Multiple TraumaNCT07850427
Development and Internal Validation of a Multimodal Prediction Score for Early Hemodynamic Deterioration in Adult Polytrauma Patients
An observational study of Multiple Trauma and Polytrauma, run by Assiut University.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Trauma, Polytrauma, Hemodynamic Instability
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Adult, Older adult
Study 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.
Who may be able to join
- 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).
- Ability to obtain baseline predictor assessments (heart rate and systolic blood pressure for Shock Index, initial serum lactate, initial base deficit, and attempted point-of-care inferior vena cava ultrasound) as early as clinically feasible after ED arrival.
- Informed consent obtained according to institutional and ethical requirements (from the patient or legally authorized representative).
- Note: Hemodynamic stability at ED arrival is not required; patients presenting with hypotension (SBP <90 mmHg), elevated Shock Index, or clinical shock remain eligible provided baseline predictor measurements can be obtained.
Who cannot join
- 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.
- Known severe pre-existing cardiac dysfunction likely to substantially alter IVC respiratory dynamics (e.g., severe right heart failure, significant tricuspid regurgitation).
- Significant chronic hepatic dysfunction likely to substantially interfere with baseline serum lactate clearance and interpretation.
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- Traumatic obstructive shock identified before baseline assessment (e.g., tension pneumothorax, cardiac tamponade) and resolved prior to obtaining measurements.
- Transfer from an outside facility following substantial resuscitation (prior blood-product administration, vasopressor therapy, emergent surgery, or interventional radiology).
- Inability to obtain baseline predictor measurements within the initial assessment window due to immediate priority of life-saving resuscitative procedures.
- Missing baseline clinical or laboratory parameters preventing calculation of the primary prediction model.
- Note: Inability to obtain an adequate IVC acoustic window alone is recorded as an ultrasound feasibility failure and does not exclude the patient.
About this study
Official title: Development and Internal Validation of a Multimodal Prediction Score for Early Hemodynamic Deterioration in Adult Polytrauma Patients: A Prospective Cohort Study
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.
Read more
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.
- Keywords
- Shock Index, Inferior Vena Cava Collapsibility, Point-of-Care Ultrasound, Serum Lactate, Base Deficit, Clinical Prediction Model, Emergency Department, TRIPOD
- Medical subject headings
- Multiple Trauma, Shock, Traumatic, Hemorrhage, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adult Polytrauma Cohort | Consecutive adult polytrauma patients aged 18 years or older presenting to the Emergency Department within 6 hours of acute injury involving at least two distinct major anatomical regions. Participants receive standard trauma evaluation and resuscitation alongside baseline observational predictor assessments, including Shock Index (heart rate/systolic blood pressure), point-of-care ultrasound measurement of inferior vena cava (IVC) respiratory collapsibility, initial serum lactate, initial base deficit from blood gas analysis, age, and Glasgow Coma Scale (GCS). Participants are followed for 24 hours to evaluate for early hemodynamic deterioration. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple TraumaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sabrin Salman Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07850427
- Sponsor's protocol ID
- Polytrauma Deterioration Score
- Status last verified
- Sep 2026
- First submitted
- 24 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Internal Validation of a Multimodal Prediction Score for Early Hemodynamic Deterioration in Adult Polytrauma Patients: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07850427
- Acronym / sponsor ID
- Polytrauma Deterioration Score
- Keywords
- Shock Index, Inferior Vena Cava Collapsibility, Point-of-Care Ultrasound, Serum Lactate, Base Deficit, Clinical Prediction Model, Emergency Department, TRIPOD
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 30 Sep 2026 (actual)
- 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult Polytrauma Cohort | – | –Consecutive adult polytrauma patients aged 18 years or older presenting to the Emergency Department within 6 hours of acute injury involving at least two distinct major anatomical regions. Participants receive standard trauma evaluation and resuscitation alongside baseline observational predictor assessments, including Shock Index (heart rate/systolic blood pressure), point-of-care ultrasound measurement of inferior vena cava (IVC) respiratory collapsibility, initial serum lactate, initial base deficit from blood gas analysis, age, and Glasgow Coma Scale (GCS). Participants are followed for 24 hours to evaluate for early hemodynamic deterioration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (7 listed)
- 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).
- Ability to obtain baseline predictor assessments (heart rate and systolic blood pressure for Shock Index, initial serum lactate, initial base deficit, and attempted point-of-care inferior vena cava ultrasound) as early as clinically feasible after ED arrival.
Key exclusion criteria (11 listed)
- 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.
- Known severe pre-existing cardiac dysfunction likely to substantially alter IVC respiratory dynamics (e.g., severe right heart failure, significant tricuspid regurgitation).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants With Early Hemodynamic Deterioration
Time frame: Up to 24 hours
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Trauma and Polytrauma, run by Assiut University.
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 7 inclusion and 11 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: opening soon, as of the sponsor's last update on 30 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
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.
What does the primary outcome measure?
Number of Participants With Early Hemodynamic Deterioration (time frame: Up to 24 hours). It is what the study was designed to measure, not a finding.
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 30 Sep 2026.