Development and Internal Validation of a Multimodal Prediction Score for Early Hemodynamic Deterioration in Adult Polytrauma Patients

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssiut University

About this trial

Severe traumatic injury involving multiple body regions (polytrauma) carries a high risk of rapid bleeding, tissue hypoperfusion, and circulatory collapse. In the emergency setting, standard vital signs such as blood pressure and heart rate alone may not detect impending circulatory failure until significant deterioration has already occurred.

The purpose of this prospective observational cohort study is to develop and internally validate a bedside clinical prediction model that identifies adult polytrauma patients at risk of early hemodynamic deterioration within 24 hours of arrival at the Emergency Department of Assiut University Hospital.

Eligible adult patients presenting with acute trauma across at least two major body regions within 6 hours of injury will receive standard clinical evaluation and trauma resuscitation. Alongside routine care, researchers will record baseline predictor variables during initial evaluation, including:

* Shock Index, calculated from heart rate and systolic blood pressure. * Inferior vena cava (IVC) respiratory collapsibility assessed via non-invasive bedside point-of-care ultrasound. * Initial blood gas and biochemical markers, including blood lactate concentration and base deficit. * Baseline neurological status using the Glasgow Coma Scale (GCS) and patient age.

Participants will be followed for 24 hours to monitor for hemodynamic deterioration, defined as persistent or recurrent hypotension, the need for vasopressor or inotropic medications, major blood transfusion (at least 4 units of packed red blood cells), emergency surgical or interventional procedures to control bleeding, or trauma-related circulatory collapse death. The gathered data will be analyzed according to TRIPOD guidelines to create a multimodal risk tool that can assist emergency clinicians in recognizing high-risk trauma patients early.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 years or older.

Acute traumatic injury involving at least two distinct predefined major anatomical body regions.

Presentation to the Emergency Department within 6 hours of injury.

Injuries requiring hospital-level trauma evaluation or management (operational definition of polytrauma).

Disqualifiers

Isolated trauma involving only one anatomical body region.

Age younger than 18 years.

Pregnancy.

Invasive mechanical ventilation initiated prior to baseline inferior vena cava (IVC) assessment.

Trial population

Consecutive adult polytrauma patients aged 18 years or older presenting to the Emergency Department of Assiut University Hospital within 6 hours of sustaining acute traumatic injuries involving at least two distinct predefined major anatomical body regions requiring hospital-level trauma evaluation or management.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

300 Participants
are grouped into 1 trial group
Group A: Adult Polytrauma Cohort

Trial outcomes

Primary outcomes

1

Number of Participants With Early Hemodynamic Deterioration

Number of participants experiencing early hemodynamic deterioration, defined as a single composite binary endpoint if a participant meets at least one of the following criteria: systolic blood pressure \< 90 mmHg persisting for at least 15 minutes despite initial resuscitation, initiation of vasopressor or inotropic support, transfusion of at least 4 units of packed red blood cells, emergency definitive surgical or interventional radiological hemorrhage-control procedure, or trauma-related circulatory collapse death.

Time frame
Up to 24 hours

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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