Which Patients Can Participate in the COMBAT Study?
Who can be in this research study?
- Patients who have lost more than 30% of their blood volume and are in shock
- Patients who are at least 18 years old
- Patients who have severe injuries
Who will not be in this research study?
- Women who are obviously pregnant
- Patients who require CPR to maintain their heartbeat
- Patients who are known and have proof of objection to blood transfusions
- Patients who are wearing a bracelet or necklace stating “NO COMBAT STUDY”
- Patients who have a family member at the scene who object to enrollment to the paramedics
What is the Design of the COMBAT Research Study?
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.
Who Qualifies for the COMBAT Study?
What is the current standard of care? How are trauma patients usually treated?
Based on the Advanced Trauma Life Support Guidelines from the American College of Surgeons, the current standard of care for trauma patients is to give sterile saline (salt water) through the veins either at the scene or in the ambulance. When the patients arrive at the hospital, they are evaluated and are given blood products including red blood cell and plasma transfusions, if they are bleeding.
How is the control and experimental group different?
Trauma patients in hemorrhagic shock are likely to receive AB-FP24 plasma regardless of the group assigned. The experimental group would receive the AB-FP24 plasma sooner (at the start of the resuscitation period) than the control group (who gets it after the initial evaluation).
Denver Health COMBAT Research Study 