NCT01638481

Brief Summary

The purpose of the study is to identify the inflammatory and coagulation pathways and mechanisms that are activated immediately following burn injury, and how they affect outcomes in terms of organ failure and death. This study also addresses the limitation of current tests (PT, PTT, and platelet counts) employed to identify coagulation disturbances in severely injured patients both in a comprehensive and rapid manner.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
158

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

July 1, 2012

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

July 9, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 11, 2012

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

February 16, 2022

Status Verified

February 1, 2022

Enrollment Period

4.7 years

First QC Date

July 9, 2012

Last Update Submit

February 15, 2022

Conditions

Thermal Burns

Study Arms (5)

Group #1 - Burns affecting less than 10% BSA

Group #2 - Burns affecting 10%-30% TBSA

Group #3 - Burns affecting 31%-50% TBSA

Group #4 - Burns affecting 51%-70% TBSA

Group #5 - Burns affecting >70% TBSA

Eligibility Criteria

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

Burn injury patients will be enrolled in the study upon arrival at Trauma Center.

You may qualify if:

  • Patients, male or female, \> or = 18 years of age, who arrive at Burn/Trauma Center with anticipated admission to The Burn Center within 4 hours of injury, with a thermal burn injury due to flash, flame, contact with hot object or liquid.

You may not qualify if:

  • Patients suffering concomitant trauma that are in hemorrhagic shock. Patients with a preexisting history of coagulopathy, or currently taking anti-coagulants. Children and pregnant women. Patients with chemical or electrical injury. Patients who do not fluently speak either English or Spanish.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Study Officials

  • Jeffrey Shupp, MD

    Medstar Health Research Institute

    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

July 9, 2012

First Posted

July 11, 2012

Study Start

July 1, 2012

Primary Completion

March 1, 2017

Study Completion

June 1, 2021

Last Updated

February 16, 2022

Record last verified: 2022-02

Locations

US(1)