Condition category
Circulatory System
Date applied
27/01/2006
Date assigned
27/01/2006
Last edited
14/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Sponsor information

Organisation

University Medical Center Utrecht, Department of Neurology (The Netherlands)

Sponsor details

Heidelberglaan 100
Utrecht
3584 CX
Netherlands

Sponsor type

Not defined

Website

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

Publication citations

Additional files

Editorial Notes