NCT02840097 (TIC-TOC) is a Phase 2 clinical trial of Tranexamic Acid in Brain Injuries, sponsored by Daniel Nishijima, MD, MAS.

Who is sponsoring NCT02840097?

NCT02840097 is sponsored by Daniel Nishijima, MD, MAS.

What drugs are being tested in NCT02840097?

Interventions in NCT02840097: Tranexamic Acid, Placebo.

What condition does NCT02840097 study?

NCT02840097 studies Brain Injuries, Wounds and Injuries, Hemorrhage.

Is NCT02840097 still recruiting?

NCT02840097 is currently completed. Last updated 5 September 2021.

Are results published for NCT02840097?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-09-05 · How we verify

NCT02840097: TIC-TOC

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 2 Results posted Last updated 5 September 2021

What this trial tests

Phase 2 trial testing Tranexamic Acid in Brain Injuries in 31 participants. Completed in 3 October 2020.

Timeline

4 March 2019

Primary endpoint
3 October 2020

3 October 2020

Quick facts

Lead sponsor	Daniel Nishijima, MD, MAS
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	31
Start date	4 March 2019
Primary completion	3 October 2020
Estimated completion	3 October 2020
Sites	4 locations across United States

Drugs / interventions tested

Tranexamic Acid (Tranexamic Acid) — full drug profile →
Placebo

Conditions studied

Brain Injuries — all drugs for Brain Injuries →
Wounds and Injuries — all drugs for Wounds and Injuries →
Hemorrhage — all drugs for Hemorrhage →

Sponsor

Daniel Nishijima, MD, MAS

Who can join

Under 17, any sex, with Brain Injuries or Wounds and Injuries. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Pediatric Quality of Life Inventory (PedsQL) Primary · 6 months

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.

Group	Value	95% CI
Tranexamic Acid Dose A	64.9	± 19.0
Tranexamic Acid Dose B	60.2	± 12.3
Placebo	67.2	± 20.0

Pediatric Quality of Life Inventory (PedsQL) Primary · 1 week, 1 month, 3 months, and 6 months

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

1 week

Group	Value	95% CI
Tranexamic Acid Dose A	43.7	± 24.0
Tranexamic Acid Dose B	52.4	± 20.1
Placebo	57.9	± 28.6

1 month

Group	Value	95% CI
Tranexamic Acid Dose A	57.0	± 19.8
Tranexamic Acid Dose B	61.5	± 16.9
Placebo	60.5	± 27.9

3 months

Group	Value	95% CI
Tranexamic Acid Dose A	77.3	± 23.6
Tranexamic Acid Dose B	77.5	± 18.5
Placebo	68.9	± 22.5

6 months

Group	Value	95% CI
Tranexamic Acid Dose A	81.6	± 23.0
Tranexamic Acid Dose B	84.3	± 9.9
Placebo	68.9	± 25.9

Glasgow Outcome Scale-Extended (GOS-E) Peds Secondary · 1 week, 1 month, 3 months, and 6 months

Global functioning; range is 1 to 8 with higher scores representing better outcomes; 1=death, 2=vegetative state, 3=lower severe disability, 4=upper severe disability, 5=lower moderate disability, 6=upper moderate disability, 7=lower good recovery, 8=upper good recovery

1 week

Group	Value	95% CI
Tranexamic Acid Dose A	4.6	± 2.3
Tranexamic Acid Dose B	5.2	± 1.8
Placebo	5.3	± 2.2

1 month

Group	Value	95% CI
Tranexamic Acid Dose A	4.9	± 2.0
Tranexamic Acid Dose B	5.1	± 1.4
Placebo	4.5	± 2.2

3 months

Group	Value	95% CI
Tranexamic Acid Dose A	3.8	± 2.3
Tranexamic Acid Dose B	4.6	± 1.3
Placebo	4.2	± 2.4

6 months

Group	Value	95% CI
Tranexamic Acid Dose A	3.7	± 2.6
Tranexamic Acid Dose B	2.9	± 2.3
Placebo	4.3	± 2.3

Digit Span Recall Test Secondary · 1 week, 1 month, 3 months, and 6 months

Test of working memory; higher scores represent a better outcome, range from 0 to infinity

Total forward digit span, 1 week

Group	Value	95% CI
Tranexamic Acid Dose A	8.4	± 1.7
Tranexamic Acid Dose B	8.4	± 4.3
Placebo	8.8	± 2.8

Total backward digit span, 1 week

Group	Value	95% CI
Tranexamic Acid Dose A	6.0	± 1.6
Tranexamic Acid Dose B	6.0	± 3.3
Placebo	7.3	± 1.0

Total forward digit span, 1 month

Group	Value	95% CI
Tranexamic Acid Dose A	7.2	± 1.9
Tranexamic Acid Dose B	7.9	± 3.7
Placebo	7.5	± 2.6

Total backward digit span, 1 month

Group	Value	95% CI
Tranexamic Acid Dose A	6.2	± 1.8
Tranexamic Acid Dose B	6.2	± 1.3
Placebo	5.3	± 2.6

Total forward digit span, 3 months

Group	Value	95% CI
Tranexamic Acid Dose A	9.1	± 3.6
Tranexamic Acid Dose B	10.4	± 1.5
Placebo	8.6	± 2.5

Total backward digit span, 3 months

Group	Value	95% CI
Tranexamic Acid Dose A	8.7	± 3.6
Tranexamic Acid Dose B	7.8	± 0.8
Placebo	6.5	± 1.1

Total forward digit span, 6 months

Group	Value	95% CI
Tranexamic Acid Dose A	11.7	± 3.9
Tranexamic Acid Dose B	10.0	± 2.4
Placebo	8.4	± 2.3

