Condition category
Circulatory System
Date applied
18/07/2012
Date assigned
03/09/2012
Last edited
27/09/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Lay summary under review 3

Trial website

Contact information

Type

Scientific

Primary contact

Prof Daniel Hänggi

ORCID ID

Contact details

Department of Neurosurgery
Heinrich-Heine University
Moorenstr. 5
Düsseldorf
40225
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Study ID: 3062

Study information

Scientific title

Prospective, randomized, phase II-b trial on concomitant intraventricular fibrinolysis and low-frequency rotation after severe subarachnoid hemorrhage

Acronym

Study hypothesis

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

Local Institutional Ethics Committee of the Medical Faculty of Heinrich-Heine University, Düssedlorf, Germanym, 06 June 2008, ref: 3062

Study design

Sincle-center randomized controlled phase II-b study with blinded outcome analysis

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Phase II

Drug names

Primary outcome measures

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 trial start date

01/12/2008

Overall trial end date

30/09/2011

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60

Participant 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

Recruitment start date

01/12/2008

Recruitment end date

30/09/2011

Locations

Countries of recruitment

Germany

Trial participating centre

Department of Neurosurgery
Düsseldorf
40225
Germany

Sponsor information

Organisation

Heinrich-Heine University (Germany)

Sponsor details

c/o Prof. Dr. Daniel Hänggi
Department of Neurosurgery
Moorenstr. 5
Düsseldorf
40225
Germany

Sponsor type

Hospital/treatment centre

Website

http://www.uni-duesseldorf.de/

Funders

Funder type

University/education

Funder name

University of Düsseldorf (Germany)

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

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23735957

Publication citations

  1. Results

    Etminan N, Beseoglu K, Eicker SO, Turowski B, Steiger HJ, Hänggi D, Prospective, randomized, open-label phase II trial on concomitant intraventricular fibrinolysis and low-frequency rotation after severe subarachnoid hemorrhage., Stroke, 2013, 44, 8, 2162-2168, doi: 10.1161/STROKEAHA.113.001790.

Additional files

Editorial Notes