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NCT04143347 · ClinicalTrials.gov registry record
Outcome of Patients With Mild Head Injury and Presence of an Acute Traumatic Abnormality on CT Scan of Head
A clinical trial, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- 192
- Enrollment target
NCT04143347: Completed study, sponsored by Massachusetts General Hospital.
NCT04143347 is a clinical trial that has completed, run by Massachusetts General Hospital. The registered enrollment target is 192 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04143347 has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- 192 participants
- Enrollment target
Study Summary
Background: Patients with mild blunt traumatic brain injury (TBI) are frequently transferred to Level 1 trauma centers (L1TC) if they have any positive finding of any acute intracranial injury identified on a CT scan of the head. The hypothesis for the study is that patients with such injuries and minor changes on the Head CT scan can be safely managed at community hospitals (CH). Methods: Patients with blunt, mild TBI (defined as a GCS 13-15 at presentation) presenting to CH, L1TC, and transferred from CH to L1TC between March, 2012 and February, 2014 were included. Minor changes on head CT were defined as: 1) epidural hematoma\<2mm; 2) subarachnoid hemorrhage\<2mm; 3) subdural hematoma\<4mm; 4) intraparenchymal hemorrhage\<5mm; 5) minor pneumocephalus; or 6) linear or minimally depressed skull fracture. TBI-specific interventions were defined as intracranial pressure monitor placement, administration of hyperosmolar therapy, or neurosurgical operation. Three groups of patients were compared: 1) those receiving treatment at CH, 2) those transferred from CH to L1TC, and 3) those presenting directly to L1TC. The primary endpoint was the need for TBI-specific intervention and secondary outcome was death of any patient.
Primary Outcome
1. Patients requiring Hyperosmolar therapy - either mannitol or hypertonic saline. 2. Neurosurgical operation 3. Insertion of an Intracranial pressure monitor
Interventions
- OTHER No Intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 192 participants |
| Start Date | 2012-03-01 |
| Est. Completion | 2014-05-01 |
What the finished NCT04143347 record still lists
NCT04143347 is an observational study that tracks outcomes without assigning an intervention. The registered 192 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which No Intervention is the first listed.
NCT04143347 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04143347 about?
NCT04143347 is a clinical study titled "Outcome of Patients With Mild Head Injury and Presence of an Acute Traumatic Abnormality on CT Scan of Head". Background: Patients with mild blunt traumatic brain injury (TBI) are frequently transferred to Level 1 trauma centers (L1TC) if they have any positive finding of any acute intracranial injury identified on a CT scan of the head. The hypothesis for the study is that patients with such injuries and m...
What is the current status of trial NCT04143347?
This trial is currently completed. The enrollment target is 192 participants. The study started on 2012-03-01. Estimated completion is 2014-05-01.
What interventions are being tested in trial NCT04143347?
The interventions under investigation include: No Intervention (OTHER).
Who is sponsoring clinical trial NCT04143347?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
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