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Concomitant intraventricular fibrinolysis and low-frequency rotation after severe subarachnoid hemorrhage

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN13230264
Enrollment
60
Registered
2012-09-03
Start date
2008-12-01
Completion date
Unknown
Last updated
2017-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aneurysmal subarchnoid hemorrhage Circulatory System Subarachnoid haemorrhage

Interventions

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

Sponsors

Heinrich-Heine University (Germany)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Glasgow outcome score at discharge and after 6 weeks

Secondary

MeasureTime frame
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

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026