HemorrhagePhase 2TAMPITINCT02535949
Tranexamic Acid Mechanisms and Pharmacokinetics in Traumatic Injury
A Phase 2 study testing Tranexamic Acid in people with Hemorrhage and Shock, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effects of TXA on the immune system, its pharmacokinetics, as well as safety and efficacy in severely injured trauma patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemorrhage, Shock, Wounds and Injuries
- What is being tested?
- Tranexamic Acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to 7 Jul 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with traumatic injury that are ordered to receive at least 1 blood product and/or
- Patients admitted to the Emergency Department with a traumatic injury and require immediate transfer to the operating room to control the bleeding
- Able to receive the study drug within 2 hours from estimated time of injury **Please note that in circumstances where the patient initially met inclusion/exclusion criteria (i.e. received blood products in the ED before a full evaluation of their injuries is complete) but is later found to only have a soft tissue involved injury or does not have a traumatic bleeding source), the Investigator may determine that the patient should not be randomized into the trial and the patient should be considered a screen failure
Who cannot join
- Patients known to be < 18 years of age
- Suspected Acute MI or stroke(thromboembolic and/or hemorrhagic) on admission
- Known inherited coagulation disorders
- Known history of thromboembolic events (DVT, PE, MI, Stroke)
- Please note that past medical history of hemorrhagic stroke is permitted, but not current admission with hemorrhagic stroke
- Known history of seizures and/or seizure after injury/on admission related to this hospitalization
Show all 13Show fewer
- Suspected or known pregnancy
- Known to be lactating
- Suspected or known prisoners
- Futile care
- Known current state of immunosuppression (i.e. on high dose steroids, chemotherapeutics, etc.)
- Unknown estimated time of injury 12). Patients wearing an "Opt Out" TAMPITI Study bracelet 13). Known presence of subarachnoid hemorrhage.
- 14.) Isolated injuries to hands and/or feet (distal) 15.) Administration of antifibrinolytics pre-hospital and/or during this ED admission prior to enrollment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tranexamic Acid Mechanisms and Pharmacokinetics in Traumatic Injury (TAMPITI TRIAL)
The purpose of this study is to evaluate the effects of TXA on the immune system, its pharmacokinetics, as well as safety and efficacy in severely injured trauma patients.
Read the detailed description
Trauma is the leading cause of death in persons younger than 40 years. Hemorrhage is the etiology in 30% of these deaths, and remains the leading cause of potentially preventable mortality (66-80%) on the battlefield. Death secondary to hemorrhagic shock occurs from both surgical bleeding and coagulopathy. Due to the knowledge of increased fibrinolysis promoting a hypocoagulable state in severe trauma, trials have been performed to determine if antifibrinolytics such as tranexamic acid (TXA) could reduce morbidity and mortality by reducing death from hemorrhage. TXA is an antifibrinolytic that inhibits both plasminogen activation and plasmin activity, thus preventing clot break-down rather than promoting new clot formation. Despite the extensive use of TXA in many surgical populations and an increasing use in severe trauma patients, TXA does not have an FDA approved indication for patients with traumatic injuries. The effect of TXA on immune function has not been thoroughly examined, especially in patients with severe traumatic injury. The study of the effects of TXA use on endothelial activation and injury is also important due to the inter-relationship between coagulation and endothelial function. Endothelial injury secondary to local hypoperfusion causes acute traumatic coagulopathy with fibrinolysis. Therefore a thorough and comprehensive evaluation of the effects of TXA on immune, coagulation, and endothelial parameters is important to allow for a better understanding of the mechanisms of action of this agent.
This is a randomized placebo controlled trial to obtain mechanism of action data, pharmacokinetic information, and efficacy and safety data for the use of TXA in severely injured trauma patients. Participants will be randomized into 1 of 3 treatment arms (1:1:1): TXA 2 gram IV bolus, TXA 4 gram IV bolus, or placebo. The study period is from time of enrollment to hospital discharge or transfer. The study intervention will occur only once upon enrollment in the trial. Participants will receive study drug within two hours from their initial injury. Blood samples will be drawn at multiple time points for immune parameters, Pharmacodynamics, and repository samples.
