Concomitant intraventricular fibrinolysis and low-frequency rotation after severe subarachnoid hemorrhage
| ISRCTN | ISRCTN13230264 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13230264 |
| Secondary identifying numbers | Study ID: 3062 |
- Submission date
- 18/07/2012
- Registration date
- 03/09/2012
- Last edited
- 26/05/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
A subarachnoid haemorrhage (SAH) is a type of stroke that is most often caused by a bulge in a brain blood vessel (aneurysm) bursting and bleeding into the subarachnoid space surrounding the brain. It is a life-threatening disease and those patients who survive the early bleeding are at risk of developing secondary complications such as delayed cerebral ischemia (DCI), a form of secondary stroke. In general, DCI is the major cause of poor outcome and death after SAH. One of the major contributors to DCI is the amount of blood in the subarachnoid space, and reducing the subarachnoid blood has been found to decrease DCI. Therefore the aim of this study is to assess the effect of blood clearance using a blood resolving agent (rt-PA) in patients with severe aneurysmal SAH.
Who can participate?
Patients aged over 18 with severe aneurysmal SAH
What does the study involve?
Participants are randomly allocated to one of two groups. One group is treated with rt-PA via a standard monitoring catheter (tube) into the brain chambers (ventricles) whilst being slowly rotated on a moving bed for 48 hours. The other group receives treatment as usual. Both groups are followed up to assess their neurological (mental) outcome and undergo CT scans to check for cerebral infarctions (brain damage).
What are the possible benefits and risks of participating?
By reducing the amount of blood in the subarachnoid space, DCI and poor neurological outcome may be prevented. One possible risk of rt-PA is an increased risk of bleeding in the brain (intracranial) or in the rest of the body (systemic). However, based on previous studies, the risk of side effects is very low.
Where is the study run from?
Heinrich-Heine University (Germany)
When is the study starting and how long is it expected to run for?
December 2008 to September 2011
Who is funding the study?
Heinrich-Heine University (Germany)
Who is the main contact?
Prof. Daniel Hänggi
Contact information
Scientific
Department of Neurosurgery
Heinrich-Heine University
Moorenstr. 5
Düsseldorf
40225
Germany
Study information
| Study design | Single-center randomized controlled phase IIb study with blinded outcome analysis |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Prospective, randomized, phase IIb trial on concomitant intraventricular fibrinolysis and low-frequency rotation after severe subarachnoid hemorrhage |
| Study objectives | To test whether increased wash-out of subarachnoid blood by intraventrikular fibrinolysis and low-frequency rotation can reduce the incidence of secondary brain injury and poor outcome after aneurysmal subarachnoid hemorrhage (SAH). |
| Ethics approval(s) | Local Institutional Ethics Committee of the Medical Faculty of Heinrich-Heine University, 06/06/2008, ref: 3062 |
| Health condition(s) or problem(s) studied | Aneurysmal subarchnoid hemorrhage |
| Intervention | Concomitant intraventricular fibrinolysis (rt-PA) and low frequency rotational therapy for 48 hours, as compared to treatment as usal. Experimental therapy consists of intraventricular application of recombinant tissue plasminogen activator (rt-PA, Actilyse®, Boehringer Ingelheim, Germany) and low frequency rotational therapy (RotoRest®, KCI, NY, USA). Experimental therapy is initiated 6 hours, after obliteration of the ruptured aneurysm and unremarkable postinterventional CT scan, and conducted for 48 hours. For intraventricular fibrinolysis, 5 mg of rt-PA will be diluted in 2ml of NaCl and given as an intraventicular bolus every 12 hours over 48 hours via the external ventricular drain. After rt-PA bolus, the external ventricular drain will be locked and solely used to monitor intracranial pressure for 30 minutes to avoid premature drainage of the fibrinolytic agent. During the 48-hour period patients will remain sedated and intubated with concomitant lateral rotational therapy. Daily CT scanning will be performed until 2 days after cessation of rt-PA fibrinolysis to rule out hemorrhagic complications. Patients will be monitored for DCI using Perfusion-CT scanning. |
| Intervention type | Other |
| Primary outcome measure | Glasgow outcome score at discharge and after 6 weeks |
| Secondary outcome measures | 1. Clot clearance rate (CCR) between day 1 and day 5 after SAH ictus 2. Radiographic vasospasm between day 1 and day 15 after SAH ictus 3. New cerebral infarction on discharge CT or after death 4. Occurrence of posthemorrhagic hydrocephalus at discharge |
| Overall study start date | 01/12/2008 |
| Completion date | 30/09/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 60 |
| Key inclusion criteria | 1. Aneurysmal SAH (WFNS grade III-V) 2. Fisher grade II - IV 3. Patient age > 18 4. Admission less than 24 hours after ictus 5. No history for anticoagulative or antiaggregative agents 6. Informed consent by a legal representative |
| Key exclusion criteria | 1. Non-aneurysmal or Fisher ° 0-I SAH 2. Fusiform, mycotic or traumatic aneurysms 3. Pregnancy 4. Admission greater than 24 hours after ictus 5. History for severe cardiovascular disease 6. Clotting disorders 7. Platelet count less than 100,000, INR greater than 1.4 8. Ongoing internal bleeding |
| Date of first enrolment | 01/12/2008 |
| Date of final enrolment | 30/09/2011 |
Locations
Countries of recruitment
- Germany
Study participating centre
40225
Germany
Sponsor information
Hospital/treatment centre
c/o Prof. Dr Daniel Hänggi
Department of Neurosurgery
Moorenstr. 5
Düsseldorf
40225
Germany
| Website | http://www.uni-duesseldorf.de/ |
|---|---|
"ROR" |
https://ror.org/024z2rq82 |
Funders
Funder type
University/education
Government organisation / Local government
- Alternative name(s)
- Heinrich Heine University Düsseldorf, HHU
- Location
- Germany
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2013 | Yes | No |
Editorial Notes
26/05/2017: Plain English summary added.
