Preliminary report of the clot lysis evaluating accelerated resolution of intraventricular hemorrhage (CLEAR-IVH) clinical trial
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.
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.
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%.
Preliminary analyses show that use of low-dose rt-PA can be safely administered to stable IVH clots and may increase lysis rates.
KeywordsIntraventricular hemorrhage thrombolysis tissue plas-minogen activator.
Unable to display preview. Download preview PDF.
- 1.Adams HP, Torner JC, Kassell NF (1992) Intraventricular hemorrhage among patients with recently ruptured aneurysms: a report of the Cooperative Aneurysm Study. Stroke 23: 140 (abstract)Google Scholar
- 4.Bagley C (1928) Blood in cerebrospinal fluid. Resultant functional and organic alterations in the central nervous system. Arch Surg 17: 39–81Google Scholar
- 7.Conway JE, Oshiro EM, Piantadosi S (1998) Ventricular blood is an admission ct variable which predicts poor clinical outcome after aneurysmal subarachnoid hemorrhage. American Association of Neurological Surgeons Annual Meeting, Philadelphia, PA. J Neurosurg 88: 398A (abstract)Google Scholar