Immune parameter samples will be drawn at at approximately 0, 6, 24 and 72 hours after study drug/placebo administration.
Pharmacokinetic and pharmacodynamic samples will be drawn according to two schedules. Even number sampling times, blood will be drawn at the approximate time points: 0, 20 min, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, and 12 hr. A patient sampled on odd number sampling times will have samples drawn at the approximate time points: 0, 10 min, 40 min, 1.5 hr, 3 hr, 6 hr, 10 hr and 24 hr.
Repository samples will be drawn at approximate time points: 0, 1, 6, 24, and 72 hours.
- Conditions
- Hemorrhage, Shock, Wounds and Injuries
- Being tested
- Tranexamic Acid, Placebo
- Medical subject headings
- Hemorrhage, Shock, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
Also called Cyklokapron
Tranexamic acid is a man-made form of an amino acid (protein) called lysine. Tranexamic acid prevents enzymes in the body from breaking down blood clots.
PlaceboOther
Matching Volume Normal Saline Placebo given IV over 10 minutes within 2 hours of initial injury
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic Acid 2 Gram | Experimental | One time dose IV TXA 2 Grams given over 10 minutes within 2 hours of initial injury Receives: Drug: Tranexamic Acid |
| Tranexamic Acid 4 Gram | Experimental | One time dose IV TXA 4 Grams given over 10 minutes within 2 hours of initial injury Receives: Drug: Tranexamic Acid |
| Placebo | Placebo comparator | Matching Volume Normal Saline Placebo given IV over 10 minutes within 2 hours of initial injury Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HLA-DR Expression on Monocytes 72 Hours After Drug or Placebo Administration in Patient Groups (0g TXA (Placebo); 2g TXA; 4g TXA)."
Blood was drawn from patients at baseline (0 h, just before placebo or drug administration) and at 72 hours post placebo or drug administration. Leukocytes in these blood samples were stained with fluroescent antibodies specific for CD45, CD14, and HLA-DR, analyzed by flow cytometry, and the median fluorescen intensity (MFI) of HLA-DR signal was recorded for monocytes (CD45+CD14+). The fold change in HLA-DR expression from prior to placebo/drug administration to 72 h after placebo/drug administration ("0 h : 72 h") was calculated as HLA-DR MFI72hours ÷ HLA-DR CD14 MFI0hours. Non-paramteric one-way ANOVA (Kruskal-Wallis test) was performed between each treatment group at the given time pont, and the p-value reported.
Measured: Samples Drawn through 72 hours after study initiation
Secondary outcomes (13)
Differences in Cytokine Profiles Between the Three Study Groups
To evaluate the effects of TXA on immune function parameters we will, in a RCT, analyze samples from 150 patients (50 in each study group), at multiple time points. Parameters are:
- Cytokines measured from time 0 to 72 hours.
Measured: Samples Drawn through 72 hours after study initiation
Differences in Leukocyte Function Parameters Between the Three Study Groups
To evaluate the effects of TXA on immune function parameters we will, in a RCT, analyze samples from 150 patients (50 in each study group), at multiple time points. Parameters are:
- Flow cytometric analyses on leukocytes measured from time 0 to 72 hours.
Measured: Samples Drawn through 72 hours after study initiation
Total Transfusion Volume CL
Pharmacokinetic data was analyzed with NONMEM, using both the first-order and conditional non-Laplacian (with centering) estimation techniques. We considered two- and three-compartment models, parameterized in terms of both compartment volumes and clearances (distribution and elimination). We compared a basic model (in which pharmacokinetic parameters were independent of weight) to a model in which the pharmacokinetic parameters were assumed to be proportional to weight. The optimal model was selected on the basis of the objective function logarithm of the likelihood of the results) using standard criteria (NONMEM guide).
