TY - CHAP
T1 - Preliminary report of the clot lysis evaluating accelerated resolution of intraventricular hemorrhage (CLEAR-IVH) clinical trial
AU - Morgan, T.
AU - Awad, I.
AU - Keyl, P.
AU - Lane, Karen
AU - Hanley, Daniel F
PY - 2008/1/1
Y1 - 2008/1/1
N2 - Introduction. Brain hemorrhage is the most frequent fatal form of stroke and has the highest level of morbidity of any stroke subtype. For patients with both intracerebral hemorrhage and intraventricular hemorrhage (IVH), expected mortality is 50-80%. No validated, efficacious treatment exists for humans, but animal models demonstrate substantial physiologic and functional benefits associated with rapid, near-complete removal of blood from either the ventricle or intracerebral location (i.e., ~80% removal over 48 h). The purpose of the CLEAR-IVH trial (Parts A and B) is to evaluate safety and efficacy of using multiple injections of low-dose rt-PA to accelerate lysis and evacuation of IVH. Methods. Patients enrolled in the trial receive an injection of 1.0mg rt-PA through an external ventricular drain every 8 h up to 12 doses, or until clot reduction or clinical endpoint is met. CT scans are taken daily to monitor clot resolution and check for unexpected bleeding events. In a previous dose-finding study where the safety profile (symptomatic re-bleeding) was 0%, 1 mg rt-PA every 8 h was determined the appropriate dose. Results. Comprehensive analyses of 36 patients in the recently completed CLEAR-IVH Part B are currently being conducted. Adverse events are within safety limits, including 30-day mortality, 8%; symptomatic re-bleeding, 8%; and bacterial ventriculitis, 0%. Conclusion. Preliminary analyses show that use of low-dose rt-PA can be safely administered to stable IVH clots and may increase lysis rates.
AB - Introduction. Brain hemorrhage is the most frequent fatal form of stroke and has the highest level of morbidity of any stroke subtype. For patients with both intracerebral hemorrhage and intraventricular hemorrhage (IVH), expected mortality is 50-80%. No validated, efficacious treatment exists for humans, but animal models demonstrate substantial physiologic and functional benefits associated with rapid, near-complete removal of blood from either the ventricle or intracerebral location (i.e., ~80% removal over 48 h). The purpose of the CLEAR-IVH trial (Parts A and B) is to evaluate safety and efficacy of using multiple injections of low-dose rt-PA to accelerate lysis and evacuation of IVH. Methods. Patients enrolled in the trial receive an injection of 1.0mg rt-PA through an external ventricular drain every 8 h up to 12 doses, or until clot reduction or clinical endpoint is met. CT scans are taken daily to monitor clot resolution and check for unexpected bleeding events. In a previous dose-finding study where the safety profile (symptomatic re-bleeding) was 0%, 1 mg rt-PA every 8 h was determined the appropriate dose. Results. Comprehensive analyses of 36 patients in the recently completed CLEAR-IVH Part B are currently being conducted. Adverse events are within safety limits, including 30-day mortality, 8%; symptomatic re-bleeding, 8%; and bacterial ventriculitis, 0%. Conclusion. Preliminary analyses show that use of low-dose rt-PA can be safely administered to stable IVH clots and may increase lysis rates.
KW - Intraventricular hemorrhage
KW - thrombolysis
KW - tissue plas-minogen activator.
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U2 - 10.1007/978-3-211-09469-3_41
DO - 10.1007/978-3-211-09469-3_41
M3 - Chapter
C2 - 19066112
AN - SCOPUS:85052608569
SN - 9783211094686
T3 - Acta Neurochirurgica, Supplementum
SP - 217
EP - 220
BT - Cerebral Hemorrhage
PB - Springer-Verlag Wien
ER -