Prehospital Kcentra for Hemorrhagic Shock
Trauma is the leading cause of death for persons between the ages of 1 and 44 years. Severe bleeding, head and/or spinal cord injuries, or a combination of these result in 80% of trauma deaths. More than half of the trauma deaths occur within the first 12 hours after the injury. The most preventable death after trauma is severe bleeding that leads to shock. Emergency treatment is given to people with serious bleeding injuries to help the body make blood clots or promote blood flow to vital organs such as the brain, heart, lungs, and kidneys. The body responds immediately to traumatic injuries by forming blood clots inside the damaged blood vessels to stop the bleeding. The blood clot may be able to stop the blood from leaking out of the damaged blood vessel.
The first priority of medical treatment is to help the body make blood clots that stop the bleeding. Paramedics use measures to help clots form such as applying direct pressure to a surface wound or applying a tourniquet (an elastic cord used to compress blood vessels when tightened by twisting) above a wound on an arm or leg. If the bleeding is inside the chest, abdomen (belly), or pelvic (lower belly) area, surgery performed in a hospital may be the only effective method to stop the bleeding. An injured person at risk for bleeding that cannot be stopped by direct pressure or a tourniquet needs to be taken to a hospital as soon as possible.
If the amount of blood lost is too large, vital organs such as the brain, heart, lungs, and kidneys will not receive the blood they need to function properly. In these cases, many people need blood products such as plasma to promote blood clotting. However, because of storage requirements, most paramedics aren’t able to carry plasma on their vehicles. A drug called KCentra, which is a four factor prothrombin complex concentrate, is often used to promote clotting in people who need to reverse the result of taking blood thinners. We believe it may also be helpful to patients who are bleeding due to their traumatic injuries.
The Prehospital KCentra trial is a multi-center trial which will enroll up to 160 patients at 4 Level Trauma Centers in the United States. Two of the centers are here in Houston and they are UTHealth/Memorial Hermann Hospital – Texas Medical Center (MHH-TMC) and Baylor University/Ben Taub General Hospital. The projected start date of the trial in the U.S. is July 2020 and the study will be enrolling participants for about 3 years and complete by 2022.
The main aim of this trial is to learn more about a drug that may be helpful in treating traumatic injuries who may require blood product to help control or stop bleeding. The study drug is called KCentra and it promotes clot formation. Dr. Meyer and Dr. Wilson and their teams will look at the resulting information to see if KCentra is safe and effective for early treatment in severely injured patients.
In this trial, Houston Fire Department medics will determine if incoming patients are possible candidates for this study, and will enroll the patient if they are considered a good candidate. Since HFD medics will be screening, enrolling, and giving the study medication prior to arrival to the hospital, there simply isn’t enough time to both provide the timely care necessary and to obtain informed consent from family. After enrollment, every effort will be made to obtain informed consent for ongoing participation from the patient or the patient’s legally authorized representative.
The Food and Drug Administration allows for the use of a process called exception from informed consent in planned emergency research in situations where patients requiring an emergent intervention following trauma are unable to provide informed consent, For more information please visit: Planned Emergency Research.
The proposed benefits of KCentra are it can help control the bleeding and patients may benefit from the controlled resuscitation prehospital. The proposed disadvantages of KCentra are headache, nausea/vomiting, arthralgia (joint pain) and hypotension (low B/P). It is possible that there are other side effects for KCentra that the doctors do not yet know about.
Any severely injured patient requiring massive transfusion of blood products is at risk for a number of complications, such as infection, bleeding, respiratory distress, and organ failure. The common side effects from KCentra include headache, nausea and vomiting, arthralgia (joint pain) and hypotension (low B/P) A committee composed of physicians, a statistician, and a former patient will meet at least every 6 months to review preliminary data from the study to assess for the potential of harm. If this committee feels that patients are being harmed by the study, the study will be halted at their recommendation.
If you wish to not participate in this trial, please request an “opt out” bracelet. As many of the patients who will be enrolled in this study will be unconscious or otherwise unable to communicate with the team of surgeons treating them, the bracelet must be worn to indicate that you do not wish to be enrolled in the stud. To request an opt-out bracelet, email clinicaltrials@uth.tmc.edu . You may also contact Dr. David Meyer, the Principal Investigator for this trial, at 713-500-7244 or Jeanette Podbielski, Research Manager, at 713-500-6407.
More information on this trial is available on clinicaltrials.gov.