Equations from optimal model:
CL=109*((WT/70)0.75) * (SCRint^-0.084) * ((NIRSInt)/96)^ -0.27 ) * ((PLTint)/130)^0.45) V1=1,160*(WT/70) * (TxTot)^0.03) Q=174*((WT/70)0.75) V2=1080 *(WT/70)
"Total Transfusion Volume CL" equals clearance (CL) affected by the covariate of Total Transfusion Volume (TxTot). This value is unitless per NONMEM reporting.
Measured: 24 hours
Determine the Incidence of Thromboembolic Events (DVT, MI, PE, Stroke) in All Three Study Groups.
The number of events per group for the incidence of thromboembolic events (DVT, MI, PE, Stroke) in all three study groups.
Measured: Hospital Discharge (average 10 days)
Determine the Incidence of Seizures at 24 Hours in All Three Study Groups.
The incidence of seizures at 24 hours in all three study groups. Number of participants with seizures are reported
Measured: 24 hours following TXA
Determine the Incidence of All Adverse Events in All Three Study Groups
All adverse events were totaled for each of the three study groups based on the number of incidents.
Measured: Hospital Discharge (average 10 days)
Platelet Count CL
Pharmacokinetic data was analyzed with NONMEM, using both the first-order and conditional non-Laplacian (with centering) estimation techniques. We considered two- and three-compartment models, parameterized in terms of both compartment volumes and clearances (distribution and elimination). We compared a basic model (in which pharmacokinetic parameters were independent of weight) to a model in which the pharmacokinetic parameters were assumed to be proportional to weight. The optimal model was selected on the basis of the objective function logarithm of the likelihood of the results) using standard criteria (NONMEM guide).
Equations from optimal model:
CL=109*((WT/70)0.75) * (SCRint^-0.084) * ((NIRSInt)/96)^ -0.27 ) * ((PLTint)/130)^0.45) V1=1,160*(WT/70) * (TxTot)^0.03) Q=174*((WT/70)0.75) V2=1080 *(WT/70)
"Platelet Count CL" equals clearance (CL) affected by the covariate of Platelet Count (PLTint). This value is unitless per NONMEM reporting.
Measured: 24 hours
Near Infrared Spectroscopy CL
Pharmacokinetic data was analyzed with NONMEM, using both the first-order and conditional non-Laplacian (with centering) estimation techniques. We considered two- and three-compartment models, parameterized in terms of both compartment volumes and clearances (distribution and elimination). We compared a basic model (in which pharmacokinetic parameters were independent of weight) to a model in which the pharmacokinetic parameters were assumed to be proportional to weight. The optimal model was selected on the basis of the objective function logarithm of the likelihood of the results) using standard criteria (NONMEM guide).
Equations from optimal model:
CL=109*((WT/70)0.75) * (SCRint^-0.084) * ((NIRSInt)/96)^ -0.27 ) * ((PLTint)/130)^0.45) V1=1,160*(WT/70) * (TxTot)^0.03) Q=174*((WT/70)0.75) V2=1080 *(WT/70)
"Near Infrared Spectroscopy CL" equals clearance (CL) affected by the covariate of Near Infrared Spectroscopy (NIRSint). This value is unitless per NONMEM reporting.
Measured: 24 hours
Creatinine Count CL
Pharmacokinetic data was analyzed with NONMEM, using both the first-order and conditional non-Laplacian (with centering) estimation techniques. We considered two- and three-compartment models, parameterized in terms of both compartment volumes and clearances (distribution and elimination). We compared a basic model (in which pharmacokinetic parameters were independent of weight) to a model in which the pharmacokinetic parameters were assumed to be proportional to weight. The optimal model was selected on the basis of the objective function logarithm of the likelihood of the results) using standard criteria (NONMEM guide).
Equations from optimal model:
CL=109*((WT/70)0.75) * (SCRint^-0.084) * ((NIRSInt)/96)^ -0.27 ) * ((PLTint)/130)^0.45) V1=1,160*(WT/70) * (TxTot)^0.03) Q=174*((WT/70)0.75) V2=1080 *(WT/70)
"Creatinine Count CL" equals clearance (CL) affected by the covariate of Creatinine levels (SCRint). This value is unitless per NONMEM reporting.
