Traumatic Injury Clinical Trial Evaluating Tranexamic Acid in Children: A Pilot and Feasibility Study

NCT02840097 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 1023599
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 4

Brief Summary

Trauma is the leading cause of death and disability in children in the United States. The long-term goal of this project is to evaluate the benefits and harms of tranexamic acid (TXA; a drug that stops bleeding) in severely injured children. This is a 40-patient pilot study to evaluate the feasibility of two subsequent large-scale studies of TXA in injured children.

Conditions

Brain Injuries; Wounds and Injuries; Hemorrhage

Keywords

Brain injuries; Wounds and injuries; Hemorrhage; Tranexamic acid; Child

Outcome Measures

Primary Outcomes (2)

• Pediatric Quality of Life Inventory (PedsQL)

  Neurocognitive functioning and quality-of-life measures; range from 0 to 100 quality of life units with higher scores representing better outcomes. Measurements occur at 1 week, 1 month, 3 months, and 6 months to generate an area under the curve of quality of life units.

  6 months

• Pediatric Quality of Life Inventory (PedsQL)

  Neurocognitive functioning and quality-of-life measures; range from 0 to 100 with higher scores representing better outcomes

  1 week, 1 month, 3 months, and 6 months

Secondary Outcomes (7)

• Glasgow Outcome Scale-Extended (GOS-E) Peds

  1 week, 1 month, 3 months, and 6 months

• Digit Span Recall Test

  1 week, 1 month, 3 months, and 6 months

• Blood Transfusion

  First 48 hours after randomization

• Intracranial Hemorrhage Progression

  24 hours (±6 hours)

• Number of Participants With Any Non-cerebral Venous or Arterial Thrombosis

  Day 7 of hospitalization or hospital discharge (whichever comes first)

Study Arms (3)

Tranexamic acid dose A

EXPERIMENTAL

Subjects will receive a 15 mg/kg bolus of tranexamic acid over 10 minutes followed by a 2mg/kg/h over 8 hours. This represents 31mg/kg total dose of TXA.

Drug: Tranexamic Acid

Tranexamic acid dose B

EXPERIMENTAL

Subjects will receive a 30 mg/kg bolus of tranexamic acid over 10 minutes followed by a 4 mg/kg/h over 8 hours. This represents 62 mg/kg total dose of TXA.

Drug: Tranexamic Acid

Placebo

PLACEBO COMPARATOR

Subjects in the placebo group will receive a bolus dose of normal saline over 10 minutes followed by a normal saline infusion over 8 hours.

Drug: Placebo

Interventions

Tranexamic Acid DRUG

Active drug is provided to participants as described based on the TXA arm they are randomized to.

Also known as: TXA

Tranexamic acid dose A; Tranexamic acid dose B

Placebo DRUG

Normal saline is provided to participants if randomized to this treatment arm.

Also known as: 0.9% Normal Saline

Placebo

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Less than 18 years old AND
• Penetrating torso trauma, blunt torso trauma, or head trauma as defined below.
• Penetrating Torso Trauma:
• a. Penetrating trauma to the chest, abdomen, neck, pelvis or thigh with at least one of the following:
• age-adjusted hypotension, or
• age-adjusted tachycardia despite adequate resuscitation fluids, or
• radiographic evidence of internal hemorrhage, or
• clinician suspicion of ongoing internal hemorrhage
• Blunt Torso Trauma (at least one of the following):
• Clinician suspicion of hemorrhagic blunt torso injury and at least one of the following:
• age-adjusted hypotension, or
• persistent age-adjusted tachycardia despite adequate resuscitation fluids
• Hemothorax on chest tube placement or imaging,
• Clinical suspicion of hemorrhagic blunt torso injury and Intraperitoneal fluid on abdominal ultrasonography (Focused Assessment with Sonography in Trauma),
• Intra-abdominal injury on CT with either contrast extravasation or more than trace intraperitoneal fluid,

You may not qualify if:

