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Traumatic Brain InjuryPhase 2TXANCT01990768

Prehospital Tranexamic Acid Use for Traumatic Brain Injury

A Phase 2 study testing 1 gram Tranexamic Acid (TXA), 2 grams TXA and 0.9% Sodium Chloride injectable in people with Traumatic Brain Injury, run by University of Washington at 12 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Primary aim: To determine the efficacy of two dosing regimens of TXA initiated in the prehospital setting in patients with moderate to severe TBI (GCS score ≤12). Primary hypothesis: The null hypothesis is that random assignment to prehospital administration of TXA in patients with moderate to severe TBI will not… Read more about this study

Who is it for?
Ages 15 years and older
Conditions the study is for
Traumatic Brain Injury
What is being tested?
1 gram Tranexamic Acid (TXA), 2 grams TXA and 0.9% Sodium Chloride injectable
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
967 participants
Where
12 sitesin 2 countries
Study dates
May 2015to 7 Nov 2017
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Blunt or penetrating traumatic mechanism consistent with traumatic brain injury
  • Prehospital Glasgow Coma Score (GCS) score ≤ 12 at any time prior to randomization and administration of sedative and/or paralytic agents
  • Prehospital systolic blood pressure (SBP) ≥ 90 mmHg prior to randomization
  • Prehospital intravenous (IV) or intraosseous (IO) access
  • Estimated Age ≥ 15 (or estimated weight > 50 kg if age is unknown)
  • Emergency Medicine System (EMS) transport to a participating trauma center

Who cannot join

  • Prehospital GCS=3 with no reactive pupil
  • Estimated time from injury to hospital arrival > 2 hours
  • Unknown time of injury - no known reference times to support estimation
  • Clinical suspicion by EMS of seizure activity or known history of seizures, acute myocardial infarction (MI) or stroke
  • Cardio-pulmonary resuscitation (CPR) by EMS prior to randomization
  • Burns > 20% total body surface area (TBSA)
Show all 10Show fewer
  • Suspected or known prisoners
  • Suspected or known pregnancy
  • Prehospital TXA given prior to randomization
  • Subjects who have activated the "opt-out" process when required by the local regulatory board

Trial locations and contacts

12 sites in 2 countries.

12 sites in 2 countries

United States10 sites

  • Alabama Resuscitation Center

    Birmingham, Alabama, 35249

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45267

  • Dallas Center for Resuscitation Research

    Dallas, Texas, 75390

  • Memorial Hermann Hospital - Texas Medical Center

    Houston, Texas, 77030

  • Milwaukee Resuscitation Research Center

    Milwaukee, Wisconsin, 53226

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

  • Oregon Health & Sciences University

    Portland, Oregon, 97239-3098

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905

  • St Paul Regions Hospital

    Saint Paul, Minnesota, 55101

  • Harborview Medical Center

    Seattle, Washington, 98104

Other trials in United States

Canada2 sites

  • Toronto RescuNet

    Toronto, Ontario, M5B 1W8

  • British Columbia Regional Coordinating Center

    Vancouver, British Columbia, V5Z 1 M9

Other trials in Canada

About this study

Primary aim: To determine the efficacy of two dosing regimens of TXA initiated in the prehospital setting in patients with moderate to severe TBI (GCS score ≤12).

Primary hypothesis: The null hypothesis is that random assignment to prehospital administration of TXA in patients with moderate to severe TBI will not change the proportion of patients with a favorable long-term neurologic outcome compared to random assignment to placebo, based on the GOS-E at 6 months.

Read more

Secondary aims: To determine differences between TXA and placebo in the following outcomes for patients with moderate to severe TBI treated in the prehospital setting with 2 dosing regimens of TXA:

  • Clinical outcomes: ICH progression, Marshall and Rotterdam CT classification scores, DRS at discharge and 6 months, GOS-E at discharge, 28-day survival, frequency of neurosurgical interventions, and ventilator-free, ICU-free, and hospital-free days.
  • Safety outcomes: Development of seizures, cerebral ischemic events, myocardial infarction, deep venous thrombosis, and pulmonary thromboembolism.
  • Mechanistic outcomes: Alterations in fibrinolysis based on fibrinolytic pathway mediators and degree of clot lysis based on TEG.

