MedTrace Logo

A 48 Subject Study Using Non-invasive Multi-Technology Measurements for Early Detection of Ongoing Hemorrhage

NCT04814810 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 7

Last updated 2022-01-05

No results posted yet for this study

Summary

Early detection of ongoing hemorrhage (OH) before onset of hemorrhagic shock is a universally acknowledged great unmet need, and particularly important after traumatic injury. 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 would save countless lives.

This is a single site study, enrolling 48 patients undergoing liver resection in a "no significant risk" prospective clinical trial to: 1) further identify a minimal subset of noninvasive measurement technologies necessary for the desired diagnostic performance, 2) validate the performance of our Phase I algorithm, and 3) re-train the algorithm to a Phase II human iteration.

The main outcome variables are non-invasive measurements that will be used for machine learning, not real-time patient management. The data generated will be used later for discovery and validation in traditional and innovative machine learning.

Conditions

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Ohio State University

    collaborator OTHER

  • Dartmouth College

    collaborator OTHER

  • Dartmouth-Hitchcock Medical Center

    lead OTHER

Principal Investigators

  • Norman A Paradis, MD · Dartmouth-Hitchcock Medical Center

  • Mary Dillhoff, MD · Ohio State University

  • Ryan Halter, PhD · Dartmouth College

  • Vikrant Vaze, PhD · Dartmouth College

  • Jonathan Elliott, PhD · Dartmouth-Hitchcock Medical Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-01
Primary Completion
2021-04-15
Completion
2021-04-15

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 NCT04814810 on ClinicalTrials.gov