Denver Health COMBAT Research Study

What is Plasma?

What is plasma?

Plasma is currently used as the standard treatment of trauma patients, who are actively bleeding.  In contrast, red blood cell transfusion is the part of whole blood that has the red blood cells that help carry oxygen.  FFP is taken from donors and frozen within 8 hours.  Type AB is the universal donor.   Since it must be frozen within a short time, there is a limited amount of AB-FFP and limited time to know if the plasma is AB.   To have more type AB plasma that can be given to trauma patients, we use plasma that is frozen within 24 hours called AB-FP24  plasma.  AB-FP24 plasma is almost the same as AB-FFP.    There are smaller amounts of a few specific proteins that help your body clot.  This matters for patients who need those specific proteins, but AB-FP24 plasma still works for trauma patients who need clotting proteins after severe injury.  AB-FP24 plasma used in this study is collected from pre-screened blood donors at blood banks (i.e. Bonfils Blood Center).

Regulations of this Study

Regulations established by the Federal government, (21 Code of Federal Regulations §50.24) specify the conditions under which an exception from informed consent in emergency situations is allowed so that research can be carried out even when consent is not possible because of the nature and extent of the patient’s injuries.

Why is the COMBAT Study Being Conducted?

Trauma is the leading cause of death among Americans under the age of 45.  In spite of major advances in science and medicine over the past 40 years, there have been few, if any major changes, in the early treatment of hemorrhagic shock.

Denver Health is proposing an emergency medicine research study to be conducted over 3 years in the City and County of Denver.

The title of the study is Control Of Massive Bleeding After Trauma (COMBAT) Trial: A prospective, randomized comparison of early fresh frozen plasma versus standard crystalloid intravenous fluid as initial resuscitation fluid.

Why is this research study being conducted?

The purpose of this study is to see if giving thawed plasma earlier to trauma patients will help stop bleeding. Usually we give trauma patients AB-FP24 plasma in the hospital, but we want to see if giving AB-FP24 plasma in the ambulance will help slow or stop their bleeding.

How is this study different from other research studies?

This study is different because it involves patients that cannot give consent and the treatment must be given immediately after injury. In order to do this study without initial consent, we must inform and consult with the public through community outreach before this study will be approved or started.  Eligible subjects will be enrolled into the study without their consent unless they have opt out items that can be easily seen.

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