Denver Health has conducted the Control of Major Bleeding After Trauma (COMBAT) clinical research study, which aims to improve trauma care for all patients. The study began in April 2014 and concluded in March of 2017.

The COMBAT study, conducted in collaboration with the University of Colorado Denver, was sponsored by the Department of Defense’s Telemedicine & Advanced Technology Research Center (TATRC).

This study is different from other research studies because it involves the enrollment of patients who cannot give consent to the treatment being given due to the nature of their injuries. Regulations created by the federal government (21 Code of Federal Regulations §50.24) state the conditions under which an exception from informed consent in emergency situations is allowed. This enables important research to be done when consent is not possible due to the nature and extent of a patient’s injuries.

In order to conduct this study without initial consent, Denver Health informed and consulted with the public through community outreach in the months leading up to the study’s approval and start date. The public was informed that unless they have visible OPT OUT items, which are provided by Denver Health at no cost, subjects/patients may be enrolled in the study without their consent.

These free OPT OUT items are Denver Health specific bracelets or dog tag necklaces that specify “NO COMBAT STUDY." We realize this OPT OUT method is not perfect, as the item worn by the patient may be lost as a result of the mechanism of their traumatic injury. Due to this risk, we recommended patients wear both items (the bracelet and the dog tag necklace) to maximize the ability for the research team to understand the patient’s wishes.

Once enrolled, researchers informed the legally authorized representative (LAR) or proxy decision maker (PDM) of the research study and obtained consent for further blood samples and data collection. The LAR or PDM had the option to refuse further blood and data collection or withdraw from the research study in which case all the data for the patient will be destroyed.

The Problem:

Bleeding is the most avoidable cause of death in trauma patients. Up to one-third (1/3) of severely injured trauma patients lose the ability to form clots and as a result die from rapid and sudden blood loss. These patients need transfusion of red blood cells (RBC) and plasma which help the body to slow bleeding and restore blood volume. Plasma occurs naturally in whole blood and contains the proteins needed to form clots. When an individual experiences a traumatic injury, the plasma can become lost due to massive bleeding. This decreases the patient’s ability to form clots and ultimately stop their bleeding. Research suggests that administering plasma earlier to trauma patients who have serious and life-threatening bleeding improves their chances of survival. The plasma product being used in this study is AB-FP24. It is similar to fresh, frozen plasma but may have slightly lower levels of certain clotting proteins.

The Objective:

To determine if administering plasma to severely injured trauma patients during ambulance transport will help reduce bleeding versus plasma administered after arrival to the hospital.

The Current Standard of Care:

Guidelines by the American College of Surgeons course of Advanced Trauma Life Support recommend first giving sterile saline (salt water) in the veins after injury in order to restore blood volume. If a patient continues to have signs of major blood loss after the saline is provided, transfusion of RBC and AB-FP24 plasma is started.

Study Duration:

The COMBAT Research Study began at Denver Health in April 2014 and concluded in March of 2017.

Study Area:

Patients transported by Denver Health Paramedics to Denver Health were eligible to be a part of the study.

Study Design:

Severely injured patients in presumed hemorrhagic (acute blood loss) shock were enrolled in the study at the scene based on their vital signs (combination of blood pressure and heart rate). Once enrolled, patients were randomly chosen to receive either the control treatment, normal saline, which is the current standard of care, or the experimental treatment (AB-FP24 plasma) as the first treatment fluid. After the first treatment fluid, both groups were returned to the current standard of care. Blood samples and clinical information are collected throughout the hospital stay up to 28 days after injury.

The Reason:

The AB-FP24 plasma contains special proteins and clotting factors. This helps slow bleeding and increase blood volume, which ultimately may improve patient survival.

Learn more about Denver Health's COMBAT Research Study by watching these videos:

Watch this video to gain a better understanding of how research and clinical trials help make improvements for patients everywhere.

Note: This video, used courtesy of the National Institutes of Health and the Neurological Emergencies Treatment Trials Network, is intended to inform communities about the importance of emergency research in general. Participants in the video are not necessarily endorsing any specific clinical trial.