Drain dependency at 3 months
2. Amsterdam Linear Disability Scale score at 3 months
3. Intraventricular or parenchymal bleeding complications
4. Ventriculitis
Overall study start date01/02/2006
Completion date01/02/2008

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants46
Key inclusion criteria1. 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 criteria1. 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 enrolment01/02/2006
Date of final enrolment01/02/2008

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Academic Medical Center
Amsterdam
1100 DD
Netherlands

Sponsor information

Academic Medical Centre (AMC) (Netherlands)
University/education

Department of Neurology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

ROR logo "ROR" https://ror.org/03t4gr691

Funders

Funder type

University/education

Academic Medical Centre (AMC) (Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan