Prospective Validation of the SHOCKMATRIX Hemorrhage Predictive Model

NCT06270615 | Completed

• 1 other identifier: CRCBDD1712
• Study Type: observational
• Target: 1,584
• Locations: 1 country
• Sites: 8

Brief Summary

Management of post-traumatic severe hemorrhage remains a challenge to any trauma care system. Studying integrated and innovative tools designed to predict the risk of early severe hemorrhage (ESH) and resource needs could offer a promising option to improve clinical decisions and then shorten the time of intervention in the context of pre-hospital severe trauma. As evidence seems to be lacking to address this issue, this ambispective validation study proposes to assess on an independent cohort the predictive performance of a newly developed machine learning-based model, as well as the feasibility of its clinical deployment under real-time healthcare conditions.

Conditions

Wounds and Injuries; Traumatic Shock; Hemorrhagic Shock

Keywords

Predictive model; Ambispective validation; Machine learning; Missing values

Outcome Measures

Primary Outcomes (1)

• Fβ-score, with β = 4

  A configurable single-score metric for evaluating a binary classification model. The parameter β allows placing more emphasis on false-negative prediction error. The formula for Fβ-score is given below (TP true positives, FN false negatives, FP false positives): Fβ= ((1+β\^2 ).TP)/((1+β\^2 ).TP+ β\^2.FN+FP)

  18 months

Secondary Outcomes (1)

• Common binary classification metrics

  18 months

Study Arms (1)

Prehospital severe trauma patients

Every severe trauma patient 18 years of age or older to be admitted to a participating center excluding those already diagnosed with active hemorrhage from computed tomography findings and those with prior traumatic cardiac arrest

Other: Ambispective validation of machine learning-based predictive model

Interventions

Ambispective validation of machine learning-based predictive model OTHER

Retrospective and prospective validation of a machine learning model to predict major haemorrhage in trauma patients compared to clinician prediction

Prehospital severe trauma patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Every severe trauma adult patient to be admitted to a participating center excluding those already diagnosed with active hemorrhage from computed tomography findings, and those with prior traumatic cardiac arrest

You may qualify if:

• every severe trauma adult patient to be admitted to a participating center

You may not qualify if:

• patients already diagnosed with active hemorrhage from computed tomography findings;
• patients with prior traumatic cardiac arrest
• patient under 18 years of age
• opposition of patient or relative

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Traumabase Group: collaborator
• Capgemini Invent: collaborator
• Ecole polytechnique: collaborator
• EHESS (Ecole des hautes études en sciences sociales): collaborator
• CNRS (Centre national de la recherche scientifique): collaborator

Study Sites (8)

Beaujon Hospital AP-HP, Anesthesia-Intensive Care Department

Clichy, 92110, France

Location

Grenoble Alpes University Hospital

La Tronche, 38700, France

Location

Bicêtre Hospital AP-HP, Anesthesia-Intensive Care Department

Le Kremlin-Bicêtre, 94270, France

Location

Lille University Hospital, Anaesthesia and Intensive Care Unit

Lille, 59037, France

Location

Pitié-Salpêtrière Hospital AP-HP, Anesthesia-Intensive Care Department

Paris, 75013, France

Location

Georges-Pompidou European Hospital AP-HP, Anesthesia-Intensive Care Department

Paris, 75015, France

Location

University Hospitals Strasbourg, Anaesthesia, Intensive Care and Peri-Operative Medicine Department

Strasbourg, 67200, France

Location

University Hospital of Toulouse, Polyvalent Intensive Care

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Wounds and Injuries; Shock, Traumatic; Shock, Hemorrhagic

Condition Hierarchy (Ancestors)

Shock; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hemorrhage

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2024
• First Posted: February 21, 2024
• Study Start: July 1, 2022
• Primary Completion: June 24, 2024
• Study Completion: June 24, 2024
• Last Updated: February 18, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (8)