Condition category
Circulatory System
Date applied
09/01/2006
Date assigned
09/01/2006
Last edited
14/08/2009
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

Sponsor information

Organisation

Academic Medical Centre (AMC) (Netherlands)

Sponsor details

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

Sponsor type

University/education

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes