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.
ID
Bron
Verkorte titel
Aandoening
Aneurysmal subarachnoid haemorrhage, hydrocephalus, intraventricular haemorrhage.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Death or dependency 6 months after subarachnoid haemorrhage.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksproduct en/of interventie
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.
Publiek
Department of Neurology,
Heidelberglaan 100
D. Nieuwkamp
Heidelberglaan 100
Utrecht 3584 CX
The Netherlands
d.nieuwkamp@neuro.azu.nl
Wetenschappelijk
Department of Neurology,
Heidelberglaan 100
D. Nieuwkamp
Heidelberglaan 100
Utrecht 3584 CX
The Netherlands
d.nieuwkamp@neuro.azu.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL415 |
| NTR-old | NTR455 |
| Ander register | : N/A |
| ISRCTN | ISRCTN36786212 |