Inclusion: Blunt and penetrating traumatic mechanism consistent with TBI with prehospital GCS ≤ 12 prior to administration of sedative and/or paralytic agents, prehospital SBP ≥ 90 mmHg, prehospital intravenous (IV) access, age ≥ 15yrs (or weight ≥ 50kg if age is unknown), EMS transport destination based on standard local practices determined to be a participating trauma center.

Exclusion: Prehospital GCS=3 with no reactive pupil, estimated time from injury to start of study drug bolus dose >2 hours, unknown time of injury, clinical suspicion by EMS of seizure activity, acute MI or stroke or known history, to the extent possible, of seizures, thromboembolic disorders or renal dialysis, CPR by EMS prior to randomization, burns > 20% TBSA, suspected or known prisoners, suspected or known pregnancy, prehospital TXA or other pro-coagulant drug given prior to randomization, subjects who have activated the "opt-out" process when required by the local regulatory board.

A multi-center double-blind randomized controlled trial with 3 treatment arms:

  • Bolus/maintenance: 1 gram IV TXA bolus in the prehospital setting followed by a 1 gram IV maintenance infusion initiated on hospital arrival and infused over 8 hours.
  • Bolus only: 2 grams IV TXA bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.
  • Placebo: Placebo IV bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.
Read the detailed description
  1. Overview This multi-center, Phase II trial is designed to determine if Tranexamic Acid (TXA) initiated in the prehospital setting improves long-term neurologic outcome compared to placebo in patients with moderate to severe TBI who are not in shock. This study protocol will be conducted as part of the Resuscitation Outcomes Consortium (ROC) at trauma centers in the United States and Canada. ROC is funded by the National Heart Lung and Blood Institute (NHLBI) in partnership with the US Army Medical Research and Materiel Command (USAMRMC), Canadian Institutes of Health Research, the Heart \& Stroke Foundation of Canada, the American Heart Association (AHA), and the Defense Research and Development Canada. ROC is a clinical trials network focusing on research primarily in the area of prehospital cardiopulmonary arrest and severe traumatic injury. The mission of ROC is to provide infrastructure and project support for clinical trials and other outcome-oriented research in the areas of cardiopulmonary arrest and severe traumatic injury that lead to evidence-based change in clinical practice.
  2. Specific Aims/Hypothesis Statement 2.1 Clinical Hypotheses and Aims Specific aim 1: To compare 6-month neurologic outcome between subjects who are randomly assigned to TXA to subjects who are randomly assigned to placebo by evaluating the Glasgow Outcome Scale Extended score (GOS-E) at 6 months post-injury. Primary Hypotheses: We will perform a one-sided test of the following null hypothesis: The proportion of subjects who have a favorable neurologic outcome (GOS-E > 4) at six months post injury who are randomly assigned to TXA is not different from the proportion of subjects who have a favorable neurologic outcome (GOS-E > 4) who are randomly assigned to placebo. This hypothesis will be tested versus the alternative that the proportion of subjects with a favorable neurologic outcome who are randomly assigned to TXA is higher than in subjects who are randomly assigned to placebo at the .1 level and versus the alternative that the proportion of subjects with a favorable neurologic outcome who are randomly assigned to TXA is lower than it is in the placebo group at the .025 level Specific aim 2: To assess differences in morbidity and mortality measured from randomization through 28 days or initial hospital discharge and differences in neurologic outcomes at 6 months between subjects in the bolus/maintenance arm, bolus only arm, and placebo arm. Secondary Hypotheses: The null hypotheses are that there will be no difference between subjects who are randomly assigned to TXA and subjects who are randomly assigned to placebo in the following: both absolute and relative volume of intracranial hemorrhage (ICH) progression, proportion of subjects with ICH progression, frequency of neurosurgical interventions, GOS-E measured at discharge and 6 months, Disability Rating Scale score (DRS) measured at discharge and 6 months, 28-day survival, and ventilator-free, intensive care unit (ICU)-free, and hospital-free days. Specific aim 3: To assess differences in adverse events measured from randomization to initial hospital discharge between subjects in the bolus/maintenance arm, bolus only arm, and placebo arm. Tertiary Hypotheses: The null hypotheses are that there will be no difference between subjects who are randomly assigned to TXA and subjects who are randomly assigned to placebo in the following: proportion of subjects experiencing seizures, cerebral ischemic events, myocardial infarction (MI), deep venous thrombosis (DVT), or pulmonary thromboembolism (PE) post randomization through 28 days or discharge, whichever occurs first. 