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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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20210509051232N1
Enrollment
72
Registered
2021-08-06
Start date
2021-08-23
Completion date
Unknown
Last updated
2021-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

moderate traumatic brain injury. Unspecified intracranial injury

Interventions

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.

Sponsors

Fasa University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
19 Years to 95 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Need for surgical intervention. Timepoint: 6 hours and 30 day. Method of measurement: Patient file.

Secondary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAdrina Habibzadeh

Fasa University of Medical Sciences

Adrina.hbz77@gmail.com+98 71 3835 5957

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026