Validation of Lower Body Negative Pressure (LBNP) Model of Human Hemorrhage in Trauma Patients

Physical Trauma Clinical Trial

Official title:

Validation of LBNP Model of Human Hemorrhage in Trauma Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01871909
• Other study ID #: 13-0286
• Status: Completed
• Start date: October 2013
• Est. completion date: December 2018

Study information

• Verified date: October 2019
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 31 Days to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Physical Trauma
• Wounds and Injuries

Locations

Country	Name	City	State
United States	Children's Hospital Colorado	Aurora	Colorado
United States	Denver Health Medical Center	Denver	Colorado
United States	San Antonio Military Medical Center	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Waveform data comparison	Compare physiologic waveform data obtained from bleeding and hemodynamically unstable trauma patients to existing data collected from LBNP subjects.	Up to 12 months
Primary	Approximation accuracy	Determine the accuracy of LBNP in approximating the physiologic changes that occur in bleeding and hemodynamically unstable trauma patients.	Up to 12 months