Prospective, randomized, open-label phase II trial on concomitant intraventricular fibrinolysis and low-frequency rotation after severe subarachnoid hemorrhage
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Prospective, randomized, open-label phase II trial on concomitant intraventricular fibrinolysis and low-frequency rotation after severe subarachnoid hemorrhage. / Etminan, Nima; Beseoglu, Kerim; Eicker, Sven Oliver; Turowski, Bernd; Steiger, Hans-Jakob; Hänggi, Daniel.
In: STROKE, Vol. 44, No. 8, 08.2013, p. 2162-8.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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T1 - Prospective, randomized, open-label phase II trial on concomitant intraventricular fibrinolysis and low-frequency rotation after severe subarachnoid hemorrhage
AU - Etminan, Nima
AU - Beseoglu, Kerim
AU - Eicker, Sven Oliver
AU - Turowski, Bernd
AU - Steiger, Hans-Jakob
AU - Hänggi, Daniel
PY - 2013/8
Y1 - 2013/8
N2 - 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 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.CLINICAL TRIAL REGISTRATION URL: http://www.controlled-trials.com. Unique identifier: ICRCTN13230264.
AB - 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 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.CLINICAL TRIAL REGISTRATION URL: http://www.controlled-trials.com. Unique identifier: ICRCTN13230264.
KW - Aged
KW - Cerebral Ventricles
KW - Endovascular Procedures
KW - Exercise Therapy
KW - Female
KW - Fibrinolysis
KW - Fibrinolytic Agents
KW - Head
KW - Humans
KW - Male
KW - Middle Aged
KW - Prospective Studies
KW - Rotation
KW - Severity of Illness Index
KW - Subarachnoid Hemorrhage
KW - Thrombolytic Therapy
KW - Tissue Plasminogen Activator
KW - Treatment Outcome
U2 - 10.1161/STROKEAHA.113.001790
DO - 10.1161/STROKEAHA.113.001790
M3 - SCORING: Journal article
C2 - 23735957
VL - 44
SP - 2162
EP - 2168
JO - STROKE
JF - STROKE
SN - 0039-2499
IS - 8
ER -