Physical TraumaNCT01871909
Validation of Lower Body Negative Pressure (LBNP) Model of Human Hemorrhage in Trauma Patients
An observational study of Physical Trauma, run by University of Colorado, Denver at 3 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 31 days to 89 years
- Conditions the study is for
- Physical Trauma
- How many people
- 50 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2013to Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 31 days to 89 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Trauma patients
Who may be able to join
- 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.
Who cannot join
- pregnant patients
- incarcerated patients
- patients who object at any time to participating in the study
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Children's Hospital Colorado
Aurora, Colorado, 80045
Denver Health Medical Center
Denver, Colorado, 80204
San Antonio Military Medical Center
San Antonio, Texas, 78234
About this study
Official title: Validation of LBNP Model of Human Hemorrhage in Trauma Patients
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.
Read the detailed description
Specific aims:
- Compare physiologic waveform data obtained from bleeding and hemodynamically unstable trauma patients to existing data collected from LBNP subjects.
- Determine the accuracy of LBNP in approximating the physiologic changes that occur in bleeding and hemodynamically unstable trauma patients.
- Conditions
- Physical Trauma
- Keywords
- Physical trauma
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Physical trauma | Patients with report of physical trauma within 24 hours of presentation to the hospital. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Waveform data comparison
Compare physiologic waveform data obtained from bleeding and hemodynamically unstable trauma patients to existing data collected from LBNP subjects.
Measured: 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.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical TraumaStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Steve Moulton, MD, Principal investigator, Children's Hospital Colorado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01871909
- Sponsor's protocol ID
- 13-0286
- Status last verified
- Oct 2019
- First submitted
- 28 May 2013
- Last updated
- 8 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of LBNP Model of Human Hemorrhage in Trauma Patients
- ClinicalTrials.gov ID
- NCT01871909
- Acronym / sponsor ID
- 13-0286
- Conditions
- Physical Trauma
- Keywords
- Physical trauma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- Oct 2013
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 7 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Compare physiologic waveform data obtained from bleeding and hemodynamically unstable trauma patients to existing data collected from LBNP subjects.
- Determine the accuracy of LBNP in approximating the physiologic changes that occur in bleeding and hemodynamically unstable trauma patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physical trauma | – | –Patients with report of physical trauma within 24 hours of presentation to the hospital. |
Who may qualify
- Ages
- 31 days to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Trauma patients
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- pregnant patients
- incarcerated patients
- patients who object at any time to participating in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2019.
Related trials for Physical Trauma
Not yet recruitingObservational study
Postural Control and Balance Performance in Patients With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Postural Assessment
RecruitingObservational study
Assessment of Blood Viscosity in ARDS (Acute Respiratory Distress Syndrome)
ARDS
Recruiting
Clinical Outcome Assessment for AT & BCI
Spinal Cord Injury, ALS (Amyotrophic Lateral Sclerosis)
Not yet recruiting
New Biomarkers for Organ Viability Assessment During Hypothermic Machine Perfusion in Liver Transplantation: the Role of Extemporaneous Histological Examination.
Liver Transplantation (LT), Early Allograft Dysfunction
Not yet recruiting
Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery
Renal Injury, Acute Kidney Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steve Moulton, MD principal investigator
Children's Hospital Colorado
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Physical Trauma, run by University of Colorado, Denver at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Waveform data comparison (time frame: Up to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2019.