• Unable to administer study drug within 3 hours of traumatic event
• Known pregnancy
• Known prisoners
• Known wards of the state
• Cardiac arrest prior to randomization
• GCS score of 3 with bilateral unresponsive pupils
• Isolated subarachnoid hemorrhage, epidural hematoma, or diffuse axonal injury
• Known bleeding/clotting disorders
• Known seizure disorders
• Known history of severe renal impairment
• Unknown time of injury
• Previous enrollment into the TIC-TOC trial
• Prior TXA for current injury
• Non-English and non-Spanish speaking
• Known venous or arterial thrombosis

Sponsors & Collaborators

• Daniel Nishijima, MD, MAS: lead
• Pediatric Emergency Care Applied Research Network: collaborator

Study Sites (4)

University of California, Davis

Sacramento, California, 95817, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Primary Children's Hospital

Salt Lake City, Utah, 84113, United States

Location

Related Publications (5)

• Nishijima DK, VanBuren J, Hewes HA, Myers SR, Stanley RM, Adelson PD, Barnhard SE, Bobinski M, Ghetti S, Holmes JF, Roberts I, Schalick WO 3rd, Tran NK, Tzimenatos LS, Michael Dean J, Kuppermann N; TIC-TOC Collaborators of the Pediatric Emergency Care Applied Research Network. Traumatic injury clinical trial evaluating tranexamic acid in children (TIC-TOC): study protocol for a pilot randomized controlled trial. Trials. 2018 Oct 30;19(1):593. doi: 10.1186/s13063-018-2974-z.

  PMID: 30376893 RESULT

• Nishijima DK, Gosdin M, Naz H, Tancredi DJ, Hewes HA, Myers SR, Stanley RM, Adelson PD, Burd RS, Finkelstein Y, VanBuren J, Casper TC, Kuppermann N; TIC-TOC Collaborators of the Pediatric Emergency Care Applied Research Network (PECARN). Assessment of primary outcome measures for a clinical trial of pediatric hemorrhagic injuries. Am J Emerg Med. 2021 May;43:210-216. doi: 10.1016/j.ajem.2020.03.001. Epub 2020 Mar 9.

  PMID: 32278572 RESULT

• Trappey AF 3rd, Thompson KM, Kuppermann N, Stephenson JT, Nuno MA, Hewes HA, Meyers SR, Stanley RM, Galante JM, Nishijima DK; Traumatic Injury Clinical Trial Evaluating Tranexamic Acid in Children (TIC-TOC) Collaborators of the Pediatric Emergency Care Applied Research Network (PECARN). Development of transfusion guidelines for injured children using a Modified Delphi Consensus Process. J Trauma Acute Care Surg. 2019 Oct;87(4):935-943. doi: 10.1097/TA.0000000000002432.

  PMID: 31299040 RESULT

• Powers PE, Shore KK, Perez S, Ritley D, Kuppermann N, Holmes JF, Tzimenatos LS, Shawargga H, Nishijima DK. Public Deliberation as a Novel Method for an Exception From Informed Consent Community Consultation. Acad Emerg Med. 2019 Oct;26(10):1158-1168. doi: 10.1111/acem.13827. Epub 2019 Jul 24.

  PMID: 31271691 RESULT

• Patel PA, Wyrobek JA, Butwick AJ, Pivalizza EG, Hare GMT, Mazer CD, Goobie SM. Update on Applications and Limitations of Perioperative Tranexamic Acid. Anesth Analg. 2022 Sep 1;135(3):460-473. doi: 10.1213/ANE.0000000000006039. Epub 2022 Aug 17.

  PMID: 35977357 DERIVED

Related Links

• TIC-TOC trial website

MeSH Terms

Conditions

Brain Injuries; Wounds and Injuries; Hemorrhage

Interventions

Tranexamic Acid; Saline Solution

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Daniel Nishijima, Study Co-PI
• Organization: University of California, Davis

dnishijima@ucdavis.edu

916.734.3884

Study Officials

• Daniel K Nishijima, MD, MAS

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, Emergency Medicine

Study Record Dates

• First Submitted: July 14, 2016
• First Posted: July 21, 2016
• Study Start: March 4, 2019
• Primary Completion: October 3, 2020
• Study Completion: October 3, 2020
• Last Updated: September 5, 2021
• Results First Posted: September 5, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)