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


- candidate number1761
- NTR NumberNTR455
- ISRCTNISRCTN36786212
- Date ISRCTN created27-jan-2006
- date ISRCTN requested18-nov-2005
- Date Registered NTR13-okt-2005
- Secondary IDsN/A 
- Public TitleIntraventricular infusion of rt-PA in severe intraventricular haemorrhage after aneurysmal subarachnoid haemorrhage. A randomised clinical trial.
- Scientific Titlert-PA and EVD in SAH with obstructive hydrocefalus for lysis of ventricular blood. A randomised clinical trial.
- ACRONYMRESOLVE
- hypothesisIntraventricular infusion of rt-PA reduces the frequency of poor outcome (death or dependency) in patients with a severe intraventricular haemorrhage after aneurysmal subarachnoid hemorrhage.
- Healt Condition(s) or Problem(s) studiedAneurysmal subarachnoid hemorrhage, Hydrocephalus, Intraventricular haemorrhage
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 1-sep-2005
- planned closingdate1-sep-2009
- Target number of participants16
- Interventions1. 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.
- Primary outcomeDeath or dependency 6 months after subarachnoid haemorrhage.
- Secondary outcome1. 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.
- Timepoints
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES D. Nieuwkamp
- CONTACT for SCIENTIFIC QUERIES D. Nieuwkamp
- Sponsor/Initiator University Medical Center Utrecht (UMCU), Department of Neurology
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Utrecht (UMCU)
- PublicationsN/A
- Brief summaryThe 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.
- Main changes (audit trail)
- RECORD13-okt-2005 - 7-mrt-2006


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