2.2 Laboratory Hypotheses and Aims Specific aim 1: To compare coagulation profiles over time using kaolin activated thrombelastography (TEG) results between subjects who are randomly assigned to TXA and subjects who are randomly assigned to placebo. Primary hypothesis: The null hypothesis is that there will be no difference in the degree of fibrinolysis as assessed by percentage of clot lysis determined 30 minutes after the maximum amplitude is reached (LY30) between subjects who are randomly assigned to TXA and subjects who are randomly assigned to placebo. Specific aim 2: To explore the underlying mechanism of TXA by comparing fibrinolytic pathway mediator activity between subjects who are randomly assigned to TXA and subjects who are randomly assigned to placebo. Secondary hypothesis: The null hypothesis is that there will be no change in fibrinolytic pathway mediators between subjects who are randomly assigned to TXA and subjects who are randomly assigned to placebo. Specific aim 3: To estimate the association between the degree of fibrinolysis based on kaolin activated TEG results and fibrinolytic pathway mediators on primary and secondary clinical outcomes. Tertiary hypothesis: The null hypothesis is that no association will exist between the degree of fibrinolysis and fibrinolytic pathway mediators and primary and secondary clinical outcomes.
  3. Study Enrollment EMS agencies will carry blinded sealed study drug kits. Once the seal is broken in the presence of the patient, the patient is randomized. The EMS study drug kit will contain a vial of either 1 gram TXA, 2 grams TXA, or placebo. EMS will mix the study drug in a 250 mL bag of 0.9% sodium chloride and administer the bolus infusion as soon as life-saving interventions are performed. After randomization, EMS will provide the study drug kit ID# to the receiving pharmacy. The hospital pharmacist will obtain the randomization assignment from the coordinating center and prepare the appropriate drug to be administered in the hospital.
  4. Sample Size and Statistical Analysis The total sample size is 963 (321 per group) starting treatment, which will allow for 80% power to detect a 7.1% absolute difference in favorable long-term neurological outcome as determined by the GOS-E 6 months after injury comparing the combined TXA treatment groups to placebo, using a one-sided, level 0.1 test. Statistical analysis of primary hypothesis: Modified intention-to-treat analysis using logistic regression to test for association and estimate the strength of the association of treatment group with a favorable 6-month outcome (defined as a GOS-E > 4), after adjustment for study site.
  5. Human subjects protection

This study qualifies for the exception from informed consent (EFIC) required for emergency research outlined in FDA regulation 21CFR50.24. EFIC applies because of life-threatening situation, intervention must be administered before consent is feasible, no reasonable way to identify prospectively individuals at risk, patients have the prospect of benefit from the treatment, and the research could not practically be carried out without the waiver of consent.

Being tested
1 gram Tranexamic Acid (TXA), 2 grams TXA, 0.9% Sodium Chloride injectable
Keywords
tranexamic acid, traumatic brain injury, intracranial hemorrhage, prehospital, neurologic outcome, glasgow outcome scale extended, disability rating scale
Medical subject headings
Brain Injuries, Traumatic, Intracranial Hemorrhages

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 1 gram Tranexamic Acid (TXA)Drug

    Also called Cyklokapron

    TXA produces an antifibrinolytic effect by competitively inhibiting the activation of plasminogen to plasmin.

  • 2 grams TXADrug

    Also called Cyklokapron

    TXA produces an antifibrinolytic effect by competitively inhibiting the activation of plasminogen to plasmin.

