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Trauma Study: Early Warning of Progression Toward Hemodynamic Deterioration After Trauma

NCT04912232 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2024-05-24

Study results available
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Summary

This study is Phase 3 of a three-phase DOD CDMRP funded project for the development of a multi-technology poly-anatomic noninvasive system for early detection of occult hemorrhage.

Early detection of ongoing hemorrhage (OH) before onset of shock is a universally acknowledged great unmet need, and particularly important after trauma. Delays in the detection of OH are associated with a "failure to rescue" and a dramatic deterioration in prognosis once the onset of clinically frank shock has occurred. An early alert to the presence of OH with an acceptable rate of false-positives and false-negatives would save countless lives. Additionally, such technology would save significant time, money and effort by allowing medical resources to be applied more accurately - the essence of precision medicine. An automated system would monitor currently stable patients continuously, leaving clinicians free to care for patients in need of attention.

Conditions

Interventions

DEVICE

Detection of Occult Hemorrhage in Trauma Patients

Non-invasive monitoring of trauma patients

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Dartmouth College

    collaborator OTHER

  • Baystate Medical Center

    collaborator OTHER

  • Dartmouth-Hitchcock Medical Center

    lead OTHER

Principal Investigators

  • Noman Paradis, MD · Dartmouth-Hitchcock Medical Center

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-08
Primary Completion
2022-12-08
Completion
2022-12-08
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04912232 on ClinicalTrials.gov