According to Washington University School of Medicine, St. Louis, a recent study has shown that tranexamic acid has no effect on controlling blood loss in trauma patients with severe injuries when given at the doses prescribed. The drug, referred to as TXA, is routinely given in many hospitals across the U.S. to critically injured patients who suffer from severe blood loss.
In many hospitals across the U.S., the drug tranexamic acid is routinely given to critically injured patients experiencing massive blood loss. TXA is also called the drug. It has been approved to decrease blood loss for those suffering from hemophilia as well as heavy menstrual cycles. However, it is not approved to stop bleeding in patients who have suffered traumatic injuries.
A recent study by the Washington University School of Medicine in St. Louis suggests that the drug may have only minimal effects on blood clotting if it is administered within 2 hours of an injury that is severe.
These findings were recently published in Frontiers of Immunology.
These results suggest that TXA has minimal effect on the control of blood loss in trauma patients in the dosages given. We must know more about why the drug didn’t help improve blood clotting in these patients.”
Grant V. Bochicchio MD senior author, chief surgeon for critical and acute care and the Harry Edison Professor in Surgery
The trial – officially known as the TAMPITI (Tranexamic Acid Mechanisms and Pharmacokinetics Traumatic Injury) Trial – was conducted at Barnes-Jewish Hospital, where Bochicchio treats patients. The study involved 149 patients ages 18 and older with life-threatening injuries caused by car accidents and gun shots for instance they were treated in the emergency department of the hospital from March 2016 until September 2017.
TXA must be administered within two hours of the patient’s injury. Since critically ill patients might be too injured to consent, the researchers obtained approval from the Food and Drug Administration, the organization that sponsored the trial and the U.S. Department of Defense, and Washington University’s Institutional Review Board (IRB) to enroll patients with life-threatening injuries, if the patient or legally authorized family members were not able to give consent. The exception from informed consent for research in emergency situations was granted.
Participants in the study required at least one unit of blood or transfer to an operating table. They were randomly assigned to one of three intravenously administered (IV) treatments: Sterile saline (standard therapy) or a TXA dose of two grams dose or a 4 gram TXA dose. Five patients received the sterilized solution 50 received the four-gram TXA dose, and 49 were given the two-gram TXA dose after one patient was declared unfit. Patients were monitored until the time of discharge from the hospital or for 28 days, if necessary. The blood was collected at different times within 72 hours of the medication being administered.
Bochicchio who also holds an advanced master’s degree in public health, explained that blood samples were analyzed for various types of cells that affect the immune response. “There were no differences in the clinical outcomes between the three study groups with respect to mortality, cell function or the amount of blood products required after the TXA was given.”
“We were awed by the minimal impact that early intravenous TXA had upon the immune and blood-clotting system in patients suffering from severe trauma bleeding,” said Philip C. Spinella MD, first author. He was the director of the Pediatric Critical Care Translational Research Program, and is now a professor of pediatrics and pediatrics at Washington University.
Researchers also discovered that patients who received higher doses TXA had a greater risk of developing potentially dangerous blood clots. The risk of blood clots being formed was 26.5 percent for patients who received the dose of two grams of TXA and 32% for patients who received the four-gram dose of TXA as compared to 12percent for those who didn’t receive the drug. The results of another analysis (not yet published) reveal that patients who received TXA had a statistically significant increase in the risk of blood clots when compared to those who did not.
Bochicchio declared that the increased rate of potentially dangerous clots should be studied further. “As doctors, it will be our duty to determine if there is any benefit that is greater than the dangers of prescribing this drug.”
The U.S. Army Institute of Surgical Research located in San Antonio, Tex. as well as Duke University School of Medicine in Durham, N.C., also participated in the research.
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