No registrations found.
ID
Source
Brief title
Health condition
Aneurysmal subarachnoid haemorrhage, hydrocephalus, intraventricular haemorrhage.
Sponsors and support
Intervention
Outcome measures
Primary outcome
Death or dependency 6 months after subarachnoid haemorrhage.
Secondary outcome
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.
Background summary
The Resolve study is a prospective randomized, placebo-controlled, monocenter trial to determine whether intraventricular infusion of rt-PA reduces the frequency of poor outcome (death or dependence) in patients with a severe intraventricular haemorrhage after aneurysmal subarachnoid hemorrhage.
Study objective
Intraventricular infusion of rt-PA reduces the frequency of poor outcome
(death or dependency) in patients with a severe intraventricular haemorrhage after aneurysmal subarachnoid hemorrhage.
Intervention
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.
Department of Neurology,
Heidelberglaan 100
D. Nieuwkamp
Heidelberglaan 100
Utrecht 3584 CX
The Netherlands
d.nieuwkamp@neuro.azu.nl
Department of Neurology,
Heidelberglaan 100
D. Nieuwkamp
Heidelberglaan 100
Utrecht 3584 CX
The Netherlands
d.nieuwkamp@neuro.azu.nl
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL415 |
| NTR-old | NTR455 |
| Other | : N/A |
| ISRCTN | ISRCTN36786212 |