An Observational Study of Early Coagulopathy, or Clotting Disorder, in Injured Patients

This study has been withdrawn prior to enrollment.
(PI no longer at Emory; no participants enrolled, study not conducted)
Sponsor:
Information provided by (Responsible Party):
Emory University
ClinicalTrials.gov Identifier:
NCT00744003
First received: August 27, 2008
Last updated: November 15, 2013
Last verified: November 2013
  Purpose

Trauma continues to be the major killer of young Americans, mainly due to hemorrhage or brain injury. In trauma centers, up to a quarter of these severely injured patients arrive with a coagulopathy and thereby experience an increased risk of death, despite the current standard of medical and surgical management. The PI for this grant proposal is a fellowship-trained trauma surgeon who works full-time at Grady Memorial Hospital (GMH), the only Level I Trauma Center in Atlanta. It is only one of four Level 1 trauma centers for the entire state of Georgia. This research is a direct extension of the retrospective research the PI has previously published. Her retrospective research discovered a previously undescribed form of coagulopathy, early trauma induced coagulopathy (ETIC), which cannot be explained by present paradigms. Two civilian trauma articles as well as military data from the Iraq war have substantiated the occurrence of ETIC, but no prospective literature has defined it or its kinetics. More importantly, the results from these studies represent a new paradigm shift, in which ETIC appears to be a primary dysfunction which is independently associated with death. Therefore, its early identification and correction is crucial for our mechanistic understanding, and ultimately, our choice of interventions and improved survival. GMH is a high-volume trauma center that sees patients with a variety of injury mechanisms, and, therefore, is the perfect setting to confirm ETIC. First, the project will confirm the prevalence of ETIC with an observational prospective cohort of injured patients. Data on the coagulation system and risk factors, both known and suspected, of all patients will be collected upon patient arrival as well as patient outcome with all identifying information protected. This is the first prospective research project that will allow simultaneous control of confounders associated with outcome and thereby scientifically validate the occurrence of ETIC. One unique component of our data collection is a focus on the timing of events as they relate to the development and consequences of coagulopathy, to account for the dynamic process. At the completion of data collection, a matched cohort of ETIC and non-ETIC blood samples will be tested for coagulation factors to provide insight into ETIC's pathophysiology. In the short term, our conclusions will assist us in our approach to resuscitation of the bleeding trauma patient as some trauma centers have already started to change protocols based on our present incomplete understanding of trauma-induced coagulopathy. In addition, the coagulation system data collected in this study will lead to pathophysiological answers and to more refined hypotheses for future research at a coagulation system level. Ultimately an understanding of ETIC will lead to a more effective, tailored treatment. Our main study hypothesis is that post-trauma coagulopathy is a primary dysfunction that occurs early after a traumatic event in up to 25% of all trauma patients triaged to Trauma Center care.


Condition
Trauma-induced Coagulopathy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Early Trauma Induced Coagulopathy (ETIC): A Pilot Study to Determine Its Definition and Risk Factors

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Development of coagulopathy as defined by abnormal PT/INR [ Time Frame: Admission to Trauma Center ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Plasma


Enrollment: 0
Study Start Date: July 2008
Study Completion Date: July 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Trauma patients arriving at a Level I trauma center who activated the Trauma Team criteria for a "stat pack" trauma admission

Criteria

Inclusion Criteria:

  1. > 17 years of age
  2. GMH Emergency Care Center (ECC) admission with trauma team activation - referred to by GMH nomenclature as a "STAT-pack." Trauma team activation criteria were developed from standard criteria published by the American College of Surgeons Committee on Trauma and published in Resources for Optimal Care of the Injured Patient manual 2006 edition and modified for GMH use. A trauma patient is declared a STAT-pack if they meet one of the following criteria:

    • Ejection from a motor vehicle or motorcycle
    • Extremes of age: pediatric < 6 years of age or an adult > 65 yrs of age
    • One of the following: HR > 120; RR > 30; Systolic BP < 100; GCS < 13; Basal temperature < 35 degrees C
    • Penetrating trauma to head/neck/thorax/abdomen including flank and back/antecubital fossa/groins/popliteal space
    • Suspected neurological injury i.e. spinal cord injury
    • Traumatic amputation above the wrist or ankle
    • Mangled or crush to an extremity
    • History of trauma in a patient who is combative, has deteriorating vital signs or is hemorrhaging from an open wound
    • Physician or EMS discretion
  3. Patients admitted to GMH ECC directly from the site of injury

Exclusion Criteria:

  1. < 18 years of age
  2. Any patient who is pronounced dead by health care personnel prior to any blood sampling
  3. Any patient who arrives undergoing CPR and is pronounced dead without resumption of vital signs
  4. Transfers from other health care facilities
  5. Any patient known to be taking anti-coagulant or anti-platelet medicine
  6. Any patient with a known predisposing history of a coagulation or platelet defect
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00744003

Locations
United States, Georgia
Grady Memorial Hospital
Atlanta, Georgia, United States, 30303
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Jana BA MacLeod, MD Assistant Professor Of Surgery, Emory University School of Medicine
  More Information

No publications provided

Responsible Party: Emory University
ClinicalTrials.gov Identifier: NCT00744003     History of Changes
Other Study ID Numbers: IRB00006685, ETIC Study
Study First Received: August 27, 2008
Last Updated: November 15, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemostatic Disorders
Wounds and Injuries
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders

ClinicalTrials.gov processed this record on August 01, 2014