Researchers assess whether a drug given in in the prehospital setting is safe and feasible for treating severely bleeding trauma patients
Researchers at UTHealth Houston and Baylor College of Medicine, along with the Houston Fire Department (HFD), are launching a new clinical trial for a medication to treat trauma-related severe blood loss. The Houston site is participating with other trauma centers across the U.S. in this phase II trial.
Trauma, such as injury from a severe automobile accident, is the leading cause of death for people younger than 45, and one of the top causes of death overall. In trauma patients, hemorrhagic shock, which happens when severe blood loss deprives the body of oxygen, contributes to the majority of deaths within the first 24 hours.
Study purpose
The purpose of this study is to evaluate the feasibility and safety of a drug to help stop bleeding in patients that have suffered traumatic injuries. The drug, called KCentra, works by promoting clot formation. It is already approved for use in trauma patients to reverse a specific blood thinner.
Patient population
Patients who have suffered a traumatic injury and are being transported by HFD to either Memorial Hermann Texas Medical Center (emergency department) or Harris Health Ben Taub Hospital (emergency department) may qualify to participate in this study.
Study requirements
This study will require HFD medics to determine if incoming patients can participate, and medics will enroll the patient into the study if the patient is deemed eligible. Patients that are qualified for the study will be randomized. If eligible, the patient will have a 50/50 chance to either receive a one-time dose of KCentra or the placebo (a substance that has no therapeutic effect). In both cases, the patient will also receive the standard of care treatment for trauma injuries.
Enrollment timeline
Severe bleeding caused by trauma such as automobile accidents and firearm incidents are some of the leading causes of mortality in trauma patients. Given the emergency and time restrictions, paramedics don’t have enough time to both provide the timely care necessary and to obtain informed consent from the family. For this reason, patients may be enrolled into the study before giving consent.
Voluntary participation
All reasonable attempts will be made to contact a family member to discuss this study and obtain their permission to enroll the patient into the study. Once the patient or family member is contacted and can decide, they will have the opportunity to choose if the patient will remain in the study or will be withdrawn.
Patient monitoring
All patients enrolled in this study will be closely monitored throughout their participation.
Investigators
David E. Meyer, MD, MS, assistant professor of surgery with McGovern Medical School at UTHealth Houston and Chad Wilson, MD, associate professor in the Michael E. DeBakey Department of Surgery at Baylor College of Medicine, are the principal investigators for this clinical trial. Drs. Meyer, Wilson, and their teams will look at the medical data from patients enrolled into the study to see if KCentra is safe and effective for early treatment in severely injured patients.
Community Presentations
Drs. Meyer, Wilson, and members of their research teams have presented this project to various groups in Houston, Harris County, and surrounding cities and counties. During these presentations, the research team explained the project and answered any questions related to the study. Researchers are also engaging the community on social media to inform the public.
Contact Information
For more information, please contact Garrett Jost at 713-500-7298. Individuals who do not wish to participate in this proposed research study can email clinicaltrials@uth.tmc.edu to obtain an “opt-out” bracelet that must be worn for the duration of the study. More information on this trial is available on https://www.uth.edu/ctrc/participants/efic/kcentra
Media Inquiries: 713-500-3030