Injuries and WoundsNCT00424736
the Role of Total Body Imaging in Asymptomatic Pediatric Trauma Patients
An observational study of Injuries and Wounds, run by Assaf-Harofeh Medical Center.
Trial summary
Whole body imaging has no role in asymptomatic pediatric trauma patients Read more about this study
- Who is it for?
- Ages 1 month to 15 years
- Conditions the study is for
- Injuries and Wounds
- What is being tested?
- whole body CT scan
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jan 2007to Jan 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All asymptomatic trauma patients from 0 to 15 years old
Who cannot join
- Any pediatric trauma patients with clinical indications for CT scan
About this study
Official title: Role of Whole Body Imaging in Asymptomatic Pediatric Trauma Patients
Whole body imaging has no role in asymptomatic pediatric trauma patients
Read the detailed description
Negative physical examination alone has been shown unreliable for excluding intra-abdominal injuries in adult patients with multitrauma. Therefore, the management of patients with a normal clinical examination after blunt trauma is a subject of controversy. Since 1970s, computer tomography (CT) has become the mainstay of evaluating hemodynamically stable trauma patients. It's generally accepted that hemodynamically stable patient with abnormal abdominal examination results require the use of CT as well as patients with depressed level of consciousness. Controversy exists with the awake, clinically evaluable patients with no obvious signs of abdominal and chest trauma. In the last years number of studies express CT role in evaluation of asymptomatic trauma patient with mechanism of injury supporting probability of internal organs injury. Those studies show that in a large number of patients the management was changed according to CT results. The authors recommended liberal use of CT in trauma patient population. All those studies have been performed in adult trauma patients. The purpose of this study is to evaluate the role of whole body imaging in pediatric patients with suspicious mechanism of injury, which are hemodynamically stable and has no obvious signs of chest and abdominal injury. The incidence of injury in these patient population as well as changes in treatment based on results of CT will be examined. Methods The prospective observational study will be performed in Assaf Harofeh Medical Center. All patients up to 15 years old with blunt mechanism of multisystem trauma will be eligible for enrollment to the study. Only patients whose parents singed the inform consent will be enrolled.Inclusion criteria will be based on the mechanism of injury: 1. no visible injury of chest and abdomen2. hemodynamically stable3. normal abdominal examination in neurologically intact patient or unevaluable abdominal examination in patients with depressed level of consciousness. 4. significant mechanism of injury as any of the following a. high speed (more than 55km/hr) motor vehicle accident b. fall of greater than 3 meters c. automobile hitting pedestrian d. assaulted with depressed level of consciousness All patients will undergo CT of the head, chest, abdomen and pelvis as a part of their evaluation. CT scan will be performed in Emergency Department short after patient's admission and clinical evaluation. An abnormal CT will be defined as exhibiting any traumatic abnormality. Patient treatment plan changes will be defined as alteration in management based directly on CT findings.Data regarding patient demographics, mechanism of injury, physical examination findings, Glasgow Coma Score on emergency department admission, Injury Severity Score, radiologic interpretation of chest and pelvic roentgenograms, injuries required operative procedures, laboratory data, CT scan findings, and changes in management plan based on CT findings will be recorded.
- Conditions
- Injuries and Wounds
- Being tested
- whole body CT scan
- Keywords
- blunt trauma, pediatric patient, imaging, computer tomography
- Medical subject headings
- Wounds and Injuries, Wounds, Nonpenetrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
whole body CT scanProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2007 (estimated)
- Study startJan 2007
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Injuries and WoundsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Prospective
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Investigators
- Igor Jeroukhimov, MD, Principal investigator, Assaf-Harofeh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00424736
- Sponsor's protocol ID
- igorjer1
- Status last verified
- Jan 2007
- First submitted
- 16 Jan 2007
- Last updated
- 19 Jan 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Whole Body Imaging in Asymptomatic Pediatric Trauma Patients
- ClinicalTrials.gov ID
- NCT00424736
- Acronym / sponsor ID
- igorjer1
- Conditions
- Injuries and Wounds
- Keywords
- blunt trauma, pediatric patient, imaging, computer tomography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- Jan 2007
- Study completion
- Jan 2008
- First posted
- 19 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Whole body imaging has no role in asymptomatic pediatric trauma patients
Detailed description
Negative physical examination alone has been shown unreliable for excluding intra-abdominal injuries in adult patients with multitrauma. Therefore, the management of patients with a normal clinical examination after blunt trauma is a subject of controversy. Since 1970s, computer tomography (CT) has become the mainstay of evaluating hemodynamically stable trauma patients. It's generally accepted that hemodynamically stable patient with abnormal abdominal examination results require the use of CT as well as patients with depressed level of consciousness. Controversy exists with the awake, clinically evaluable patients with no obvious signs of abdominal and chest trauma. In the last years number of studies express CT role in evaluation of asymptomatic trauma patient with mechanism of injury supporting probability of internal organs injury. Those studies show that in a large number of patients the management was changed according to CT results. The authors recommended liberal use of CT in trauma patient population. All those studies have been performed in adult trauma patients. The purpose of this study is to evaluate the role of whole body imaging in pediatric patients with suspicious mechanism of injury, which are hemodynamically stable and has no obvious signs of chest and abdominal injury. The incidence of injury in these patient population as well as changes in treatment based on results of CT will be examined. Methods The prospective observational study will be performed in Assaf Harofeh Medical Center. All patients up to 15 years old with blunt mechanism of multisystem trauma will be eligible for enrollment to the study. Only patients whose parents singed the inform consent will be enrolled.Inclusion criteria will be based on the mechanism of injury: 1. no visible injury of chest and abdomen2. hemodynamically stable3. normal abdominal examination in neurologically intact patient or unevaluable abdominal examination in patients with depressed level of consciousness. 4. significant mechanism of injury as any of the following a. high speed (more than 55km/hr) motor vehicle accident b. fall of greater than 3 meters c. automobile hitting pedestrian d. assaulted with depressed level of consciousness All patients will undergo CT of the head, chest, abdomen and pelvis as a part of their evaluation. CT scan will be performed in Emergency Department short after patient's admission and clinical evaluation. An abnormal CT will be defined as exhibiting any traumatic abnormality. Patient treatment plan changes will be defined as alteration in management based directly on CT findings.Data regarding patient demographics, mechanism of injury, physical examination findings, Glasgow Coma Score on emergency department admission, Injury Severity Score, radiologic interpretation of chest and pelvic roentgenograms, injuries required operative procedures, laboratory data, CT scan findings, and changes in management plan based on CT findings will be recorded.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 month to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All asymptomatic trauma patients from 0 to 15 years old
Key exclusion criteria (1 listed)
- Any pediatric trauma patients with clinical indications for CT scan
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| whole body CT scan | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Igor Jeroukhimov, MD principal investigator
Assaf-Harofeh Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Injuries and Wounds, run by Assaf-Harofeh Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jan 2007. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2007.