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 |
| Secondary identifying numbers | NTR455 |
- Submission date
- 27/01/2006
- Registration date
- 27/01/2006
- Last edited
- 14/08/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
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
Contact information
Dr D. Nieuwkamp
Scientific
Scientific
University Medical Center Utrecht
Department of Neurology
Heidelberglaan 100
Utrecht
3584 CX
Netherlands
| d.nieuwkamp@neuro.azu.nl |
Study information
| Study design | Single centre prospective randomised double blind placebo controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | 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 study start date | 01/09/2005 |
| Completion date | 01/09/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 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 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Medical Center Utrecht
Utrecht
3584 CX
Netherlands
3584 CX
Netherlands
Sponsor information
University Medical Center Utrecht, Department of Neurology (The Netherlands)
Not defined
Not defined
Heidelberglaan 100
Utrecht
3584 CX
Netherlands
"ROR" |
https://ror.org/0575yy874 |
|---|
Funders
Funder type
Hospital/treatment centre
University Medical Centre Utrecht (UMCU) (Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
