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

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

121 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-08-31

Study Completion Date

2018-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Inferior Vena Cava (IVC) Diameters Before & After Interscalene Block

NCT03989076

IVC - Inferior Vena Cava Abnormality

WITHDRAWN

Central Venous Pressure (CVP) Assessment by Ultrasound and Physical Examination

NCT01099241

Central Venous Pressure

COMPLETED

Study of Ultrasonographic Cava Femoral Ratio in the Critically Ill Patient With Shock

NCT02891577

Hemodynamic Instability

UNKNOWN

Bedside Ultrasound Measurement of the Inferior Vena Cava Correlates to Central Venous Pressure

NCT00596921

Shock Hypovolemia Hypervolemia

UNKNOWN

Influence of the Method of Alleviation of Aorto-Caval Compression on the Trans-Hepatic Ultrasound-Assessed Inferior Vena Cava Diameter In Pregnant Patients

NCT01982513

Pregnancy Cardiac Arrest

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Trauma Wounds and Injuries

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Ultrasound of inferior vena cava

Intervention Type DEVICE

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

Ultrasound of inferior vena cava

Intervention Type DEVICE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ultrasound of inferior vena cava

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No