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IRCT20210509051232N1 IRCT 2021-08-06 Fasa University of Medical Sciences the effect of computed tomography without contrast in management of patients after moderate traumatic brain injury Study the effect of computed tomography without contrast in management of patients after moderate traumatic brain injury in a randomized clinical trial 2021-08-23 anticipated 72 Complete https://irct.ir/trial/57919 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Diagnostic, Randomization description: After generating a random sequence using random allocation software. Patients with eligibility conditions were selected by convenience sampling and randomly divided into groups with and without follow-up CT scans by randomized 4-way permutation blocks. It should be noted that the list prepared with tags will be kept secret for hiding. Patients are divided into intervention and control arms. N/A moderate traumatic brain injury. Intervention 1: Control group: Head CT scan without contrast routinely in all patients, In the control arm, a follow-up routine CT will be performed for all patients 6 hours after the initial CT scan. Also, all patients are admitted to the intensive care unit of neurosurgery and neurological examinations are performed every half an hour. Neurological examination includes Glasgow Coma Scale (GCS), pupil size, pupil light response, focal neurological deficit, vital signs, cerebral nerve examination 3, 4, 6, 10, and manual muscle test (MMT). Intervention 2: Intervention group: Head CT scan without contrast, if the doctor decides, based on the patient's clinical condition, In the intervention arm, patients will have a follow-up CT scan at 6 hours after the initial CT based on the occurrence of each of the following four cases: 1. Any change in the Glasgow Coma Scale (GCS) 2. Change of more than one millimeter in pupil size (one or two-sided) 3. Change in the reaction of one or two pupils to light 4. The appearance of any new focal neurological deficit. Also, all patients are admitted to the intensive care unit of neurosurgery and neurological examinations are performed every half an hour. Neurological examination includes Glasgow Coma Scale (GCS), pupil size, pupil light response, focal neurological deficit, vital signs, cerebral nerve examination 3, 4, 6, 10, and manual muscle test (MMT). Yes - There is a plan to make this available What will be shared: All data can be published after being unidentifiable When: Information will be available without a time limit To whom: Qualified persons according to the publisher's rules Conditions: For scientific use with detailed mention of the source Where to obtain: Refer to Publisher / Contact via the author's email address How to obtain: Information can be provided after correspondence via academic email Comments:
public Adrina Habibzadeh
Shahid rajai str, Shiraz
Shiraz Iran (Islamic Republic of) 7185935489 +98 71 3835 5957 Adrina.hbz77@gmail.com Fasa University of Medical Sciences scientific Adrina Habibzadeh
Shahid rajai str, Shiraz
Shiraz Iran (Islamic Republic of) 7185935489 +98 71 3835 5957 Adrina.hbz77@gmail.com Fasa University of Medical Sciences Iran (Islamic Republic of) The patient is in the first 6 hours after the onset of symptoms According to the PECARN criteria, the patient was taken without a brain contrast agent at the time of CT scan Glasgow Coma Score scale of the patient should be between 8 and 14 The patient is not a candidate for neurosurgical surgery The patient or his first-degree companion is willing to participate in the study consciously The patient is not a candidate for emergency surgery from another service The patient's vital signs are completely stable without the need for inotropic drugs The patient is not pregnant The patient does not have Anisocoria The patient has no seizures or no focal neurological deficit 19 years 95 years Both Glasgow Coma Score scale=3 and bilaterally fixed dilated pupils From the beginning of the study, the patient may experience a drop in GCS The need for neurosurgery or any other surgery at any time from the start of the study The unwillingness of the patient or his first-degree companions to participate in the study Lack of trust in the patient's neurological examination for any reason (psychologic cases, low compliance of the patient or companions, initiation of sedative drugs) Perform a brain CT scan for any reason earlier than 6 hours after the initial CT scan Previous use of anticoagulant drug S06.9 Unspecified intracranial injury Diagnosis Diagnosis Control group: Head CT scan without contrast routinely in all patients, In the control arm, a follow-up routine CT will be performed for all patients 6 hours after the initial CT scan. Also, all patients are admitted to the intensive care unit of neurosurgery and neurological examinations are performed every half an hour. Neurological examination includes Glasgow Coma Scale (GCS), pupil size, pupil light response, focal neurological deficit, vital signs, cerebral nerve examination 3, 4, 6, 10, and manual muscle test (MMT). Intervention group: Head CT scan without contrast, if the doctor decides, based on the patient's clinical condition, In the intervention arm, patients will have a follow-up CT scan at 6 hours after the initial CT based on the occurrence of each of the following four cases: 1. Any change in the Glasgow Coma Scale (GCS) 2. Change of more than one millimeter in pupil size (one or two-sided) 3. Change in the reaction of one or two pupils to light 4. The appearance of any new focal neurological deficit. Also, all patients are admitted to the intensive care unit of neurosurgery and neurological examinations are performed every half an hour. Neurological examination includes Glasgow Coma Scale (GCS), pupil size, pupil light response, focal neurological deficit, vital signs, cerebral nerve examination 3, 4, 6, 10, and manual muscle test (MMT). Need for surgical intervention. Timepoint: 6 hours and 30 day. Method of measurement: Patient file. Death. Timepoint: 6 hours and 30 days. Method of measurement: patient file. Length of hospital stay. Timepoint: 6 hours and 30 days. Method of measurement: patient file. Fasa University of Medical Sciences Approved 2021-08-03 Ethics committee of Fasa University of Medical Sciences Ebne Sina Square, Fasa Fasa Fars Iran (Islamic Republic of)