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Subarachnoid Hemorrhage clinical trials

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NCT ID: NCT05003232 Not yet recruiting - Clinical trials for Optimal Cerebral Perfusion Pressure on the Outcome of aSAH Patients

NIRS Directed Optimal Cerebral Perfusion Pressure on the Outcome of Aneurysmal Subarachnoid Hemorrhage Patients

Start date: September 1, 2021
Phase: N/A
Study type: Interventional

Objectives: To investigate the impact of NIRS directed optimal cerebral perfusion pressure on the outcome of aSAH patients. Study design: A multicenter, single-blinded, randomized controlled trial. Setting: Departments of critical care medicine of tertiary hospitals in China. Patients: 150 aSAH patients (≥ 18 years old) who admitted to ICU (predicted ICU duration time ≥ 24 hours) Intervention: Patients with aSAH will be randomly divided into the control group and the intervention group. The control group will follow the SAH guidelines. The intervention group will be given continuous NIRS and invasive blood pressure monitoring at same time. The correlation curve between the brain oxygenation index or the brain hemoglobin index (ORI/THx) and the blood pressure will be obtained through continuous monitoring. According to the correlation curve, the optimal blood pressure will be determined which provides the optimal CPP. Then the goal of blood pressure (within 5 mmHg of CPPopt) will be maintained as the target of blood pressure management for the intervention group during ICU stay. Primary outcome: Neurological prognosis (GCS score,GOS score, and NIHSS score when discharge from ICU; GOS score at 6 months), etc. Predicted duration of the study: 2 years.

NCT ID: NCT04728438 Not yet recruiting - Sepsis Clinical Trials

Effect of Targeted Temperature Management on Cerebral Autoregulation in Patients With Neurocritical Diseases

Start date: January 22, 2021
Phase:
Study type: Observational

Change and effect of cerebral autoregulation during targeted temperature management in neurocritical patients

NCT ID: NCT04696523 Not yet recruiting - Cerebral Infarction Clinical Trials

Effect of Xenon on Brain Injury After Aneurysmal Subarachnoid Hemorrhage

Xe-SAH
Start date: October 1, 2023
Phase: Phase 2
Study type: Interventional

An investigator-initiated clinical drug study Main Objective: To explore neuroprotective properties of xenon in patients after aneurysmal subarachnoid hemorrhage (SAH). Primary endpoint: Global fractional anisotropy of white matter of diffusion tensor imaging (DTI). Hypothesis: White matter damage is less severe in xenon treated patients, i.e. global fractional anisotropy is significantly higher in the xenon group than in the control group as assessed with the 1st magnetic resonance imaging (MRI). After confirmation of aSAH and obtaining a signed assent subjects will be randomized to the following groups: Control group: Standard of Care (SOC) group: Air/oxygen and Normothermia 36.5-37.5°C; Xenon group: Normothermia 36.5-37.5°C +Xenon inhalation in air/oxygen for 24 hours. Brain magnetic resonance imaging techniques will be undertaken to evaluate the effects of the intervention on white and grey matter damage and neuronal loss. Neurological outcome will be evaluated at 3, 12 and 24 months after onset of aSAH symptoms Investigational drug/treatment, dose and mode of administration: 50±2 % end tidal concentration of inhaled xenon in oxygen/air. Comparative drug(s)/placebo/treatment, dose and mode of administration: Standard of care treatment according to local and international consensus reports. Duration of treatment: 24 hours Assessments: Baseline data Information that characterizes the participant's condition prior to initiation of experimental treatment is obtained as soon as is clinically reasonable. These include participant demographics, medical history, vital signs, oxygen saturation, and concentration of oxygen administered. Acute data The collected information will contain quantitative and qualitative data of aSAH patients, as recommended by recent recommendations of the working group on subject characteristics, and including all relevant Common Data Elements (CDE) can be applied. Specific definitions, measurements tools, and references regarding each SAH CDE can be found on the weblink here: https://www.commondataelements.ninds.nih.gov/SAH.aspx#tab=Data_Standards.

NCT ID: NCT04613960 Not yet recruiting - Clinical trials for Subarachnoid Hemorrhage, Aneurysmal

Magnesium Treating Subarachnoid Hemorrhage Vasospasm

MATSH-SHapE
Start date: December 2022
Phase: Phase 2/Phase 3
Study type: Interventional

A randomized clinical trial investigating magnesium sulphate ability to reduce risk of cerebral vasospasm after acute subarachnoid hemorrhage hence improving outcome particularly in haptoglobin 2-2 patients who are highly susceptible for severe complications after subarachnoid hemorrhage.

NCT ID: NCT04532333 Not yet recruiting - Clinical trials for Subarachnoid Hemorrhage, Aneurysmal

Efficacy and Safety of Bivalirudin Versus Heparin During Coil Embolization in Patients With Ruptured Intracranial Aneurysms

BUILD
Start date: August 2020
Phase: Phase 3
Study type: Interventional

This is a randomized, open label, multi-center, positive-controlled study, in which a total of 236 patients will be enrolled and randomly assigned to receive bivalirudin or heparin in a 1:1 ratio during coil embolization in patients with ruptured intracranial aneurysms. Procedure-related complication, mRS, Activated Clotting Time, ischemic and hemorrhagic complications, symptomatic and asymptomatic intracranial hemorrhage, death, Heparin Induced Thrombocytopenia will be evaluated during procedure, at 24hs, 7days and 30 days after.

