Stroke and Neurotrauma analyzed by CSD and temperature under monitoring

JRCT ID: jRCTs062190011

Registered date:10/07/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Subarachnoid hemorrhage ,severe cerebral infarction , severe head trauma , severe cerebral hemorrha
• Date of first enrollment: 15/11/2019
• Target sample size: 50
• Study type: Interventional

Intervention(s)

1)Placement of subdural electrodes or multimodal sensor
1.After confirmation of inclusion criteria and informed consent for the patients with subarachnoid hemorrhage (SAH),the subdural electrodes or the multimodal sensor is implanted at the time of clipping craniotomy. The neurophysiological monitoring is performed for 14 days from the onset. For the patients with severe grade 5 SAH, endovascular coil embolization with burr hole surgery is performed. At the surgery, subdural electrode is implanted for neurophysiological monitoring 14 days.
2.After confirmation of inclusion criteria and informed consent for the patients with severe cerebral infarction, the subdural electrodes or the multimodal sensor is implanted at the time of decompressive craniectomy, and neurophysiological monitoring is performed for 7 days from the onset.
3.After confirmation of inclusion criteria and informed consent for the patients with severe neurotrauma, the subdural electrodes or the multimodal sensor is implanted at the time of decompressive craniectomy, and neurophysiological monitoring is performed for 7 days from the onset.
4.After confirmation of inclusion criteria and informed consent for the patients with severe cerebral hemorrhage, the subdural electrodes or the multimodal sensor is implanted at the time of decompressive craniectomy, and neurophysiological monitoring is performed for 7 days from the onset.
2)Sampling of CSF
CSF is obtained through the drainage, and stored at -20 degrees.Thereafter, concentration of potassium is measured.
3)Removal of the subdural electrode and multimodal sensor. The electrodes and the multimodal sensor is removed without opening of the surgical wound again.

Outcome(s)

• Primary Outcome: Frequency of appearance and duration of the spreading depolarization. Neurological outcome of the patients 30 days and 180 days after the onset, assessed by mRS and GOS
• Secondary Outcome: Assessment of the safety and worsening sign in the blood and neuroradiological examinations. Changes in cerebral blood flow and brain temperature during the occurrence of the spreading depolarization will be analyzed for investigation of the pathophysiology.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1)Man or woman patients aged 20 years or more
2)Patients who admitted Yamaguchi University Hospital
3)Patients who received sufficient information and understand on the inclusion. Patients or family member agreed to join the research under free will.
4)Patients with the following diseases
1.Patients with SAH going to be operated with aneurysmal surgery by 3 days from the onset.
2.Patients with severe cerebral infarction going to be operated with decompressive craniectomy by 48h from the onset.
3.Patients with severe neurotrauma with GCS 8 or less, going to be operated with decompressive craniectomy.
4.Patients with cerebral hemorrhage going to be operated because of brain swelling or large hemorrhage.

Exclude criteria

1)Patients suspected immunodeficiency due to steroids or immunosuppressing agents
2)Patients whom the research leader decides not to optimal to include the study.

Related Information

• Primary Sponsor: Nomura Sadahiro
• Secondary Sponsor: Suzuki Michiyasu