  • 0.9% Sodium Chloride injectableDrug

    Also called Normal saline solution

    Loading dose of 0.9% Sodium Chloride solution given prior to hospital arrival followed by a placebo of 0.9% Sodium Chloride solution infusion over 8 hours after hospital arrival. No active drug is added to the solution.

Study groups in NCT01990768
Study groupRoleWhat they receive
1 gram Tranexamic Acid (TXA)ExperimentalLoading dose of 1 gram TXA given prior to hospital arrival followed by a 1 gram TXA infusion over 8 hours after hospital arrival
Receives: Drug: 1 gram Tranexamic Acid (TXA)
2 grams TXAExperimentalLoading dose of 2 gram TXA given prior to hospital arrival followed by a placebo of 0.9% Sodium Chloride solution infusion over 8 hours after hospital arrival
Receives: Drug: 2 grams TXA
0.9% Sodium Chloride injectablePlacebo comparatorLoading dose of 0.9% Sodium Chloride solution given prior to hospital arrival followed by a placebo of 0.9% Sodium Chloride solution infusion over 8 hours after hospital arrival
Receives: Drug: 0.9% Sodium Chloride injectable

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dichotomized Glasgow Outcome Scale Extended (GOS-E) at 6 Months

    GOS-E subdivides the categories of severe and moderate disability and good recovery using a scale of 1 to 8 where 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, and 8 = upper good recovery. Structured telephone interviews have been developed and validated for the GOS-E and these questions were incorporated into the follow-up survey. GOS-E was dichotomized into unfavorable (1 to 4) and favorable (5 to 8) outcomes.

    Measured: 6 months post-injury

Secondary outcomes (17)

  1. Number of Participants Who Died Within 28 Days

    The counts of patients who died on or before day 28 are reported.

    Measured: 28 days after hospital arrival

  2. Disability Rating Scale (DRS) at 6 Months

    The DRS is designed to classify patients based on their degree of function after brain injury. The DRS consists of 8 items that fall into 4 categories: (a) arousability, awareness and responsivity, (b) cognitive ability for self-care activities, (c) dependence on others, and (d) psychosocial adaptability. The score ranges from 0 (no disability) to 30 (death).

    Measured: 6 months post-injury

  3. Number of Participants With Unfavorable Outcome on Dichotomized Glasgow Outcome Scale Extended (GOS-E) at Discharge

    GOS-E subdivides the categories of severe and moderate disability and good recovery using a scale of 1 to 8 where 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, and 8 = upper good recovery. Structured telephone interviews have been developed and validated for the GOS-E and these questions were incorporated into the follow-up survey. GOS-E was dichotomized into unfavorable (1 to 4) and favorable (5 to 8) outcomes. The number of subjects with unfavorable outcome is reported.

    Measured: At the end of the hospital stay (average of 9 days post injury)

  4. Disability Rating Scale (DRS) at Discharge

    The DRS is designed to classify patients based on their degree of function after brain injury. The DRS consists of 8 items that fall into 4 categories: (a) arousability, awareness and responsivity, (b) cognitive ability for self-care activities, (c) dependence on others, and (d) psychosocial adaptability. The score ranges from 0 (no disability) to 30 (death).

    Measured: At the end of the hospital stay (average of 9 days post injury)

  5. Number of Participants With Intracranial Hemorrhage (ICH) Progression

    All clinically indicated head computed tomography (CT) scans obtained during the initial hospitalization or within the first 28 days were assessed for ICH. Parenchymal (IPH), subdural (SDH) and epidural (EDH) hemorrhage volumes were measured and quantified using volumetric software and verified by manual calculations based on the previously validated ABC/2 technique. The sum of the IPH, SDH, and EDH volumes were compared across scans. A relative increase of 33% (and at least a 1 ml increase) on any subsequent scan compared to the initial scan was defined as a progression.

    Measured: From hospital admission through 28 days or the end of the hospital stay if sooner (average of 13 days among patients with multiple scans)

  6. Marshall Computed Tomography (CT) Score on Initial Head CT

    The Marshall classification categorizes patients into one of six categories (I to VI) of increasing severity on the basis of findings on non-contrast CT scan of the brain. Higher categories have worse prognosis and survival.