NCT ID: NCT04512859 Not yet recruiting - Clinical trials for Subarachnoid Hemorrhage, Aneurysmal

Stellate Ganglion Block in Preventing Cerebral Vasospasm Secondary to Subarachnoid Hemorrhage

Start date: September 1, 2020
Phase: N/A
Study type: Interventional

To investigate whether the stellate ganglion block is helpful in relieving cerebral vasospasm during aneurysmal coil embolism surgery. The effect was assessed by Transcranial Doppler (TCD).

NCT ID: NCT04177329 Not yet recruiting - Clinical trials for Subarachnoid Hemorrhage

Impact of Cardiac Complications on Outcomes of Patients After Subarachnoid Hemorrhage

Start date: December 1, 2019
Phase:
Study type: Observational

Patients with subarachnoid haemorrhage frequently develop cardiac complications affecting their outcome

NCT ID: NCT03879330 Not yet recruiting - Clinical trials for The Time for Determine CPPopt

NIRS Directed Optimal Cerebral Perfusion Pressure in Aneurysmal Subarachnoid Hemorrhage Patients: A Feasibility Study

Start date: July 1, 2019
Phase:
Study type: Observational

Neurologic dysfunction is common in aneurysmal subarachnoid hemorrhage (aSAH) patients. As we know, after the initial injury, secondary insults including poor cerebral perfusion are main contributors to poor outcome and their early detection and amelioration are keystone to neurocritical care. Nonetheless, the guidelines for blood pressure management still recommend a single target blood pressure for critically ill patients: the Brain Trauma Foundation (BTF) guidelines recommend maintaining CPP between 60 and 70 mmHg; Some guidelines recognize that patients with a history of hypertension may require a higher MAP. However, these guidelines do not currently recommend cerebral autoregulation-guided therapy and leave many unanswered questions. Cerebral autoregulation is the mechanism that maintains cerebral blood supply, hence CBF approximately constant despite changes in MAP or, more precisely, despite changes in CPP. Maintaining blood pressure within the cerebral blood flow (CBF) autoregulation range (termed "optimal MAP") is associated with improved outcomes for patients. The observational data suggests that management of patients above or below CPPopt 5mmHg is associated with better outcomes and mortality than the other greater variation range. The most commonly used method for monitoring dynamic cerebrovascular reactivity is the pressure reactivity index (PRx) that uses ICP as a surrogate for CBV. However, assessing the PRx requires invasive ICP monitoring which limits its application in many clinical areas. Alternatively, in the absence of invasive intracranial pressure monitoring to determine CPP, a continuous autoregulation monitoring can be accomplished by the continuous correlation between transcranial Doppler (TCD)-measured CBF velocity of the middle cerebral artery and the mean arterial blood pressure (termed mean velocity index or Mx). Mx is a validated index of cerebral autoregulation based on measures of cerebral perfusion pressure and mean flow velocity on transcranial doppler but is impractical for longer-term monitoring and requires system training, the results are operator-dependent. Near-infrared spectroscopy (NIRS) measurements is another alternative for real-time autoregulation monitoring in the form of a Tissue Oxygenation Index. In contrast to TCD, the NIRS sensors are very easy to apply (the probes attach to the forehead with self-adhesive pads) and do not require frequent calibration making them more suitable for long-term monitoring. Therefore, in this study, Patients in the intervention group will be monitored by continuous NIRS and invasive blood pressure monitoring. The correlation curve between ORI/THx and blood pressure will be obtained through continuous monitoring of 2 hours. According to the correlation curve, the optimal blood pressure which provides the optimal CPP will be determined. Then the optimal blood pressure which CPP is within 5 mmHg of CPPopt will be maintained as the target of blood pressure management for the intervention group during ICU stay.

NCT ID: NCT03745456 Not yet recruiting - Clinical trials for Subarachnoid Hemorrhage

Hemostasis Profile in Patients With Severe Subarachnoid Hemorrhage

Start date: December 1, 2018
Phase:
Study type: Observational

Patients with severe subarachnoid hemorrhage (SAH) may present platelet and coagulation dysfunctions immediately after the stroke on admission at the hospital, and persisting up to 3-4 weeks after the onset. This study aimed to investigate the platelet function as assessed by impedance agregometry (ROTEM Platelet) and platelet adhesion (PFA), and the coagulation profile as assessed by ROTEM, over three evolutive times.

NCT ID: NCT03442608 Not yet recruiting - Hypothermia Clinical Trials

Trial of Long-term Therapeutic Hypothermia for Poor-grade Aneurysmal Subarachnoid Hemorrhage

Start date: March 1, 2018
Phase: N/A
Study type: Interventional

This study is a prospective, multi-centre, randomized,controlled trial to compare the efficacy of long-term mild hypothermia with normothermic intensive management in patients with poor-grade aneurysmal subarachnoid hemorrhage. The primary hypothesis is that the induction of mild hypothermia (maintained at 32-35℃) for at least 5 days would improve the outcome of patients at six months post hemorrhage compared with normothermia.