CLINICAL TRIAL, PHASE III
CONTROLLED CLINICAL TRIAL
JOURNAL ARTICLE
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The effect of lumboventricular lavage and simultaneous low-frequency head-motion therapy after severe subarachnoid hemorrhage: results of a single center prospective Phase II trial.

OBJECT: The authors of recent publications have suggested that a combination of cisternal irrigation and head-shaking therapy might reduce cerebral vasospasm after subarachnoid hemorrhage (SAH) and therefore improve outcome. The authors undertook this prospective nonrandomized Phase II study to analyze the effect of enhanced washout by lumboventricular irrigation in combination with head motion (lateral rotational therapy) on the clot clearance (CC) rate, development of cerebral vasospasm, and clinical outcome.

METHODS: Forty patients with aneurysmal SAHs of World Federation of Neurosurgical Societies Grades II-V (Glasgow Coma Scale Scores 13-3) and Fisher Grade 3 or 4 were included in this study. The study and control groups each consisted of 20 patients. The protocol in the study group, after the aneurysm was secured and a ventricular drain inserted, included the insertion of 2 lumbar catheters for intrathecal irrigation with Ringer solution and intrathecal pressure monitoring. Moderate head rotation in a kinetic system was also applied and was continued for 5 days. The CC rate was monitored on daily computed tomography (CT) scans. Vasospasms were identified clinically with a focus on delayed ischemic neurological deficits (DINDs), daily transcranial Doppler (TCD) ultrasonography studies, and analysis of infarction rate on CT and cerebral angiography. The data obtained in both groups were statistically evaluated.

RESULTS: There were no procedure-related complications. The overall CC rate did not differ significantly between the groups, but there was a trend toward accelerated resolution in the study group. During observation, a new neurological deficit developed in 1 patient (5%) in the study group and 4 patients (20%) in the control group. Ischemic areas on CT scans related to vasospasm were demonstrated in 2 patients (10%) in the study group and 6 patients (30%) in the control group. The incidence of angiographic vasospasm was approximately the same in both groups. The pooled TCD flow velocities measured over a period of 14 days showed lower mean values in the study group than in the control group (p = 0.00002). The clinical outcome in the study group as evaluated with the modified Rankin scale was better in the study group than in the control group after 3 (p = 0.008) and 6 (p = 0.005) months.

CONCLUSIONS: The present study demonstrates that a combination of lumboventricular lavage and mechanical head motion reduces vasospasm on TCD ultrasonography, the incidence of DIND, and secondary infarctions on CT and improves clinical outcome. No obvious effect could be found on the rate of angiographic vasospasm.

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