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Community Survey

The COMBAT research study may affect you or someone you know who may be involved in a serious traumatic incident. We want to know what you think about it. 

There are no known risks involved in participating in this survey. Your participation in this survey is completely voluntary. You may refuse to participate or answer any questions that you do not feel comfortable answering.

THANK YOU for your help and time in completing this survey.

Welcome to the Community Survey!

Answers to this survey are anonymous. COMBAT researchers will make every effort to ensure that information you provide is maintained in a secure environment.

Any information obtained from this survey will not be shared outside of the COMBAT research study team.

E-mail addresses will not be collected.

COMBAT researchers will report and may publish information collected from this Community Survey regarding the Exception From Informed Consent research study. The anonymous information you provide will help us address any concerns raised before and during the study.

Please do not include any information that could be used to specifically identify you as an individual.

Please read the following information that tells you more about the COMBAT research study before taking the survey.

ABOUT THE STUDY

The COMBAT Research Study is a proposed research study funded by the Department of Defense to see if giving AB-FP24 plasma to trauma patients earlier in their care will help stop bleeding.  AB-FP24 plasma is usually given to patients in the hospital, but we want to see if giving AB-FP24 plasma in the ambulance will help stop the bleeding.  Patients eligible for this study are likely to receive blood products, including AB-FP24 plasma, regardless of enrollment of the study. 

Being in this research study has the following possible benefits:
• Increased survival
• Less bleeding
• Lower overall blood product transfusion
• Less risk related with multiple transfusions

The potential risks of participating in this research study are:
• Reaction to the transfusion
• Transfusion related acute lung injury: quick onset of difficulty breathing and changes on chest x-ray after a blood transfusion, not caused by other conditions. Treatment often involves a machine called a ventilator to assist breathing.
• Transmission of Hepatitis B Virus (1 in 282,000 chance), Hepatitis C virus (1 in 1,149,000 chance), Human Immunodeficiency Virus (1 in 1,467,000 chance), or malaria (1 in 4,000,000 chance)

Patients are eligible if they are:
1. Severely injured
2. Over age 18
3. Not obviously pregnant
4. Do not have medical identification refusing blood products
5. Are not wearing a bracelet or dog tag necklace stating “NO COMBAT STUDY”

Patients who do not want to be in the study may opt out by wearing a bracelet or dog tag necklace stating “NO COMBAT STUDY.” These items are provided FREE by Denver Health. (To OPT OUT and receive these items, CLICK HERE.)  None of these ways are perfect and it is recommended using both items to be sure the staff knows your wishes in the event of a trauma.

Patients who are eligible are placed without consent into one of two groups - 1) the standard group or 2) the experimental group. Patients are placed into groups at random, like flipping a coin. Patients in the standard group receive the standard of care and saline (salt water) as the first fluid into the veins. Patients in the experimental group are given AB-FP24 plasma as the first fluid into the veins.  All other treatments will be the same between the groups.

Once a legally authorized representative or proxy decision maker is found, he/she will be informed about the study and consent will be obtained for further collection of blood samples and clinical data.