The Resuscitation Outcomes Consortium (ROC) is a national research group studying better ways to treat people who have cardiac arrest or severe injury due to trauma.
Cardiac arrest is when the heart suddenly stops beating. The person collapses suddenly and is unconscious. Severe trauma can be related to car accidents or other causes.
ROC tests drugs and other new ways for treating people. We want to find out if new types of care can better help people who are very ill. ROC studies are being done in Emergency Medical Services (EMS) systems in 10 regions in the United States and Canada.
These studies are paid for by the National Institutes of Health (NIH). Some funding also comes from the Institute of Circulatory and Respiratory Health of the Canadian Institutes of Health Research, Defense Research and Development Canada, the Heart and Stroke Foundation of Canada, and the American Heart Association.
The goal of the Tranexamic Acid (TXA) in Traumatic Brain Injury (TBI) Trial is to study the effectiveness of a new type of medication in the treatment of head trauma. We will examine survival rates and overall recovery in patients who received the drug versus patients who received standard care (i.e., those not receiving the drug). We will compare 3 types of treatment in patients with traumatic brain injury. Patients will have an equal chance of being in any one of the below groups:
- Group 1: 1 gm IV TXA over 20 minutes pre-hospital, followed by 1 gm maintenance infusion initiated on hospital arrival over 8 hours
- Group 2: 2 gm IV TXA over 20 minutes pre-hospital, followed by maintenance placebo infusion over 8 hours
- Group 3: No medication (placebo - salt water solution)
This trial will help to answer the important question of whether this new drug has the ability to enhance patient survival rates and reduce the incidence of debilitating and life altering disabilities following brain injury.
Currently TXA is not administered by EMS to patients who have sustained a traumatic brain injury. The administration of the placebo therefore represents the "standard treatment" of patients, while maintaining the rigorous "double blind" nature of the trial.
The trial will take place at 12 locations across the U.S. and Canada including our local area, Multnomah and Clackamas counties.
About 1,000 patients will be enrolled in the United States and Canada.
The trial is currently underway. The first patient was enrolled in late May, 2015.
We expect the trial to last about 1 year.
Patients may enter TXA if they have a traumatic brain injury outside of the hospital in Clackamas and Multnomah counties and someone calls 911. Traumatic injuries unfortunately happen without warning. Because of this, a person cannot sign up ahead of time to be in this trial. Emergency responders must give life-supporting treatments immediately in the field to save their life. Patients are too sick to consent to this treatment.
There are serious medical situations where patients are unconscious, or have reduced cognition and so they are unable to give their permission to take part in a study. Traumatic brain injury is one of those situations. We will carry out the TXA trial under federal regulations that allow us to do this research without consent.
In 1996, the Food and Drug Administration (FDA) created specific rules that allow for emergency research without getting consent from a patient first. This is because there are some emergency medical situations where there is no time for patients or family members to give consent before treatment. These rules allow important emergency care research to take place.
According to FDA regulations, you do not have to get consent first when the research study involves people who suffer from a life-threatening disease or injury, current treatment is not effective, and often results in death anyway. Finally, the research must show the possibility of helping patients directly. ROC studies are reviewed by different groups to make sure that they meet the highest ethical standards.
Yes, the family will certainly be asked for permission and may express a desire for the medication to be withheld.
Whenever we use a new treatment, there is the potential for an element of risk. We will carefully monitor patient safety during this study, and keep track of any problems from the study treatments. Possible reactions to the study drugs may include seizures, a drug allergy, and an increase in ischemic events. Several studies have suggested that TXA is a safe and effective drug for use in the treatment of traumatic brain injury. This trial will ascertain the benefits and potential for risks associated with the general use of TXA by EMS in TBI. With TBI affecting over 1.5 million Americans every year, the use of TXA by EMS has the potential to save a great many people from serious disability and death.