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A multicenter, randomized study of early assessment by CT scanning in severely injured trauma patients.

A randomized comparison between immediate 'total body' CT during the primary survey of severely injured trauma patients and conventional ATLS based radiological imaging supplemented with selective CT scanning.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON27189
Enrollment
1078
Registered
2010-11-17
Start date
2011-04-20
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Computed Tomography (CT) scanning Total body CT Trauma Trauma resuscitation room Primary survey CT Totale lichaam CT Trauma Traumakamer Trauma-opvang

Interventions

Immediate ‘total body’ CT scan without preceding conventional radiography (i.e. X-rays and FAST ultrasound).

Sponsors

Academic Medical Center.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Trauma patient with presence of one of the following criteria: At least one of the following parameters at hospital arrival: 1. Respiratory rate ≥30/min or ≤10/min; 2. Pulse ≥120/min; 3. Systolic blood pressure ≤100 mmHg; 4. Estimated external blood loss ≥500 ml; 5. Glasgow Coma Score ≤13; 6. Abnormal pupillary light reflex on site. Or clinical suspicion of one of the following diagnoses: 1. Patients with signs of fractures from at least two long bones; 2. Patients with clinical signs of flail chest, open chest or multiple rib fractures; 3. Patients with clinical signs of severe abdominal injury; 4. Patients with a clinically evident pelvic fracture; 5. Patients with signs of unstable vertebral fractures or signs of spinal cord compression. Or one of the following injury mechanisms: 1. Fall from height (>3 meters / > 10 feet); 2. Ejection from the vehicle; 3. Death occupant in same vehicle; 4. Severely injured patient in same vehicle; 5. Wedged or trapped chest / abdomen.

Exclusion criteria

Exclusion criteria: 1. Age <18 years (if known); 2. Known pregnancy; 3. Patients referred from other hospitals; 4. Clearly low energy trauma with blunt injury mechanism; 5. Any patient with a penetrating head / neck injury (except gun shot wounds) as the clearly isolated injury; 6. 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. Inclusion criteria and exclusion criteria are decided upon by trauma team leader in mutual agreement with the other relevant trauma team members.

Design outcomes

Primary

MeasureTime frame
In-hospital mortality.

Secondary

MeasureTime frame
1. Mortality and morbidity during the first year post trauma; 2. General health at 6 and 12 months post trauma; 3. Several clinically relevant time intervals; 4. Differences in radiation exposure; 5. Differences in cost-effectiveness.

Contacts

Public ContactKaij Treskes

Mailbox 22660 AMC, Trauma Unit, Surgery Department / G4-134

k.treskes@amc.nl+31 (0)20 5666676

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)