Detection and Management of Non-Compressible Hemorrhage by Vena Cava Ultrasonography

This is a study of patients admitted with major traumatic injuries. Such patients may develop inadequate circulation to the organs as a result of internal blood loss. Early detection of internal blood loss can be difficult as physical examination alone may miss patients with significant blood loss. Some patients with internal bleeding will arrive with low blood pressure; these patients are usually given 2 liters of intravenous fluid to determine if their blood pressure will recover. If the blood pressure does not rise or if it drops again later, the blood loss can be assumed to be severe, and the patient will likely need transfusions, surgery and other interventions. However, this fluid treatment method can lead to delays and complications as some patients may initially respond but then continue to bleed. The inferior vena cava (IVC) is the large vein draining blood from the lower body to the heart. The inferior vena cava is known to empty when the patient has had significant blood loss. The vena cava diameter can be seen using ultrasound. This study intends to perform ultrasound to examine the vena cava diameter on patients just after arriving with major trauma. The hypothesis of the proposed study is that an ultrasound assessment protocol of inferior vena cava diameter and collapsibility can detect and aid management of non-compressible hemorrhage in major trauma victims. After the patient has been given the 2 liter intravenous fluid treatment, the inferior vena cava diameter will be measured again. A third examination 8-24 hours after admission will determine if the inferior vena cava diameter has returned to normal. We propose that measuring the inferior vena cava in this manner can predict those patients who are likely to continue bleeding and require interventions such as surgery. Early detection in these patients may avoid delays in treatment, complications and excess mortality. Because this examination is done with handheld ultrasound machines, it could be done outside hospitals and in military combat casualty care.

Study Overview

• Status: Completed
• Conditions: Wounds and Injuries; Trauma
• Intervention / Treatment: Device: Ultrasound of inferior vena cava

• Study Type: Observational
• Enrollment (Actual): 121

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92103
      • University of California San Diego Health System
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland, Shock Trauma
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • University of Utah
  • Virginia
    • Richmond, Virginia, United States, 23284
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients admitted as Major Trauma Victims via Emergency Medical Services to Level 1 Trauma Centers

Description

Inclusion Criteria:

• Major trauma patients brought to Level I Trauma Centers.
• Selected patients for the study will be those presenting with IVC collapsibility > 50% on modified-FAST at admission and/or
• IVC diameter of < 12mm on modified FAST at admission and/or
• A non-visualized IVC due to total collapse on modified FAST at admission (not due to body habitus or inadequate ultrasonography technique)

Exclusion Criteria:

• Pregnancy after 20 weeks gestation
• Those under 18 years of age
• Prisoners and others prohibited from participating in clinical trials
• Patients with severe traumatic brain injury who at admission are deemed by treating surgeons as having non-survivable brain injuries

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
IVC Collapsibility >50% or IVC < 12mm; Major Trauma Victims admitted at Level I Trauma Center with an inferior vena cava collapsibility >50% or IVC diameter less than or equal to 12mm	Device: Ultrasound of inferior vena cava
IVC Collapsibility <50% or IVC >12mm; Major Trauma Victims admitted at Level I Trauma Center with an inferior vena cava collapsibility <50% or IVC diameter >12mm	Device: Ultrasound of inferior vena cava

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
All Cause Mortality	30 Day

Secondary Outcome Measures

Outcome Measure	Time Frame
Need for hemostatic intervention	30 day
Need for blood product transfusions	30 day

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Collaborators: United States Department of Defense; Emory University; University of Utah; Virginia Commonwealth University
• Investigators: Principal Investigator: Jay J Doucet, MD, University of California, San Diego

Publications and helpful links

General Publications

• Doucet JJ, Ferrada P, Murthi S, Nirula R, Edwards S, Cantrell E, Han J, Haase D, Singleton A, Birkas Y, Casola G, Coimbra R; AAST Multi-Institutional Trials Committee. Ultrasonographic inferior vena cava diameter response to trauma resuscitation after 1 hour predicts 24-hour fluid requirement. J Trauma Acute Care Surg. 2020 Jan;88(1):70-79. doi: 10.1097/TA.0000000000002525.

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (ACTUAL): March 1, 2018
• Study Completion (ACTUAL): March 1, 2018

Study Registration Dates

• First Submitted: November 14, 2013
• First Submitted That Met QC Criteria: November 14, 2013
• First Posted (ESTIMATE): November 20, 2013

Study Record Updates

• Last Update Posted (ACTUAL): July 11, 2018
• Last Update Submitted That Met QC Criteria: July 10, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Ultrasound; Shock; Trauma; Resuscitation
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Hemorrhage
• Other Study ID Numbers: NTI-NCH-10-016; NTI W81XWH-15-1-0709 (OTHER_GRANT: National Trauma Institute)