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NCT04814810

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

Terminated Last updated 5 January 2022
What this trial tests

trial in Occult Bleeding in 7 participants. Terminated before completion.

Timeline
1 February 2021
Primary endpoint
15 April 2021
15 April 2021

Quick facts

Lead sponsorDartmouth-Hitchcock Medical Center
StatusTerminated
Study typeOBSERVATIONAL
Enrollment7
Start date1 February 2021
Primary completion15 April 2021
Estimated completion15 April 2021
Sites1 location across United States

Conditions studied

Sponsor

Dartmouth-Hitchcock Medical Center

Who can join

18 and older, any sex, with Occult Bleeding or Hemorrhage. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other Dartmouth-Hitchcock Medical Center trials

Trials by the same sponsor.

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Data sources for this page

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