    Measured: Initial head CT (average of 1.9 hours post-injury)

  7. Rotterdam Computed Tomography (CT) Score Among Subjects With Intracranial Hemorrhage (ICH) on Initial Head CT

    The Rotterdam classification includes four independently scored elements: degree of basal cistern compression, degree of midline shift, presence of epidural hematomas, and presence of intraventricular or subarachnoid blood. The elements are combined to form an overall score from 1 to 6 with higher scores having worse prognosis and survival.

    Measured: Initial head CT (average of 1.9 hours post-injury)

  8. Number of Participants With One or More Neurosurgical Interventions

    Neurosurgical interventions include craniotomy, craniectomy, and placement of a neuromonitoring or drainage device. Counts are of subjects with one or more neurosurgical interventions.

    Measured: From hospital admission through 28 days or the end of the hospital stay if sooner (average of 9 days)

  9. Hospital-free Days

    Hospital-free days count any day from hospital admission through day 28 that the patient is alive and out of the hospital.

    Measured: From hospital admission through day 28

  10. Intensive Care Unit (ICU)-Free Days

    ICU-free days count any day from hospital admission through day 28 that the patient is alive and not in the ICU. Subjects who die prior to discharge (even if after 28 days) are assigned a value of 0.

    Measured: From hospital admission through day 28

  11. Ventilator-free Days

    Ventilator-free days count any day from hospital admission through day 28 that the patient is alive and does not require mechanical ventilatory support. Subjects who die prior to discharge (even if after 28 days) are assigned a value of 0.

    Measured: From hospital admission through day 28

  12. Number of Participants With Seizure

    Seizures may cause involuntary changes in body movement or function, sensation, awareness, or behavior. Seizures are often associated with a sudden and involuntary contraction of a group of muscles and loss of consciousness. Seizures or episodes of seizure-like activity were reported by medics in the field following the start of study drug infusion through hand-off to the trauma center and by trauma center staff through discharge. Reported events were included if providers gave anti-seizure medication and/or the event was confirmed by EEG.

    Measured: From start of study drug infusion through 28 days or the end of the hospital stay if sooner (average of 9 days)

  13. Number of Participants With Cerebral Ischemic Event

    Diagnosis of cerebral ischemic event

    Measured: From hospital admission through 28 days or the end of the hospital stay if sooner (average of 9 days)

  14. Number of Participants With Myocardial Infarction (MI)

    Diagnosis of an acute myocardial infarction

    Measured: From hospital admission through 28 days or the end of the hospital stay if sooner (average of 9 days)

  15. Number of Participants With Deep Vein Thrombosis (DVT)

    Diagnosis of DVT

    Measured: From hospital admission through 28 days or the end of the hospital stay if sooner (average of 9 days)

  16. Number of Participants With Pulmonary Embolus (PE)

    Diagnosis of PE

    Measured: From hospital admission through 28 days or the end of the hospital stay if sooner (average of 9 days)

  17. Number of Participants With Any Thromboembolic Event

    Diagnosis of one or more of the following: cerebral ischemic event, myocardial infarction (MI), deep vein thrombosis (DVT), pulmonary embolism (PE), or any other thromboembolic event

    Measured: From hospital admission through 28 days or the end of the hospital stay if sooner (average of 9 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2013 (estimated)
  2. Study startMay 2015
  3. Primary completion7 Nov 2017
  4. Study completion7 Nov 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
967 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01990768
Sponsor's protocol ID
47114
Other IDs
5U01HL077863-09, TATRC Log No. 13335004-A
Acronym
TXA
Status last verified
Dec 2018
First submitted
30 Oct 2013
Last updated
14 Jan 2019
Data monitoring committee
Yes
Individual data sharing
Yes: Public use data set will be shared with NHLBI. It will include individual patient data that are de-identified. It will be available 3 years after study completion. This is currently expected for the end of 2020. The data should then be available at \<https://biolincc.nhlbi.nih.gov/studies/\>.