Measured: 24 hours
V2- Peripheral Volume (L/70kg)
Pharmacokinetic data was analyzed with NONMEM, using both the first-order and conditional non-Laplacian (with centering) estimation techniques. We considered two- and three-compartment models, parameterized in terms of both compartment volumes and clearances (distribution and elimination). We compared a basic model (in which pharmacokinetic parameters were independent of weight) to a model in which the pharmacokinetic parameters were assumed to be proportional to weight. The optimal model was selected on the basis of the objective function logarithm of the likelihood of the results) using standard criteria (NONMEM guide).
Equations from optimal model:
CL=109*((WT/70)0.75) * (SCRint^-0.084) * ((NIRSInt)/96)^ -0.27 ) * ((PLTint)/130)^0.45) V1=1,160*(WT/70) * (TxTot)^0.03) Q=174*((WT/70)0.75) V2=1080 *(WT/70)
"V2" equals Peripheral Volume in L/70kg.
Measured: 24 hours
Q- Intercompartmental Clearance (L/70kg)
Pharmacokinetic data was analyzed with NONMEM, using both the first-order and conditional non-Laplacian (with centering) estimation techniques. We considered two- and three-compartment models, parameterized in terms of both compartment volumes and clearances (distribution and elimination). We compared a basic model (in which pharmacokinetic parameters were independent of weight) to a model in which the pharmacokinetic parameters were assumed to be proportional to weight. The optimal model was selected on the basis of the objective function logarithm of the likelihood of the results) using standard criteria (NONMEM guide).
Equations from optimal model:
CL=109*((WT/70)0.75) * (SCRint^-0.084) * ((NIRSInt)/96)^ -0.27 ) * ((PLTint)/130)^0.45) V1=1,160*(WT/70) * (TxTot)^0.03) Q=174*((WT/70)0.75) V2=1080 *(WT/70)
"Q" equals intercompartmental clearance in L/70kg.
Measured: 24 hours
V1- Central Volume (L/70kg)
Pharmacokinetic data was analyzed with NONMEM, using both the first-order and conditional non-Laplacian (with centering) estimation techniques. We considered two- and three-compartment models, parameterized in terms of both compartment volumes and clearances (distribution and elimination). We compared a basic model (in which pharmacokinetic parameters were independent of weight) to a model in which the pharmacokinetic parameters were assumed to be proportional to weight. The optimal model was selected on the basis of the objective function logarithm of the likelihood of the results) using standard criteria (NONMEM guide).
Equations from optimal model:
CL=109*((WT/70)0.75) * (SCRint^-0.084) * ((NIRSInt)/96)^ -0.27 ) * ((PLTint)/130)^0.45) V1=1,160*(WT/70) * (TxTot)^0.03) Q=174*((WT/70)0.75) V2=1080 *(WT/70)
"V1" equals central volume in L/70kg.
Measured: 24 hours
CL- Clearance of TXA (mL/(Min*70kg))
Pharmacokinetic data was analyzed with NONMEM, using both the first-order and conditional non-Laplacian (with centering) estimation techniques. We considered two- and three-compartment models, parameterized in terms of both compartment volumes and clearances (distribution and elimination). We compared a basic model (in which pharmacokinetic parameters were independent of weight) to a model in which the pharmacokinetic parameters were assumed to be proportional to weight. The optimal model was selected on the basis of the objective function logarithm of the likelihood of the results) using standard criteria (NONMEM guide).
Equations from optimal model:
CL=109*((WT/70)0.75) * (SCRint^-0.084) * ((NIRSInt)/96)^ -0.27 ) * ((PLTint)/130)^0.45) V1=1,160*(WT/70) * (TxTot)^0.03) Q=174*((WT/70)0.75) V2=1080 *(WT/70)
"CL" equals clearance of TXA in mL/(min*70kg).
