Viewing Study NCT06270615



Ignite Creation Date: 2024-05-06 @ 8:09 PM
Last Modification Date: 2024-10-26 @ 3:21 PM
Study NCT ID: NCT06270615
Status: RECRUITING
Last Update Posted: 2024-02-21
First Post: 2024-02-14

Brief Title: Prospective Validation of the SHOCKMATRIX Hemorrhage Predictive Model
Sponsor: Assistance Publique - Hôpitaux de Paris
Organization: Assistance Publique - Hôpitaux de Paris

Study Overview

Official Title: External Validation of a Real-time Machine Learning-based Predictive Model for Early Severe Hemorrhage and Hemorrhage Resource Needs in Trauma Patients
Status: RECRUITING
Status Verified Date: 2024-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: SHOCKMATRIX
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
Detailed Description: Background Hemorrhagic shock remains the leading cause of early preventable death in severely injured patients When a severe hemorrhage occurs shortly after serious trauma thus defining an early severe hemorrhage ESH its management becomes highly challenging In this context improving clinical decisions and shortening the time of intervention known as a critical endpoint may require designing innovative tools for early detection as well as studying their integration within the routine healthcare process

Objective Part of the TRAUMATRIX project led by the Traumabase Group in partnership with Capgemini Invent and several research centers Ecole polytechnique CNRS EHESS this study aims to externally validate a recently developed machine learning-based predictive model for ESH in trauma patients This model previously trained on a high-quality trauma database named Traumabase offers a specific ability to handle missing values

Materials and Methods At least 1500 adult trauma patients from 8 French trauma centers will be included for a six-24 month period with a retrospective and prospective sample ESH will stand as our primary outcome defined as any of the following events occurring within the first hours of trauma management any packed red blood cell RBC transfusion in the resuscitation room or transfusion exceeding 4 RBCs within the first 6 hours or emergency hemostatic intervention surgery or interventional radiology or death in an unambiguous setting of uncontrolled objectified hemorrhage Data of interest will be collected in two phases 1 from the prehospital phase of the trauma management where the variables needed to calculate the algorithmic prediction of ESH 10 inputs as well as the clinical prediction from the attending trauma leader receiving in the resuscitation room a pre-alert call from the dispatch center will be recorded in real-time using a dedicated user-friendly smartphone interface developed by the Capgemini Invent teams 2 from a delayed phase where a classic inclusion in the Traumabase will be performed to retrieve the component variables of the ESH composite endpoint and a feedback survey will be sent to the trauma teams involved in the study to collect additional informative data The prospective data collected we will compare to a retrospective cohort predictive performance of two systems namely the clinical trauma expert versus our machine learning-based predictive model

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None