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Posted: 11/30/2015
ROTATeIT trial seeks best option for trauma patients
Anyone who watches TV dramas like “Code Black,” “Grey’s Anatomy” or “House” knows it can be crucial to deliver IV blood transfusions quickly to patients who have suffered significant trauma.
Now, a new research trial at Parkland Health & Hospital System is trying to find the best way to deliver transfusions and potentially save many more lives. And technology is at the heart of the study.
According to Michael Cripps, MD, a trauma surgeon at Parkland and Assistant Professor in the Department of Surgery at The University of Texas Southwestern Medical Center in the Division of Burn/Trauma/Critical Care, “New medical techniques have the potential to significantly improve the outcomes of injured people and reduce fatalities. The purpose of the new clinical ROTATeIT trial we’re conducting at Parkland is to determine if using technology can improve transfusion rates in bleeding patients. The results could benefit people all over the world, as well as Parkland patients.”
Trauma is the leading cause of death in young adults and acute blood loss contributes to a large number of deaths in the early post-trauma period, according to the National Institutes of Health. Trauma is also one of the leading causes of death for individuals over 65. According to the Centers for Disease Control and Prevention, more than 192,000 injury-related deaths occur each year in the U.S.
Many of these individuals require transfusions. In fact, blood transfusions are extremely common, with almost 5 million Americans receiving transfusions annually.
“People who have experienced massive blood loss due to severe injury need blood transfusions as part of the treatment to save their life,” Dr. Cripps said. “However, blood transfusions can also be harmful, especially if the patient receives too much blood. The ROTATeIT trial is designed to evaluate the use of technology to guide transfusions to get the best possible outcome for the patient.”
ROTATeIT is an acronym for “Rotational Thromboelastometry Applied Transfusion in Trauma.” As part of the study, a ROTEM (rotational thromboelastometry) analyzer is used that provides patient-specific data during treatment, allowing the physician to monitor the patient’s response in real-time during transfusion and to transfuse only those blood factors that are needed and avoid blinded transfusions.
People with severe injuries brought to the Rees-Jones Trauma Center at Parkland who qualify for the study will receive one of two currently used treatments assigned by chance.
“By comparing results of treatment options, the study will help providers determine which treatments are most likely to benefit trauma patients and save more lives,” said Dr. Cripps.
Both treatment options evaluated in the trial are currently used around the world and at Parkland. According to Dr. Cripps, there is currently no agreement in the medical community that one approach is better than the other.
Although patients who may be part of a research study usually are told about the risks and benefits of the study and their legal rights before they receive any study intervention, in this trial patients brought to Parkland in emergencies will be automatically assigned to the trial without obtaining the usual informed consent of the patient.
“In an emergency, there’s not enough time to get consent from the patient or their family,” Dr. Cripps explained. “Thus, emergency research must be done with an exception to informed consent. In addition, someone who is unconscious due to severe injury would also be enrolled in the ROTATeIT trial if they meet the criteria for the study.”
The patient or their representative will be made aware in person, by phone or via letter that they were enrolled in the ROTATeIT trial and the study will be described to them by a research staff member at that time.
Individuals can opt out of the study if they desire by contacting the ROTATeIT trial coordinators. Those opting out will receive a purple “NON-ROTATeIT” labeled wristband at no cost. If injured while wearing the wristband and brought to Parkland, the person will not be enrolled in the trial. Community members who do not wish to participate in this research study can contact Agnes Burris at Agnes.Burris@UTSouthwestern.edu or phone 214.648.3521 to receive their free opt out wristband.
The estimated duration of the trial, which is funded by the Eastern Association for The Surgery of Trauma (EAST), is two years.
To learn more about ROTATeIT, please visit www.rotatetrial.com.