Overview

This trial is active, not recruiting.

Condition physical trauma
Sponsor University of Colorado, Denver
Collaborator United States Department of Defense
Start date October 2013
End date December 2017
Trial size 50 participants
Trial identifier NCT01871909, 13-0286

Summary

Lower body negative pressure (LBNP) is a laboratory model used to study hemorrhage in humans. The investigators hypothesize that the physiologic changes that occur with application of LBNP mimic those observed in bleeding and hemodynamically unstable trauma patients, and that LBNP is a truly valid model of human hemorrhage.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
Patients with report of physical trauma within 24 hours of presentation to the hospital.

Primary Outcomes

Measure
Waveform data comparison
time frame: Up to 12 months
Approximation accuracy
time frame: Up to 12 months

Eligibility Criteria

Male or female participants from 31 days up to 89 years old.

Inclusion Criteria: - age: 31 days - 89 years - patients cared for in the Emergency Department (ED), Operating Room (OR), or the Intensive Care Unit (ICU) at Denver Health Medical Center, Children's Hospital Colorado and San Antonio Military Medical Center - Patients with report of physical trauma within 24 hours of presentation at the hospital. Exclusion Criteria: - pregnant patients - incarcerated patients - patients who object at any time to participating in the study

Additional Information

Official title Validation of LBNP Model of Human Hemorrhage in Trauma Patients
Principal investigator Steve Moulton, MD
Description Specific aims: 1. Compare physiologic waveform data obtained from bleeding and hemodynamically unstable trauma patients to existing data collected from LBNP subjects. 2. Determine the accuracy of LBNP in approximating the physiologic changes that occur in bleeding and hemodynamically unstable trauma patients.
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by University of Colorado, Denver.