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2015 (estimated)
- Study startFeb 2016
- Primary completion4 Jul 2017
- Study completion7 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HemorrhageStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Philip C Spinella, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02535949
- Sponsor's protocol ID
- TAMPITI TRIAL
- Acronym
- TAMPITI
- Status last verified
- Aug 2021
- First submitted
- 5 Dec 2014
- Last updated
- 31 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Zakar R, Topper GV, Abdullah A, Mollen M, Subhasish T, Younes R, Zenati MS, Thomas KA, Egodage T, Kerlin BA, Bochicchio GV, Mihalko EP, Coleman JR, Spinella PC, Shea SM, Neal MD. Thrombin-Antithrombin Complex and Fibrinogen Predict Microangiopathic Acute Kidney Injury in Injured Patients. Blood Adv. 2026 Sep 1:bloodadvances.2026020806. doi: 10.1182/bloodadvances.2026020806. Online ahead of print.
PubMed 42678921Leonard JM, Ghosh S, Bochicchio GV, Spinella PC, Turnbull IR. Acute Trauma and Critical Illness Cause Increases in G-CSF that Correlate with Post-Injury Outcomes and are Associated with Changes in Bone Marrow Progenitor Populations. Shock. 2026 Sep 1;66(3):638-648. doi: 10.1097/SHK.0000000000002786. Epub 2026 Feb 2.
PubMed 41736410Stitt G, Spinella PC, Bochicchio GV, Roberts I, Downes KJ, Zuppa AF. Population pharmacokinetic modelling and simulation of tranexamic acid in adult trauma patients. Br J Clin Pharmacol. 2024 Aug;90(8):1932-1941. doi: 10.1111/bcp.16075. Epub 2024 May 2.
PubMed 38697615Spinella PC, Thomas KA, Turnbull IR, Fuchs A, Bochicchio K, Schuerer D, Reese S, Coleoglou Centeno AA, Horn CB, Baty J, Shea SM, Meledeo MA, Pusateri AE, Levy JH, Cap AP, Bochicchio GV; TAMPITI Investigators. The Immunologic Effect of Early Intravenous Two and Four Gram Bolus Dosing of Tranexamic Acid Compared to Placebo in Patients With Severe Traumatic Bleeding (TAMPITI): A Randomized, Double-Blind, Placebo-Controlled, Single-Center Trial. Front Immunol. 2020 Sep 8;11:2085. doi: 10.3389/fimmu.2020.02085. eCollection 2020.
PubMed 33013880
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tranexamic Acid Mechanisms and Pharmacokinetics in Traumatic Injury (TAMPITI TRIAL)
- ClinicalTrials.gov ID
- NCT02535949
- Acronym / sponsor ID
- TAMPITI / TAMPITI TRIAL
- Conditions
- Hemorrhage, Shock, Wounds and Injuries
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- Feb 2016
- Primary completion
- 4 Jul 2017 (actual)
- Study completion
- 7 Jul 2017 (actual)
- First posted
- 31 Aug 2015 (estimated)
- Results
- Posted 31 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effects of TXA on the immune system, its pharmacokinetics, as well as safety and efficacy in severely injured trauma patients.
Detailed description
Trauma is the leading cause of death in persons younger than 40 years. Hemorrhage is the etiology in 30% of these deaths, and remains the leading cause of potentially preventable mortality (66-80%) on the battlefield. Death secondary to hemorrhagic shock occurs from both surgical bleeding and coagulopathy. Due to the knowledge of increased fibrinolysis promoting a hypocoagulable state in severe trauma, trials have been performed to determine if antifibrinolytics such as tranexamic acid (TXA) could reduce morbidity and mortality by reducing death from hemorrhage. TXA is an antifibrinolytic that inhibits both plasminogen activation and plasmin activity, thus preventing clot break-down rather than promoting new clot formation. Despite the extensive use of TXA in many surgical populations and an increasing use in severe trauma patients, TXA does not have an FDA approved indication for patients with traumatic injuries. The effect of TXA on immune function has not been thoroughly examined, especially in patients with severe traumatic injury. The study of the effects of TXA use on endothelial activation and injury is also important due to the inter-relationship between coagulation and endothelial function. Endothelial injury secondary to local hypoperfusion causes acute traumatic coagulopathy with fibrinolysis. Therefore a thorough and comprehensive evaluation of the effects of TXA on immune, coagulation, and endothelial parameters is important to allow for a better understanding of the mechanisms of action of this agent.
This is a randomized placebo controlled trial to obtain mechanism of action data, pharmacokinetic information, and efficacy and safety data for the use of TXA in severely injured trauma patients. Participants will be randomized into 1 of 3 treatment arms (1:1:1): TXA 2 gram IV bolus, TXA 4 gram IV bolus, or placebo. The study period is from time of enrollment to hospital discharge or transfer. The study intervention will occur only once upon enrollment in the trial. Participants will receive study drug within two hours from their initial injury. Blood samples will be drawn at multiple time points for immune parameters, Pharmacodynamics, and repository samples.
Immune parameter samples will be drawn at at approximately 0, 6, 24 and 72 hours after study drug/placebo administration.
Pharmacokinetic and pharmacodynamic samples will be drawn according to two schedules. Even number sampling times, blood will be drawn at the approximate time points: 0, 20 min, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, and 12 hr. A patient sampled on odd number sampling times will have samples drawn at the approximate time points: 0, 10 min, 40 min, 1.5 hr, 3 hr, 6 hr, 10 hr and 24 hr.
Repository samples will be drawn at approximate time points: 0, 1, 6, 24, and 72 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tranexamic Acid 2 Gram | Experimental | Drug: Tranexamic AcidOne time dose IV TXA 2 Grams given over 10 minutes within 2 hours of initial injury |
| Tranexamic Acid 4 Gram | Experimental | Drug: Tranexamic AcidOne time dose IV TXA 4 Grams given over 10 minutes within 2 hours of initial injury |
| Placebo | Placebo comparator | Other: PlaceboMatching Volume Normal Saline Placebo given IV over 10 minutes within 2 hours of initial injury |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with traumatic injury that are ordered to receive at least 1 blood product and/or
- Patients admitted to the Emergency Department with a traumatic injury and require immediate transfer to the operating room to control the bleeding
- Able to receive the study drug within 2 hours from estimated time of injury **Please note that in circumstances where the patient initially met inclusion/exclusion criteria (i.e. received blood products in the ED before a full evaluation of their injuries is complete) but is later found to only have a soft tissue involved injury or does not have a traumatic bleeding source), the Investigator may determine that the patient should not be randomized into the trial and the patient should be considered a screen failure
Key exclusion criteria (13 listed)
- Patients known to be < 18 years of age
- Suspected Acute MI or stroke(thromboembolic and/or hemorrhagic) on admission
- Known inherited coagulation disorders
- Known history of thromboembolic events (DVT, PE, MI, Stroke)
- Known history of seizures and/or seizure after injury/on admission related to this hospitalization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic AcidAlso: CyklokapronTranexamic acid is a man-made form of an amino acid (protein) called lysine. Tranexamic acid prevents enzymes in the body from breaking down blood clots. | Drug | Tranexamic Acid 2 Gram, Tranexamic Acid 4 Gram |
| PlaceboMatching Volume Normal Saline Placebo given IV over 10 minutes within 2 hours of initial injury | Other | Placebo |
Primary outcome
Change in HLA-DR Expression on Monocytes 72 Hours After Drug or Placebo Administration in Patient Groups (0g TXA (Placebo); 2g TXA; 4g TXA)."
Time frame: Samples Drawn through 72 hours after study initiation
Blood was drawn from patients at baseline (0 h, just before placebo or drug administration) and at 72 hours post placebo or drug administration. Leukocytes in these blood samples were stained with fluroescent antibodies specific for CD45, CD14, and HLA-DR, analyzed by flow cytometry, and the median fluorescen intensity (MFI) of HLA-DR signal was recorded for monocytes (CD45+CD14+). The fold change in HLA-DR expression from prior to placebo/drug administration to 72 h after placebo/drug administration ("0 h : 72 h") was calculated as HLA-DR MFI72hours ÷ HLA-DR CD14 MFI0hours. Non-paramteric one-way ANOVA (Kruskal-Wallis test) was performed between each treatment group at the given time pont, and the p-value reported.
13 secondary outcomes
Differences in Cytokine Profiles Between the Three Study Groups
Time frame: Samples Drawn through 72 hours after study initiation
Differences in Leukocyte Function Parameters Between the Three Study Groups
Time frame: Samples Drawn through 72 hours after study initiation
Total Transfusion Volume CL
Time frame: 24 hours
Determine the Incidence of Thromboembolic Events (DVT, MI, PE, Stroke) in All Three Study Groups.
Time frame: Hospital Discharge (average 10 days)
Determine the Incidence of Seizures at 24 Hours in All Three Study Groups.
Time frame: 24 hours following TXA
Determine the Incidence of All Adverse Events in All Three Study Groups
Time frame: Hospital Discharge (average 10 days)
Platelet Count CL
Time frame: 24 hours
Near Infrared Spectroscopy CL
Time frame: 24 hours
Creatinine Count CL
Time frame: 24 hours
V2- Peripheral Volume (L/70kg)
Time frame: 24 hours
Q- Intercompartmental Clearance (L/70kg)
Time frame: 24 hours
V1- Central Volume (L/70kg)
Time frame: 24 hours
CL- Clearance of TXA (mL/(Min*70kg))
Time frame: 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42678921Zakar R, Topper GV, Abdullah A, Mollen M, Subhasish T, Younes R, Zenati MS, Thomas KA, Egodage T, Kerlin BA, Bochicchio GV, Mihalko EP, Coleman JR, Spinella PC, Shea SM, Neal MD. Thrombin-Antithrombin Complex and Fibrinogen Predict Microangiopathic Acute Kidney Injury in Injured Patients. Blood Adv. 2026 Sep 1:bloodadvances.2026020806. doi: 10.1182/bloodadvances.2026020806. Online ahead of print.
- Derived from this study: PubMed 41736410Leonard JM, Ghosh S, Bochicchio GV, Spinella PC, Turnbull IR. Acute Trauma and Critical Illness Cause Increases in G-CSF that Correlate with Post-Injury Outcomes and are Associated with Changes in Bone Marrow Progenitor Populations. Shock. 2026 Sep 1;66(3):638-648. doi: 10.1097/SHK.0000000000002786. Epub 2026 Feb 2.
- Derived from this study: PubMed 38697615Stitt G, Spinella PC, Bochicchio GV, Roberts I, Downes KJ, Zuppa AF. Population pharmacokinetic modelling and simulation of tranexamic acid in adult trauma patients. Br J Clin Pharmacol. 2024 Aug;90(8):1932-1941. doi: 10.1111/bcp.16075. Epub 2024 May 2.
- Derived from this study: PubMed 33013880Spinella PC, Thomas KA, Turnbull IR, Fuchs A, Bochicchio K, Schuerer D, Reese S, Coleoglou Centeno AA, Horn CB, Baty J, Shea SM, Meledeo MA, Pusateri AE, Levy JH, Cap AP, Bochicchio GV; TAMPITI Investigators. The Immunologic Effect of Early Intravenous Two and Four Gram Bolus Dosing of Tranexamic Acid Compared to Placebo in Patients With Severe Traumatic Bleeding (TAMPITI): A Randomized, Double-Blind, Placebo-Controlled, Single-Center Trial. Front Immunol. 2020 Sep 8;11:2085. doi: 10.3389/fimmu.2020.02085. eCollection 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip C Spinella, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tranexamic Acid in people with Hemorrhage and Shock, run by Washington University School of Medicine at 1 site in United States.
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 3 inclusion and 13 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 31 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 31 Aug 2021). 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?
Change in HLA-DR Expression on Monocytes 72 Hours After Drug or Placebo Administration in Patient Groups (0g TXA (Placebo); 2g TXA; 4g TXA)." (time frame: Samples Drawn through 72 hours after study initiation). 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 NCT02535949, which also lists 4 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 31 Aug 2021.