Denver Health COMBAT Research Study

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What is the Design of the COMBAT Research Study?

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Severely injured patients in “hemorrhagic shock” will be given either saline (salt water) or thawed AB-FP24 plasma as the first treatment fluid.  A method of chance, like flipping a coin, is used to decide which treatment the patient will get.   The patient is randomized to either the standard (saline (salt water) solution) or experimental (AB-FP24 plasma) group. There is an equal chance of being in either group.

If the patient is assigned to the standard group, he/she will receive saline (salt water) as the first fluid in the ambulance. He/she will then be treated as all trauma patients are treated at the hospital. The doctors who see the patient at the hospital may decide to treat with a red blood cell (RBC) transfusion or AB-FP24 plasma. If blood products are transfused, they are donated blood products. This is the standard of care for all patients who come into the hospital after a severe injury.

If the patient is assigned to the experimental group, he/she will get 2 units AB-FP24 plasma as the first fluid in the ambulance.  After the AB-FP24 plasma, the doctors at the hospital may decide that he/she needs a RBC transfusion, saline (salt water) or more AB-FP24 plasma.  If more RBC transfusions or AB-FP24 plasma are needed, donated blood products are used.

After the first fluid treatment, both groups are treated in the same way.  Blood samples are collected at several times after injury.


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