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IRCT20180813040788N1 IRCT 2019-08-29 Esfahan University of Medical Sciences ICP Monitoring ICPmo Evaluation of effect of intracranial pressure monitoring catheter employment on prognosis of severe head trauma patient in Al Zahra hospital 2018-10-23 anticipated 40 Complete https://irct.ir/trial/39118 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: the patients were randomly allocated with proper statistics soft wares into two groups on patients. N/A Condition 1: Intracranial injury. Condition 2: Intracranial injury. Condition 3: Intracranial injury. Condition 4: Intracranial injury. Condition 5: Intracranial injury. Condition 6: Intracranial injury. Condition 7: Intracranial injury. Condition 8: Intracranial injury. Condition 9: Intracranial injury. Intervention 1: Intervention group: Patients in this group will receive intracranial pressure monitoring catheter (Spiegelberg probe 3PN) and intracranial pressure lowering treatments will be performed based on intracranial pressure value according to the study protocol. Intervention 2: Control group: In these patients intracranial pressure lowering treatments will be performed according to neurological examination and serial imaging according to the study protocol. Yes - There is a plan to make this available What will be shared: Data could be shared after Unidentifiable people. When: 6 months after publishing results To whom: Researchers working in academia Conditions: Via email at saeedmokhtari367@gmail.com Where to obtain: Via email at saeedmokhtari367@gmail.com How to obtain: After confirmation by the scientific team Comments:
public Saeed Sattaei Mokhtari
Sufeh Boulevard Al Zahra Medical Center
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 saeedmokhtari367@gmail.com Esfahan University of Medical Sciences scientific Saeed Sattaei Mokhtari
Sufeh Boulevard Al Zahra Medical Center
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 saeedmokhtari367@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients with consciousness levels of 3 to 8 (based on GCS criteria) and abnormal brain CT scans (including bleeding, cantogens, edema, brain hernia symptoms, or compression of brain cytars) that can be rescued, and patients with a level of consciousness 3 to 8 (based on GCS criteria) and normal brain CT scan older than 40 years of age, systolic blood pressure less than 90 mm Hg, or abnormal motor status in a clinical examination. no limit no limit Both Patients who are reluctant to continue studying are excluded. S06.0 S06.1 S06.2 S06.3 S06.4 S06.5 S06.6 S06.8 S06.9 Concussion Traumatic cerebral edema Diffuse traumatic brain injury Focal traumatic brain injury Epidural hemorrhage Traumatic subdural hemorrhage Traumatic subarachnoid hemorrhage Other specified intracranial injuries Unspecified intracranial injury Early detection Early detection Intervention group: Patients in this group will receive intracranial pressure monitoring catheter (Spiegelberg probe 3PN) and intracranial pressure lowering treatments will be performed based on intracranial pressure value according to the study protocol. Control group: In these patients intracranial pressure lowering treatments will be performed according to neurological examination and serial imaging according to the study protocol. Prognosis of patients with severe brain trauma. Timepoint: Determination of prognosis of patients with severe traumatic brain injury on discharge. Method of measurement: The Glasgow Outcome Scale Extended (GOS-E). Surgical site infection. Timepoint: During the hospitalization. Method of measurement: Clinical signs and symptoms and Cultivation of the wound site. Meningitis. Timepoint: During the hospitalization. Method of measurement: Clinical signs and symptoms and cerebrospinal fluid culture. Esfahan University of Medical Sciences Approved 2017-12-23 Ethics Committee of Isfahan University of Medical Sciences Hezar Jerib Avenue Isfahan University of Medical Sciences Isfahan Isfehan Iran (Islamic Republic of)