Denver Health COMBAT Research Study

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About the COMBAT Study

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Denver Health is proposing conducting a clinical research study aimed to improve trauma care for all patients. The study begins March 2013 and concludes March 2016.

The proposed research study is sponsored by the Department of Defense’s Telemedicine & Advanced Technology Research Center (TATRC) and is being conducted in collaboration with University of Colorado Denver.

This study is different from other research studies because it involves patients who cannot give consent and the treatment must be given immediately after injury. In order to conduct this study without initial consent, we must inform and consult with the public through community outreach before this study will be approved or started.  Subjects/patients may be enrolled into the study without their consent unless they have visible OPT OUT items that are FREE and provided by Denver Health.

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 so that research can be done even when consent is not possible because of the nature and extent of the patient’s injuries.

Patients may OPT OUT by wearing a free, Denver Health specific bracelet or dog tag necklace that specifies “NO COMBAT STUDY”. None of these methods are perfect since one of the methods may become lost in trauma.  It is recommended that patients use all both methods to maximize the ability for the research team to understand the patient’s wishes.  OPT OUT Registration Form.

Once enrolled, researchers will inform the legally authorized representative (LAR) or proxy decision maker (PDM) of the research study to get consent for further blood samples and data collection. The LAR or PDM can 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 cannot form clots and die from rapid and sudden blood loss. Patients need transfusion of the parts of blood, red blood cells (RBC) and plasma, to slow bleeding and restore blood volume.  Plasma has the proteins needed to clot, which can be used up in trauma. Research suggests giving plasma earlier to trauma patients who have serious and life-threatening bleeding improves survival. AB-FP24 is the plasma product being used in this study. It is similar to fresh frozen plasma (FFP) but may have slightly lower levels of certain clotting proteins.

The Objective:
To determine if giving plasma to severely injured trauma patients during ambulance transport versus after arrival to the hospital will help reduce bleeding.

The Current Standard of Care:
Guidelines by the American College of Surgeons course of Advanced Trauma Life Support (ATLS) 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 (salt water) is provided, transfusion of Red Blood Cells (RBC) and AB-FP24 plasma is started.

Study Duration:
The COMBAT Research Study (Control of Major Bleeding after Trauma) will occur at Denver Health Medical Center from March 2013 to March 2016.

Study Area:
Patients transported by Denver Health Paramedics to Denver Health Medical Center may be eligible to be a part of the study.

Study Design:
Eligible patients with major blood loss after severe trauma will be enrolled in the study at the scene based on their heart rate and blood pressure.  Once enrolled, they will be randomly chosen to receive the standard treatment, normal saline (salt water), or experimental treatment (AB-FP24 plasma) as the first treatment fluid. After the first fluid, both groups will receive the same standard of care. Blood samples and clinical information will be 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, in the end, may improve survival.


6 Comments

  1. From a research ethics perspective, this is stunning:

    (1) for three years, participants (many of whom are unconscious) will be forced to participate in an experimental trial with known medical risks;

    (2) many or most participants be unable to give informed consent;

    (3) the opt-out process is completely impractical (special “jewelry” must be worn at all times, and even then may not be seen by emergency personnel); and

    (4) nowhere in the ad (nor apparently on the study website) are the risks of Fresh Frozen Plasma (FFP) reported.

    Where are the medical ethicists at DOD or UC Denver? Leaving aside the potential value of this study, it is unacceptable to force an experimental medical procedure on patients who are unable to give informed consent, and without providing compelling evidence that it is likely to save lives to do so, nor proper notification of the potential risks.

    Jason Seidel, Psy.D.
    Director
    Colorado Center for Clinical Excellence

  2. Well put together article! I will go ahead and book mark this one for future research.
    Keep it up!

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    !

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