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

NCT01989273 | Completed

• 2 other identifiers: NTI-NCH-10-016NTI W81XWH-15-1-0709
• Study Type: observational
• Target: 121
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Trauma; Wounds and Injuries

Keywords

Trauma; Ultrasound; Shock; Resuscitation

Outcome Measures

Primary Outcomes (1)

• All Cause Mortality

  30 Day

Secondary Outcomes (2)

• Need for hemostatic intervention

  30 day

• Need for blood product transfusions

  30 day

Study Arms (2)

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

Interventions

Ultrasound of inferior vena cava DEVICE

IVC Collapsibility <50% or IVC >12mm; IVC Collapsibility >50% or IVC < 12mm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead
• United States Department of Defense: collaborator
• Emory University: collaborator
• University of Utah: collaborator
• Virginia Commonwealth University: collaborator

Study Sites (5)

University of California San Diego Health System

San Diego, California, 92103, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

University of Maryland, Shock Trauma

Baltimore, Maryland, 21201, United States

Location

University of Utah

Salt Lake City, Utah, 84112, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23284, United States

Location

Related Publications (1)

• 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.

  PMID: 31688824 DERIVED

MeSH Terms

Conditions

Wounds and Injuries; Shock

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jay J Doucet, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: November 14, 2013
• First Posted: November 20, 2013
• Study Start: August 1, 2012
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: July 11, 2018

Record last verified: 2018-07

Locations

US (5)