Publications

  • Minoza KG, Brito AM, Loss L, McLoud S, Kenny JEH, McLean WJ, Papa L, Rowell S, Schreiber M. Association between coagulation biomarkers, intracranial hemorrhage types, and tranexamic acid treatments in early traumatic brain injury. J Trauma Acute Care Surg. 2025 Sep 1;99(3):468-476. doi: 10.1097/TA.0000000000004669. Epub 2025 Jun 10.

    PubMed 40490870

  • Newman ZC, Ogbeifun VO, Barbosa CE, McKinley WI, Benjamin AJ, Munar MY, Pramuka PE, McGovern KD, Nordgren RK, Schreiber MA, Rowell SE. Intravenous Versus Intraosseous Use of Tranexamic Acid in Patients With Traumatic Brain Injury. J Surg Res. 2024 Oct;302:798-804. doi: 10.1016/j.jss.2024.08.003. Epub 2024 Sep 2.

    PubMed 39226704

  • Rowell S, Meier EN, Hoyos Gomez T, Fleming M, Jui J, Morrison L, Bulger E, Sopko G, Weisfeldt M, Christenson J, Klotz P, McMullan J, Callum J, Sheehan K, Tibbs B, Aufderheide T, Cotton B, Gandhi R, Idris A, Frascone RJ, Ferrara M, Richmond N, Kannas D, Schlamp R, Robinson B, Dries D, Tallon J, Hendrickson A, Gamber M, Garrett J, Simonson R, McKinley WI, Schreiber M. The effects of prehospital TXA on mortality and neurologic outcomes in patients with traumatic intracranial hemorrhage: A subgroup analysis from the prehospital TXA for TBI trial. J Trauma Acute Care Surg. 2024 Oct 1;97(4):572-580. doi: 10.1097/TA.0000000000004354. Epub 2024 Apr 30.

    PubMed 38685481

  • Hoefer LE, Benjamin AJ, Polcari AM, Schreiber MA, Zakrison TL, Rowell SE. TXA does not affect levels of TBI-related biomarkers in blunt TBI with ICH: A secondary analysis of the prehospital TXA for TBI trial. J Trauma Acute Care Surg. 2024 Jan 1;96(1):94-100. doi: 10.1097/TA.0000000000004130. Epub 2023 Oct 9.

    PubMed 37807179

  • Harmer JW, Dewey EN, Meier EN, Rowell SE, Schreiber MA. Tranexamic acid is not inferior to placebo with respect to adverse events in suspected traumatic brain injury patients not in shock with a normal head computed tomography scan: A retrospective study of a randomized trial. J Trauma Acute Care Surg. 2022 Jul 1;93(1):98-105. doi: 10.1097/TA.0000000000003635. Epub 2022 Mar 28.

    PubMed 35358154

  • Rowell SE, Meier EN, McKnight B, Kannas D, May S, Sheehan K, Bulger EM, Idris AH, Christenson J, Morrison LJ, Frascone RJ, Bosarge PL, Colella MR, Johannigman J, Cotton BA, Callum J, McMullan J, Dries DJ, Tibbs B, Richmond NJ, Weisfeldt ML, Tallon JM, Garrett JS, Zielinski MD, Aufderheide TP, Gandhi RR, Schlamp R, Robinson BRH, Jui J, Klein L, Rizoli S, Gamber M, Fleming M, Hwang J, Vincent LE, Williams C, Hendrickson A, Simonson R, Klotz P, Sopko G, Witham W, Ferrara M, Schreiber MA. Effect of Out-of-Hospital Tranexamic Acid vs Placebo on 6-Month Functional Neurologic Outcomes in Patients With Moderate or Severe Traumatic Brain Injury. JAMA. 2020 Sep 8;324(10):961-974. doi: 10.1001/jama.2020.8958.

    PubMed 32897344

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 1 gram Tranexamic Acid (TXA), 2 grams TXA and 0.9% Sodium Chloride injectable in people with Traumatic Brain Injury, run by University of Washington at 12 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dichotomized Glasgow Outcome Scale Extended (GOS-E) at 6 Months (time frame: 6 months post-injury). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01990768, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2019.

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