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Dutch Intraventricular Trombolysis in Cerebral Haemorrhage study.

Dutch Intraventricular Trombolysis in Cerebral Haemorrhage study.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON20122
Enrollment
46
Registered
2005-11-05
Start date
2006-02-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intraventricular haemorrhage caused by extension of intracerebral haemorrhage.

Interventions

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.

Sponsors

Geen sponsor. Geinitieerd door de afdeling neurologie van het AMC
Lead Sponsor

Eligibility

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
Poor outcome at three months (mRankin scale and GOS).

Secondary

MeasureTime frame
1. Drain dependency at 3 months; 2. Amsterdam Linear Disability Scale score at 3 months; 3. Intraventricular or parenchymal bleeding complications; 4. Ventriculitis.

Contacts

Public ContactK. Gans, de

Acedemic Medical Center (AMC), Department of Neurology, P.O. Box 22660

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

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)