Prospective, Randomized, Open-Label Phase II Trial on Concomitant Intraventricular Fibrinolysis and Low-Frequency Rotation After Severe Subarachnoid Hemorrhage
Background and Purpose—The goal of this randomized, open-label phase II study was to investigate the effect of concomitant low-frequency head-motion therapy and intraventricular fibrinolysis in patients after surgical or endovascular treatment for aneurysmal subarachnoid hemorrhage.
Methods—Sixty patients experiencing subarachnoid hemorrhage were randomized into treatment with intraventricular application of recombinant tissue-type plasminogen activator and lateral rotational therapy (experimental) or treatment as usual (control). The primary end point was defined as functional outcome, measured by Glasgow Outcome Scale at discharge and at 3-month follow-up. Clot clearance rate, radiographic features of delayed cerebral ischemia, and posthemorrhagic hydrocephalus were defined as secondary end points.
Results—The majority of patients (78.3%) experienced severe subarachnoid hemorrhage. Although there was a higher incidence of subgaleal hematomas in the experimental group, there was no difference in the incidence of adverse or severe adverse events between the 2 groups. Despite significantly higher clot clearance rates, there was no beneficial effect on the incidence of delayed cerebral ischemia and poor functional outcome, as well as posthemorrhagic hydrocephalus after experimental treatment.
Conclusions—Despite the ineffectiveness on reduction of delayed cerebral ischemia or poor functional outcome, intraventricular fibrinolysis and kinetic therapy seems to be a safe and effective concept for therapeutic reduction of subarachnoid clot in a patient collective experiencing predominately severe subarachnoid hemorrhage. Therefore, future studies should investigate this treatment in a larger patient collective with a lower degree of primary brain injury and until full clot clearance on serial imaging.
Clinical Trial Registration—URL: http://www.controlled-trials.com. Unique identifier: ICRCTN13230264.
- Received April 13, 2013.
- Revision received April 25, 2013.
- Accepted May 6, 2013.
- © 2013 American Heart Association, Inc.