NCT01871909

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2013

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 7, 2013

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

October 8, 2019

Status Verified

October 1, 2019

Enrollment Period

5.2 years

First QC Date

May 28, 2013

Last Update Submit

October 4, 2019

Conditions

Physical Trauma

Keywords

Physical trauma

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (1)

Physical trauma

Patients with report of physical trauma within 24 hours of presentation to the hospital.

Eligibility Criteria

Age31 Days - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Trauma patients

You may qualify if:

  • 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.

You may not qualify if:

  • pregnant patients
  • incarcerated patients
  • patients who object at any time to participating in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Denver Health Medical Center

Denver, Colorado, 80204, United States

Location

San Antonio Military Medical Center

San Antonio, Texas, 78234, United States

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • Steve Moulton, MD

    Children's Hospital Colorado

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2013

First Posted

June 7, 2013

Study Start

October 1, 2013

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

October 8, 2019

Record last verified: 2019-10

Locations

US(3)