Spontaneous subarachnoid haemorrhage.
R Loch Macdonald, Tom A Schweizer
https://pubmed.ncbi.nlm.nih.gov/27637674Actively Recruiting
Led by Huashan Hospital · Updated on 2025-01-07
372
Participants Needed
1
Research Sites
136 weeks
Total Duration
Researchers are investigating the use of intracranial pressure (ICP) monitoring to improve outcomes for patients who have experienced aneurysmal subarachnoid hemorrhage (aSAH), a serious type of brain bleeding caused by ruptured aneurysms. This condition has high rates of death and disability, and increased ICP after aSAH is common and associated with worse neurological function. The trial aims to provide high-level evidence on whether managing ICP through intraventricular monitoring can enhance patient prognosis. The study compares treatment guided by intraventricular ICP monitoring to standard care. Patients undergo craniotomy clipping or endovascular treatment within 72 hours to address the bleeding aneurysm. For those in the ICP monitoring group, postoperative management is directed by the precise ICP measurements obtained, while other treatments remain consistent with the control group. This approach allows real-time assessment and control of brain pressure. Participants are assessed through clinical evaluations, imaging, and monitoring of neurological function over time, with the primary outcome being the rate of good neurological recovery 90 days after treatment. Consent is obtained from patients and their families before enrollment. The study is prospective, multicenter, randomized, and controlled, focusing on adults with specific grades of aSAH and symptom onset within 72 hours, with safety and efficacy closely monitored throughout the trial.
CONDITIONS
aSAH Treatment Based on Intraventricular ICP Monitoring: A Prospective, Multicenter, Randomized and Controlled Trial
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Total: 1 location
1
Department of Neurosurgery, Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
X
Xuehai Wu, Ph.D.
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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