A Study of Testing Tranexamic Acid After Traumatic Injury in Children

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"Volunteer for research at UC Davis and contribute to discoveries that may improve health care for you, your family, and your community!"
Age: -1 to 17 years old
Gender:
Any
Healthy Volunteers: No
Keywords: Tranexamic Acid, Tranexamic Acid in children, head injury, torso injury, stomach injury, abdominal injury in children, abdominal injury, injury to child, brain injuries
Type: Drug study, Phase 2
Target:
10 Participants
Investigator:
Description
We are inviting your child to take part in this research study if s/he has suffered an injury to his/her head or torso (also called the stomach or abdominal area). The purpose of this study is to learn more about an investigational drug called tranexamic acid (TXA). Investigational means the study drug being tested has not been approved by the United States Food and Drug Administration (FDA) for use in the United States. TXA is a drug that helps with the blood clotting process in the body.

There are 4 main parts to this research study:
1. Receiving the study drug
2. Collection of several small blood samples collected over the first 24 hours of enrollment
3. Review of your child’s medical records
4. Responding to follow-up questions at different time points after enrollment through 6 months
This study requires

Your child will be assigned one of three different study drug groups through a method called randomization. This means that a computer will decide by chance which group a person is in, not the doctors running the study. In a “randomized trial” people are put in one group or another by random chance, like flipping a coin. In this study, the 3 different groups are:

• Group A (TXA 15 mg/kg bolus over 20 min then 2 mg/kg/hr over 8 hours) • Group B (TXA 30 mg/kg bolus over 20 min then 4 mg/kg/hr over 8 hours) • Group C (Placebo)

The placebo drug is a non-active product made of salt water. A placebo is a dummy treatment that looks like the study drug but is not. Placebos contain no drugs or active ingredients. Study participants are given placebos so that the effects of a drug can be compared against no drug. Use of placebos also prevents the participant and the doctor from knowing whether or not the subject is getting the drug. You will have a one in three chance of being given each study drug. Neither you nor the study doctor will know which study drug you are getting.

Once your child has been randomly assigned to a study group, some of the study drug will be administered immediately through their IV over 20 minutes. This is considered the initial dose (or bolus) and will usually happen in the Emergency Department. After the initial dose has been given, the remaining study drug will be administered through the IV slowly over the next 8 hours.

Who can participate

Inclusion criteria:

  1. Less than 18 years old AND
  2. Penetrating torso trauma, blunt torso trauma, or head trauma as defined below.
  3. Penetrating Torso Trauma: a. Penetrating trauma to the chest, abdomen, neck, pelvis or thigh with at least one of the following:
  4. age-adjusted hypotension, or
  5. age-adjusted tachycardia despite adequate resuscitation fluids, or
  6. radiographic evidence of internal hemorrhage, or
  7. clinician suspicion of ongoing internal hemorrhage
  8. Blunt Torso Trauma (at least one of the following):
  9. Clinician suspicion of hemorrhagic blunt torso injury and at least one of the following:
  10. age-adjusted hypotension, or
  11. persistent age-adjusted tachycardia despite adequate resuscitation fluids
  12. Hemothorax on chest tube placement or imaging,
  13. Clinical suspicion of hemorrhagic blunt torso injury and Intraperitoneal fluid on abdominal ultrasonography (Focused Assessment with Sonography in Trauma),
  14. Intra-abdominal injury on CT with either contrast extravasation or more than trace intraperitoneal fluid,
  15. Pelvic fracture with contrast extravasation or hematoma on abdominal/pelvic CT scan with at least one of the following:
  16. Age-adjusted tachycardia, or
  17. Age-adjusted hypotension.
  18. Head Trauma:
  19. Initial Glasgow Coma Scale (GCS) score 3 to 13 with associated intracranial hemorrhage on cranial CT scan (enroll after cranial CT scan)

Exclusion criteria:

  1. Unable to administer study drug within 3 hours of traumatic event
  2. Known pregnancy
  3. Known prisoners
  4. Known wards of the state
  5. Cardiac arrest prior to randomization
  6. GCS score of 3 with bilateral unresponsive pupils
  7. Isolated subarachnoid hemorrhage, epidural hematoma, or diffuse axonal injury
  8. Known bleeding/clotting disorders
  9. Known seizure disorders
  10. Known history of severe renal impairment
  11. Suspected non-accidental trauma (child abuse)
  12. Unknown time of injury
  13. Previous enrollment into the TIC-TOC trial
  14. Prior TXA for current injury
  15. Non-English and non-Spanish speaking
  16. Known venous or arterial thrombosis
Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
You will be paid up to $100 through gift cards for being in this research study. You will get $20 after completing the 1 week and 1 month follow-up surveys. You will get $30 after completing the 3 month follow-up surveys. You will get $50 after completing the 6-month follow-up surveys. You will be paid only for visits that you complete.
Resources
Schedule
Study duration and period
You will be in this research study for about 6 months.
Recruitment period
From Feb. 6, 2019
Location
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Research Topic
Conditions:
  • Brain Injuries
  • Wounds and Injuries
  • Hemorrhage

Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.


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