title: Prospective, randomized, open-label phase II trial on concomitant intraventricular fibrinolysis and low-frequency rotation after severe subarachnoid hemorrhage.
abstract: OBJECTIVE
  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 predominantly 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.
  
  
  BACKGROUND
  http://www.controlled-trials.com. Unique identifier: ICRCTN13230264.
authors.affiliation: Department of Neurosurgery and Institute for Diagnostic and Interventional Radiology, Medical Faculty, Heinrich-Heine-University, Düsseldorf, Germany.
authors.forename: Nima
authors.initials: N
authors.lastname: Etminan
authors.forename: Kerim
authors.initials: K
authors.lastname: Beseoglu
authors.forename: Sven Oliver
authors.initials: SO
authors.lastname: Eicker
authors.forename: Bernd
authors.initials: B
authors.lastname: Turowski
authors.forename: Hans-Jakob
authors.initials: HJ
authors.lastname: Steiger
authors.forename: Daniel
authors.initials: D
authors.lastname: Hänggi
mesh_terms: D000368:Aged; D002552:Cerebral Ventricles / Q000187:drug effects* / Q000601:surgery; D057510:Endovascular Procedures / Q000379:methods; D005081:Exercise Therapy / Q000379:methods*; D005260:Female; D005342:Fibrinolysis / Q000502:physiology; D005343:Fibrinolytic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D006257:Head / Q000502:physiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012399:Rotation; D012720:Severity of Illness Index; D013345:Subarachnoid Hemorrhage / Q000188:drug therapy / Q000628:therapy*; D015912:Thrombolytic Therapy / Q000009:adverse effects / Q000379:methods*; D010959:Tissue Plasminogen Activator / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D016896:Treatment Outcome
chemical_list: D005343:Fibrinolytic Agents; D010959:Tissue Plasminogen Activator
keywords: concomitant fibrinolysis and kinetic therapy; radiographic vasospasm; subarachnoid hemorrhage