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Intraventricular infusion of rt-PA in severe intraventricular haemorrhage after aneurysmal subarachnoid haemorrhage. A randomised clinical trial.

rt-PA and EVD in SAH with obstructive hydrocefalus for lysis of ventricular blood. A randomised clinical trial.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON28831
Enrollment
16
Registered
2005-10-13
Start date
2005-09-01
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

Aneurysmal subarachnoid haemorrhage, hydrocephalus, intraventricular haemorrhage.

Interventions

1. Placement of external ventricular drain (standard procedure)
2. Clipping / Coiling of ruptured aneurysm (standard procedure)
3. Infusion of rt-PA or placebo through external ventricular drain.

Sponsors

University Medical Center Utrecht
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. First or recurrent aneurysmal subarachnoid haemorrhage with intraventricular extension of the haemorrhage; 2. The ventricles must be enlarged and the intraventricular haemorrhage must be severe (Graeb-score more than 6); 3. Patients must be in a poor neurological condition, WFNS < 7 or WFNS < 6 in intubated patients.

Exclusion criteria

Exclusion criteria: 1. Other cause for intraventricular haemorrhage than a subarachnoid haemorrhage from a ruptured intracranial aneurysm; 2. Absence of both pupillary light reflexes; 3. Use of oral anticoagulants; 4. Treating physicians propose a palliative instead of curative treatment strategy; 5. Absence of informed consent.

Design outcomes

Primary

MeasureTime frame
Death or dependency 6 months after subarachnoid haemorrhage.

Secondary

MeasureTime frame
1. Recurrent haemorrhage; 2. Secondary ischaemia; 3. Hydrocephalus; 4. Bleeding complications from fibrinolysis; 5. Death within 6 months; 6. Rankin 0 versus Rankin 1-5 and death.

Contacts

Public ContactD. Nieuwkamp

University Medical Center Utrecht (UMCU), Department of Neurology, Heidelberglaan 100

d.nieuwkamp@neuro.azu.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)