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

ISRCTN	ISRCTN36786212
DOI	https://doi.org/10.1186/ISRCTN36786212
Protocol serial number	NTR455
Sponsor	University Medical Center Utrecht, Department of Neurology (The Netherlands)
Funder	University Medical Centre Utrecht (UMCU) (Netherlands)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr D. Nieuwkamp
Scientific

University Medical Center Utrecht
Department of Neurology
Heidelberglaan 100
Utrecht
3584 CX
Netherlands

Email	d.nieuwkamp@neuro.azu.nl

Primary study design	Interventional
Study design	Single centre prospective randomised double blind placebo controlled parallel group trial
Secondary study design	Randomised controlled trial
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.
Study acronym	RESOLVE
Study objectives	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(s)	Received from local medical ethics committee
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Death or dependency 6 months after subarachnoid haemorrhage
Key secondary outcome measure(s)	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
Completion date	01/09/2009

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	16
Key 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
Key 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
Date of first enrolment	01/09/2005
Date of final enrolment	01/09/2009

University Medical Center Utrecht

Utrecht
3584 CX
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan