Status:
COMPLETED
A Multicenter, Randomized Study of Early Assessment by CT Scanning in Severely Injured Trauma Patients
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborating Sponsors:
University Medical Center Nijmegen
Erasmus Medical Center
Conditions:
Multiple Trauma/Injuries
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Computed tomography (CT) scanning has become essential in the early diagnostic phase of trauma care because of its high diagnostic accuracy. The introduction of multi-slice CT scanners and infrastruct...
Detailed Description
Injuries are the cause of 5.8 million deaths annually which accounts for almost 10% of global mortality. Among adults aged 15-59 years the proportion of injuries as cause of death is even higher, rang...
Eligibility Criteria
Inclusion
- Trauma patient with presence of one of the following criteria:
- At least one of the following parameters at hospital arrival:
- Respiratory rate ≥30/min or ≤10/min
- Pulse ≥120/min;
- Systolic blood pressure ≤100 mmHg
- Estimated external blood loss ≥500 ml
- Glasgow Coma Score ≤13
- Abnormal pupillary light reflex.
- Or clinical suspicion of one of the following diagnoses:
- Fractures from at least two long bones
- Multiple rib fractures, flail chest or open chest
- Severe abdominal injury
- Pelvic fracture
- Unstable vertebral fractures or signs of spinal cord injury.
- Or one of the following injury mechanisms:
- Fall from height (≥ 10 feet)
- Ejection from the vehicle
- Death occupant in same vehicle
- Severely injured patient in same vehicle
- Wedged or trapped chest / abdomen.
Exclusion
- Age \<18 years (if known)
- Known pregnancy
- Patients referred from other hospitals
- Clearly low-energy trauma with blunt injury mechanism
- Penetrating injury in 1 body region (except gun shot wounds) as the clearly isolated injury
- Any patient who is judged to be too unstable to undergo a CT scan and requires (cardiopulmonary) resuscitation or immediate operation because death is imminent.
Key Trial Info
Start Date :
April 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
1083 Patients enrolled
Trial Details
Trial ID
NCT01523626
Start Date
April 1 2011
End Date
December 1 2014
Last Update
February 6 2018
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Academic Medical Center (AMC)
Amsterdam, Netherlands, 1105AZ
2
University Medical Center Groningen
Groningen, Netherlands, 9700 RB
3
University Medical Centre Nijmegen
Nijmegen, Netherlands, 6525 GA
4
Erasmus Medical Center
Rotterdam, Netherlands, 3015 CE