Contact information
Type
Scientific
Primary contact
Dr D. Nieuwkamp
ORCID ID
Contact details
University Medical Center Utrecht
Department of Neurology
Heidelberglaan 100
Utrecht
3584 CX
Netherlands
d.nieuwkamp@neuro.azu.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR455
Study information
Scientific title
(Added 14/08/09) Recombinant tissue plasminogen activator (rt-PA) and external ventricular drain (EVD) in subarachnoid haemorrhage (SAH) with obstructive hydrocephalus for lysis of ventricular blood. A randomised clinical trial.
Acronym
RESOLVE
Study hypothesis
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.
Ethics approval
Received from local medical ethics committee
Study design
Single centre prospective randomised double blind placebo controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Aneurysmal subarachnoid haemorrhage, Hydrocephalus, Intraventricular haemorrhage
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
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Death or dependency 6 months after subarachnoid haemorrhage
Secondary outcome measures
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
Overall trial start date
01/09/2005
Overall trial end date
01/09/2009
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
16
Participant 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
Recruitment start date
01/09/2005
Recruitment end date
01/09/2009
Locations
Countries of recruitment
Netherlands
Trial participating centre
University Medical Center Utrecht
Utrecht
3584 CX
Netherlands
Funders
Funder type
Hospital/treatment centre
Funder name
University Medical Centre Utrecht (UMCU) (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary