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Prehospital Tranexamic Acid Use for Traumatic Brain Injury (TXA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01990768
Recruitment Status : Completed
First Posted : November 21, 2013
Results First Posted : January 14, 2019
Last Update Posted : January 14, 2019
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
U.S. Army Medical Research and Development Command
Canadian Institutes of Health Research (CIHR)
Heart and Stroke Foundation of Canada
American Heart Association
Defence Research and Development Canada
Information provided by (Responsible Party):
Susanne May, University of Washington

Tracking Information
First Submitted Date  ICMJE October 30, 2013
First Posted Date  ICMJE November 21, 2013
Results First Submitted Date  ICMJE November 7, 2018
Results First Posted Date  ICMJE January 14, 2019
Last Update Posted Date January 14, 2019
Study Start Date  ICMJE May 2015
Actual Primary Completion Date November 7, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 31, 2018)
Dichotomized Glasgow Outcome Scale Extended (GOS-E) at 6 Months [ Time Frame: 6 months post-injury ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 15, 2013)
Glasgow Outcome Scale Extended score (GOS-E) [ Time Frame: 6 months post-injury ]
GOS-E subdivides the categories of severe and moderate disability and good recovery. Structured telephone interviews have been developed and validated for both the GOS and GOS-E and these questions will be incorporated into our follow-up survey. For each level of function, the baseline function prior to injury is assessed to ensure that the deficit can be attributed to the event.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 31, 2018)
  • Number of Participants Who Died Within 28 Days [ Time Frame: 28 days after hospital arrival ]
    The counts of patients who died on or before day 28 are reported.
  • Disability Rating Scale (DRS) at 6 Months [ Time Frame: 6 months post-injury ]
    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).
  • Number of Participants With Unfavorable Outcome on Dichotomized Glasgow Outcome Scale Extended (GOS-E) at Discharge [ Time Frame: At the end of the hospital stay (average of 9 days post injury) ]
    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.
  • Disability Rating Scale (DRS) at Discharge [ Time Frame: At the end of the hospital stay (average of 9 days post injury) ]
    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).
  • Number of Participants With Intracranial Hemorrhage (ICH) Progression [ Time Frame: From hospital admission through 28 days or the end of the hospital stay if sooner (average of 13 days among patients with multiple scans) ]
    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.
  • Marshall Computed Tomography (CT) Score on Initial Head CT [ Time Frame: Initial head CT (average of 1.9 hours post-injury) ]
    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.
  • Rotterdam Computed Tomography (CT) Score Among Subjects With Intracranial Hemorrhage (ICH) on Initial Head CT [ Time Frame: Initial head CT (average of 1.9 hours post-injury) ]
    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.
  • Number of Participants With One or More Neurosurgical Interventions [ Time Frame: From hospital admission through 28 days or the end of the hospital stay if sooner (average of 9 days) ]
    Neurosurgical interventions include craniotomy, craniectomy, and placement of a neuromonitoring or drainage device. Counts are of subjects with one or more neurosurgical interventions.
  • Hospital-free Days [ Time Frame: From hospital admission through day 28 ]
    Hospital-free days count any day from hospital admission through day 28 that the patient is alive and out of the hospital.
  • Intensive Care Unit (ICU)-Free Days [ Time Frame: From hospital admission through day 28 ]
    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.
  • Ventilator-free Days [ Time Frame: From hospital admission through day 28 ]
    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.
  • Number of Participants With Seizure [ Time Frame: From start of study drug infusion through 28 days or the end of the hospital stay if sooner (average of 9 days) ]
    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.
  • Number of Participants With Cerebral Ischemic Event [ Time Frame: From hospital admission through 28 days or the end of the hospital stay if sooner (average of 9 days) ]
    Diagnosis of cerebral ischemic event
  • Number of Participants With Myocardial Infarction (MI) [ Time Frame: From hospital admission through 28 days or the end of the hospital stay if sooner (average of 9 days) ]
    Diagnosis of an acute myocardial infarction
  • Number of Participants With Deep Vein Thrombosis (DVT) [ Time Frame: From hospital admission through 28 days or the end of the hospital stay if sooner (average of 9 days) ]
    Diagnosis of DVT
  • Number of Participants With Pulmonary Embolus (PE) [ Time Frame: From hospital admission through 28 days or the end of the hospital stay if sooner (average of 9 days) ]
    Diagnosis of PE
  • Number of Participants With Any Thromboembolic Event [ Time Frame: From hospital admission through 28 days or the end of the hospital stay if sooner (average of 9 days) ]
    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
Original Secondary Outcome Measures  ICMJE
 (submitted: November 15, 2013)
  • Observed volume (absolute and relative) of intracranial hemorrhage (ICH) progression [ Time Frame: On hospital arrival through 28 days or from hospital admission through the end of the hospital stay, an expected average of 14 days post injury ]
    All clinically indicated head CT scans obtained during the initial hospitalization or within the first 28 days will be assessed for ICH. All cerebral and carotid/vertebrobasilar CT and standard angiograms will be assessed for blunt cerebrovascular injury. Parenchymal, subdural and epidural hemorrhage volumes will be measured and quantified using volumetric software and verified by manual calculations based on the previously validated ABC/2 technique as needed.
  • Disability Rating Scale (DRS) [ Time Frame: At the end of the hospital stay, an expected average of 14 days post injury, and 6 months post injury ]
    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 3) psychosocial adaptability.
  • GOS-E [ Time Frame: At the end of the hospital stay, an expected average of 14 days post injury ]
    GOS-E subdivides the categories of severe and moderate disability and good recovery. Structured telephone interviews have been developed and validated for both the GOS and GOS-E and these questions will be incorporated into our follow-up survey. For each level of function, the baseline function prior to injury is assessed to ensure that the deficit can be attributed to the event.
  • Survival [ Time Frame: 28 days after hospital arrival ]
    The patient's vital status as either alive or dead at 28 days after hospital arrival.
  • Frequency of neurosurgical interventions [ Time Frame: From hospital admission through the end of the hospital stay, an expected average of 14 days post injury ]
    Neurosurgical interventions are surgical procedures required to treat traumatic brain injury.
  • Ventilator-free Days [ Time Frame: From hospital admission through day 28 ]
    Ventilator-free days count any day from hospital admission through day 28 that the patient does not require mechanical ventilatory support.
  • Seizure [ Time Frame: From hospital admission through the end of the hospital stay, an expected average of 14 days post injury ]
    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.
  • Cerebral ischemic events [ Time Frame: From hospital admission through the end of the hospital stay, an expected average of 14 days post injury ]
    New focal ischemic lesions will be defined as an area of focal low attenuation in a distribution indicating an arterial ischemic cause rather than a traumatic contusion and will be rated using a validated scale for ischemic stroke.
  • Myocardial infarction [ Time Frame: From hospital admission through the end of the hospital stay, an expected average of 14 days post injury. ]
    Diagnosis of an acute myocardial infarction
  • Deep vein thrombosis (DVT) [ Time Frame: From hospital admission through the end of the hospital stay, an expected average of 14 days post injury ]
    Diagnosis of an DVT
  • Pulmonary embolus (PE) [ Time Frame: From hospital admission through the end of the hospital stay, an expected average of 14 days post injury ]
    Diagnosis of PE
Current Other Pre-specified Outcome Measures
 (submitted: December 31, 2018)
Fibrinolysis at Hospital Admission [ Time Frame: First blood draw (average of 1.6 hours post-injury) ]
Alterations in fibrinolysis based on fibrinolytic pathway mediators and degree of clot lysis based on kaolin-activated thromboelastography (TEG) and defined as LY30 or the per cent lysis that occurs 30 minutes after maximum amplitude (MA) is achieved. LY30 is categorized as <0.8% (fibrinolysis shutdown), 0.8-3% (normal), and >3% (hyperfibrinolysis).
Original Other Pre-specified Outcome Measures
 (submitted: November 15, 2013)
Alterations in fibrinolysis [ Time Frame: From hospital admission through 48 hours ]
Alterations in fibrinolysis based on fibrinolytic pathway mediators and degree of clot lysis based on kaolin activated TEG and defined as LY30 or the per cent lysis that occurs 30 minutes after maximum amplitude (MA) is achieved.
 
Descriptive Information
Brief Title  ICMJE Prehospital Tranexamic Acid Use for Traumatic Brain Injury
Official Title  ICMJE Prehospital Tranexamic Acid Use for Traumatic Brain Injury
Brief 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 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.

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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Traumatic Brain Injury
Intervention  ICMJE
  • Drug: 1 gram Tranexamic Acid (TXA)
    TXA produces an antifibrinolytic effect by competitively inhibiting the activation of plasminogen to plasmin.
    Other Name: Cyklokapron
  • Drug: 2 grams TXA
    TXA produces an antifibrinolytic effect by competitively inhibiting the activation of plasminogen to plasmin.
    Other Name: Cyklokapron
  • Drug: 0.9% Sodium Chloride injectable
    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.
    Other Name: Normal saline solution
Study Arms  ICMJE
  • Experimental: 1 gram Tranexamic Acid (TXA)
    Loading dose of 1 gram TXA given prior to hospital arrival followed by a 1 gram TXA infusion over 8 hours after hospital arrival
    Intervention: Drug: 1 gram Tranexamic Acid (TXA)
  • Experimental: 2 grams TXA
    Loading 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
    Intervention: Drug: 2 grams TXA
  • Placebo Comparator: 0.9% Sodium Chloride injectable
    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
    Intervention: Drug: 0.9% Sodium Chloride injectable
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 5, 2017)
967
Original Estimated Enrollment  ICMJE
 (submitted: November 15, 2013)
1002
Actual Study Completion Date  ICMJE November 7, 2017
Actual Primary Completion Date November 7, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  1. Prehospital GCS=3 with no reactive pupil
  2. Estimated time from injury to hospital arrival > 2 hours
  3. Unknown time of injury - no known reference times to support estimation
  4. Clinical suspicion by EMS of seizure activity or known history of seizures, acute myocardial infarction (MI) or stroke
  5. Cardio-pulmonary resuscitation (CPR) by EMS prior to randomization
  6. Burns > 20% total body surface area (TBSA)
  7. Suspected or known prisoners
  8. Suspected or known pregnancy
  9. Prehospital TXA given prior to randomization
  10. Subjects who have activated the "opt-out" process when required by the local regulatory board
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01990768
Other Study ID Numbers  ICMJE 47114
5U01HL077863-09 ( U.S. NIH Grant/Contract )
TATRC Log No. 13335004-A ( Other Grant/Funding Number: US Army Medical Research Acquisition Activity (USAMRAA) )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: 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/>.
Responsible Party Susanne May, University of Washington
Study Sponsor  ICMJE University of Washington
Collaborators  ICMJE
  • National Heart, Lung, and Blood Institute (NHLBI)
  • U.S. Army Medical Research and Development Command
  • Canadian Institutes of Health Research (CIHR)
  • Heart and Stroke Foundation of Canada
  • American Heart Association
  • Defence Research and Development Canada
Investigators  ICMJE
Principal Investigator: Susanne May, PhD University of Washington
Principal Investigator: Martin Schreiber, MD FACS Oregon Health and Science University
PRS Account University of Washington
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP