NCT00581295

Brief Summary

Trauma remains the leading cause of death and disability for Americans age 1-44. Trauma can cause internal bleeding, and this bleeding is often hard to detect without sophisticate tests that take time to complete and analyze. In addition, internal bleeding, including bleeding into the lung and chest cavity, as well as other blood loss, happens in many critically ill patients. For example, for hemorrhage, it is very difficult to detect active hemorrhage and to determine optimal rates of fluid and blood resuscitation. Diffuse optical spectroscopy has the potential to accurately assess adequacy of tissue perfusion, oxygenation, tissue oxygen extraction, and cytochrome oxidation states that may be critical to optimal treatment, end- organ preservation, and survival.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
93

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2007

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2007

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 27, 2007

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

November 1, 2022

Status Verified

October 1, 2022

Enrollment Period

4.1 years

First QC Date

December 19, 2007

Last Update Submit

October 28, 2022

Conditions

Trauma

Keywords

internal bleedingchanges in tissue perfusion

Outcome Measures

Primary Outcomes (1)

  • The ability to noninvasively diagnose conditions in the intensive care unit, or in battlefield conditions.

    5 to 60 seconds

Study Arms (1)

trauma

Diffuse optical spectroscopy measurment

Device: Diffuse optical spectroscopy

Interventions

Diffuse optical spectroscopyDEVICE

Diffuse optical spectroscopy measurment

trauma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Trauma/Critically Care Patients

You may qualify if:

  • Adult age 18 years or older, male or female
  • Trauma/Critical Care patient

You may not qualify if:

  • Subject is not Trauma/Critical Care patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Beckman Laser Institute,University of California, Irvine

Irvine, California, 92612, United States

Location

Trauma/Critical Care Units, UCI Medical Center

Orange, California, 92686, United States

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • Michael E Lekawa, M.D

    Beckman Laser Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Michael E. Lekawa, MD Chief, Division of Trauma/Critical Care Surgery

Study Record Dates

First Submitted

December 19, 2007

First Posted

December 27, 2007

Study Start

March 1, 2007

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

November 1, 2022

Record last verified: 2022-10

Locations

US(2)