Chronology of Occult and Gross Coagulopathy in Burn Patients

NCT ID: NCT01638481

Last Updated: 2022-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

158 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-07-31

Study Completion Date

2021-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Thermal Burns

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Group #1 - Burns affecting less than 10% BSA

No interventions assigned to this group

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

No interventions assigned to this group

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

No interventions assigned to this group

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

No interventions assigned to this group

Group #5 - Burns affecting >70% TBSA

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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United States Department of Defense

FED

Sponsor Role collaborator

Medstar Health Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeffrey Shupp, MD

Role: PRINCIPAL_INVESTIGATOR

Medstar Health Research Institute

Locations

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MedStar Washington Hospital Center

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

Site Status

Countries

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United States

Other Identifiers

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58802-LS

Identifier Type: -

Identifier Source: org_study_id

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