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Clinical Trials/NCT01871909
NCT01871909
Completed
Not Applicable

Validation of LBNP Model of Human Hemorrhage in Trauma Patients

University of Colorado, Denver3 sites in 1 country50 target enrollmentOctober 2013
ConditionsPhysical Trauma

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Physical Trauma
Sponsor
University of Colorado, Denver
Enrollment
50
Locations
3
Primary Endpoint
Approximation accuracy
Status
Completed
Last Updated
6 years ago

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
October 2013
End Date
December 2018
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Approximation accuracy

Time Frame: Up to 12 months

Determine the accuracy of LBNP in approximating the physiologic changes that occur in bleeding and hemodynamically unstable trauma patients.

Waveform data comparison

Time Frame: Up to 12 months

Compare physiologic waveform data obtained from bleeding and hemodynamically unstable trauma patients to existing data collected from LBNP subjects.

Study Sites (3)

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