COMBAT Research Study OPT OUT Registration
IMPORTANT: Before completing the OPT OUT Registration Form, Please read the following information carefully.
Denver Health Medical Center has been selected by the United States Department of Defense as a select Level 1 trauma center to perform a clinical research study evaluating the early use of fresh frozen plasma as a potentially life-saving treatment for severely injured patients who are bleeding and in shock.
Traumatic injury can happen to anyone at any time. Patients of traumatic injury often do not have the capability of declining participation in a clinical research study during emergent care. Therefore, people who do not want to participate in the COMBAT Research Study may request to OPT OUT. There are 2 methods to opt out and 1) Wear a dog tag necklace provided free by Denver Health with the words “NO COMBAT STUDY”, 2) Wear a silicone bracelet provided by free by Denver Health with the words "NO COMBAT STUDY " on it. In the trauma setting, your identification may not always be known at the time of treatment. As a result, it is recommended each person who wishes to opt out use both methods to optimize the ability of the research team to understand the person’s wishes. Denver Health paramedics and emergency department personnel have been trained to look for this dog tag necklace and bracelet and will not enroll any person with this dog tag necklace or bracelet into the study. Community members must wear this dog tag necklace and/or bracelet during the duration of the study, beginning March 2013 and continuing through March 2016.