Total backward digit span, 6 months

Group	Value	95% CI
Tranexamic Acid Dose A	10.4	± 4.1
Tranexamic Acid Dose B	6.0	± 2.4
Placebo	5.8	± 2.9

Blood Transfusion Secondary · First 48 hours after randomization

Total volume of packed red blood cells, platelets, fresh frozen plasma, and cryoprecipitate

Group	Value	95% CI
Tranexamic Acid Dose A	367.4	± 821.5
Tranexamic Acid Dose B	150.4	± 214.1
Placebo	303.6	± 571.9

Intracranial Hemorrhage Progression Secondary · 24 hours (±6 hours)

Intracranial hemorrhage progression on cranial computed tomography (CT) imaging; hemorrhage will be measured using the ABC/2 volume estimation and relative to the total brain volume (calculated by the XYZ/2 volume estimation); more intracranial hemorrhage progression represents a worse outcome. Change is calculated as the difference between the baseline and repeat cranial CT imaging. The repeat CT is conducted 24 hours (±6 hours) after the baseline CT.

Group	Value	95% CI
Tranexamic Acid Dose A	0.003	± 0.004
Tranexamic Acid Dose B	0.001	± 0.001
Placebo	0.003	± 0.013

Number of Participants With Any Non-cerebral Venous or Arterial Thrombosis Secondary · Day 7 of hospitalization or hospital discharge (whichever comes first)

Any non-cerebral venous or arterial thrombosis on standard diagnostic imaging post-randomization

Group	Value	95% CI
Tranexamic Acid Dose A	0
Tranexamic Acid Dose B	0
Placebo	0

Number of Participants With Seizures Secondary · 24 hours after receiving drug

Clinical or electroencephalogram-documented

Group	Value	95% CI
Tranexamic Acid Dose A	0
Tranexamic Acid Dose B	0
Placebo	1

Adverse events — posted to ClinicalTrials.gov

Time frame: 6 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Tranexamic Acid Dose A

Serious: 0/9 (0%)

Deaths: 0/9

Tranexamic Acid Dose B

Serious: 0/10 (0%)

Deaths: 0/10

Placebo

Serious: 1/12 (8%)

Deaths: 0/12

Serious adverse events (1 terms)

Reaction	System	Tranexamic Acid Dose A	Tranexamic Acid Dose B	Placebo
Seizure	Nervous system disorders	—	—	—

Other adverse events (1 terms — click to expand)

Reaction	System	Tranexamic Acid Dose A	Tranexamic Acid Dose B	Placebo
Adverse Event	General disorders	—	—	—

Most-reported serious reactions: Seizure.

Data from ClinicalTrials.gov NCT02840097 adverse events section.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Development of transfusion guidelines for injured children using a Modified Delphi Consensus Process.
Trappey AF, Thompson KM, Kuppermann N, Stephenson JT, et al · · 2019 · cited 15× · PMID 31299040 · DOI 10.1097/ta.0000000000002432
Traumatic injury clinical trial evaluating tranexamic acid in children (TIC-TOC): study protocol for a pilot randomized controlled trial.
Nishijima DK, VanBuren J, Hewes HA, Myers SR, et al · · 2018 · cited 14× · PMID 30376893 · DOI 10.1186/s13063-018-2974-z
Traumatic injury clinical trial evaluating tranexamic acid in children (TIC-TOC): A pilot randomized trial.
Nishijima DK, VanBuren JM, Linakis SW, Hewes HA, et al · · 2022 · cited 13× · PMID 35266589 · DOI 10.1111/acem.14481

Verify or expand the search:

Other trials of Tranexamic Acid

Trials testing the same drug.

NCT07501884 — REDUCER Trial (TXA in Urethroplasty) · Phase 4 · not yet recruiting
NCT07460518 — Tranexamic Acid for Bleeding Reduction During TURP Surgery · Phase 4 · not yet recruiting
NCT07390799 — Prophylactic Tranexamic Acid in Low-Risk Repeat Cesarean Delivery: A Randomized Controlled Trial · NA · not yet recruiting
NCT07078942 — Prophylactic Intravenous Tranexamic Acid on Perioperative Blood Loss in Pregnant Women Undergoing Cesarean Section · Phase 4 · not yet recruiting
NCT07263841 — Comparison of Effectiveness of Tranexamic Acid Mesotherapy Versus Glutathione Mesotherapy in Post Burn Facial Hyperpigme · Phase 2 · active not recruiting

Other recruiting trials for Brain Injuries

Currently open trials in the same condition.

NCT06607523 — The Gut-Brain Axis During Neurorehabilitation; Prebiotic Treatment to Alter the Gut Microbiome and Neurologic Symptoms · NA · recruiting
NCT06873477 — Evaluation of Patients Affected by Traumatic and Hypoxic-ischemic Brain Injury · recruiting
NCT06511804 — Correlation Between Noninvasive Blood Vessel Functionality Parameters and Cerebral Hemodynamics in Neurocritical Care Pa · recruiting
NCT06863025 — Effects of Neurofeedback Training on Attentional Deficits in Patients With Acquired Brain Injury · NA · active not recruiting
NCT06571032 — Electroencephalography in the Management of Neuroelectric Stimulation in Patients With Severe Traumatic Brain Injuries · recruiting

Other Daniel Nishijima, MD, MAS trials

Trials by the same sponsor.

NCT04387305 — Traumatic Injury Clinical Trial Evaluating Tranexamic Acid in Children: An Efficacy Study · Phase 3 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02840097 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Daniel Nishijima, MD, MAS
Last refreshed: 5 September 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02840097.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing