Trial · NCT02535949
Tranexamic Acid Mechanisms and Pharmacokinetics in Traumatic Injury
NCT02535949, Phase 2, Completed, Washington University School of Medicine; results first posted 2021-08-31
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Tranexamic Acid Mechanisms and Pharmacokinetics in Traumatic Injury. Trials, record NCT02535949. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02535949
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Tranexamic Acid Mechanisms and Pharmacokinetics in Traumatic Injury
- NCT number
- NCT02535949
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 150 participants, actual
- Lead sponsor
- Washington University School of Medicine
- Conditions
- Hemorrhage, Shock, Wounds and Injuries
- Interventions
- Tranexamic Acid, Placebo
- First posted
- 2015-08-31
- Last updated
- 2021-08-31
- Results first posted
- 2021-08-31
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in HLA-DR Expression on Monocytes 72 Hours After Drug or Placebo Administration in Patient Groups (0g TXA (Placebo); 2g TXA; 4g TXA)." | 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. |
| Secondary | Differences in Cytokine Profiles Between the Three Study Groups | Samples Drawn through 72 hours after study initiation | 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: a. Cytokines measured from time 0 to 72 hours. |
| Secondary | Differences in Leukocyte Function Parameters Between the Three Study Groups | Samples Drawn through 72 hours after study initiation | 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: a. Flow cytometric analyses on leukocytes measured from time 0 to 72 hours. |
| Secondary | Total Transfusion Volume CL | 24 hours | 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. |
| Secondary | Determine the Incidence of Thromboembolic Events (DVT, MI, PE, Stroke) in All Three Study Groups. | Hospital Discharge (average 10 days) | The number of events per group for the incidence of thromboembolic events (DVT, MI, PE, Stroke) in all three study groups. |
| Secondary | Determine the Incidence of Seizures at 24 Hours in All Three Study Groups. | 24 hours following TXA | The incidence of seizures at 24 hours in all three study groups. Number of participants with seizures are reported |
| Secondary | Determine the Incidence of All Adverse Events in All Three Study Groups | Hospital Discharge (average 10 days) | All adverse events were totaled for each of the three study groups based on the number of incidents. |
| Secondary | Platelet Count CL | 24 hours | 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. |
| Secondary | Near Infrared Spectroscopy CL | 24 hours | 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. |
| Secondary | Creatinine Count CL | 24 hours | 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. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in HLA-DR Expression on Monocytes 72 Hours After Drug or Placebo Administration in Patient Groups (0g TXA (Placebo); 2g TXA; 4g TXA). | Samples Drawn through 72 hours after study initiation | Change in HLA-DR Expression on Monocytes 72 hours after administration. Leukocytes stained with antibodies and analyzed by flow cytometry. The median fluorescen intensity of HLA-DR signal was measured for monocytes at 0 and 72 hours. Non-paramteric one-way ANOVA was performed and the p-value reported. | fold change | MEDIAN |
| SECONDARY | Differences in Cytokine Profiles Between the Three Study Groups | Samples Drawn through 72 hours after study initiation | Cytokine Levels at 0 and 72 hours after drug or placebo administration in patient groups. Blood was drawn, serum isolated, and frozen. Frozen sera were thawed and the listed cytokines measured uisng a multiplexed platform. Non-paramteric one-way ANOVA was performed between each treatment group, and the p- value reported. | pg/mL | MEDIAN |
| SECONDARY | Differences in Leukocyte Function Parameters Between the Three Study Groups | Samples Drawn through 72 hours after study initiation | Change in CD11b and CD16 Expression on neutrophils 72 hours after. Leukocytes stained with antibodies specific and analyzed by flow cytometry. The median fluorescen intensity of CD11b or CD16 signal was measured on neutrophils. The fold change was measured, MFI72hours/MFI0hours. Non-paramteric one-way ANOVA was performed and the p-value reported. | Fold Change | MEDIAN |
| SECONDARY | Total Transfusion Volume CL | 24 hours | Of the 99 participants analyzed, 49 received the 2 gram dose and 50 received the 4 gram dose. | unitless | MEAN |
| SECONDARY | Determine the Incidence of Thromboembolic Events (DVT, MI, PE, Stroke) in All Three Study Groups. | Hospital Discharge (average 10 days) | The incidence of thromboembolic events (DVT, MI, PE, Stroke) in all three study groups are given based on events per group. | events | NUMBER |
| SECONDARY | Determine the Incidence of Seizures at 24 Hours in All Three Study Groups. | 24 hours following TXA | The incidence of seizures at 24 hours in all three study groups. This was done by totaling the number of participants with reported seizures. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Determine the Incidence of All Adverse Events in All Three Study Groups | Hospital Discharge (average 10 days) | The number of incidents were totaled for the three study groups. | events | NUMBER |
| SECONDARY | Platelet Count CL | 24 hours | Of the 99 participants analyzed, 49 received the 2 gram dose and 50 received the 4 gram dose. | unitless | MEAN |
| SECONDARY | Near Infrared Spectroscopy CL | 24 hours | Of the 99 participants analyzed, 49 received the 2 gram dose and 50 received the 4 gram dose. | unitless | MEAN |
| SECONDARY | Creatinine Count CL | 24 hours | Of the 99 participants analyzed, 49 received the 2 gram dose and 50 received the 4 gram dose. | unitless | MEAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group152
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in HLA-DR Expression on Monocytes 72 Hours After Drug or Placebo Administration in Patient Groups (0g TXA (Placebo); 2g TXA; 4g TXA). | Tranexamic Acid 2 Gram | 0.503 | Inter-Quartile Range 0 to 0.717 | fold change | |
| Change in HLA-DR Expression on Monocytes 72 Hours After Drug or Placebo Administration in Patient Groups (0g TXA (Placebo); 2g TXA; 4g TXA). | Tranexamic Acid 4 Gram | 0.509 | Inter-Quartile Range 0.336 to 0.733 | fold change | |
| Change in HLA-DR Expression on Monocytes 72 Hours After Drug or Placebo Administration in Patient Groups (0g TXA (Placebo); 2g TXA; 4g TXA). | Placebo | 0.532 | Inter-Quartile Range 0.371 to 0.736 | fold change | |
| Differences in Cytokine Profiles Between the Three Study Groups | Tranexamic Acid 2 Gram | ITAC hour 0 | 34.24 | Inter-Quartile Range 25.02 to 55.19 | pg/mL |
| Differences in Cytokine Profiles Between the Three Study Groups | Tranexamic Acid 4 Gram | ITAC hour 0 | 32.75 | Inter-Quartile Range 21.34 to 49.41 | pg/mL |
| Differences in Cytokine Profiles Between the Three Study Groups | Placebo | ITAC hour 0 | 29.34 | Inter-Quartile Range 17.92 to 44.44 | pg/mL |
| Differences in Cytokine Profiles Between the Three Study Groups | Tranexamic Acid 2 Gram | ITAC hour 72 | 25.67 | Inter-Quartile Range 20.76 to 41.14 | pg/mL |
| Differences in Cytokine Profiles Between the Three Study Groups | Tranexamic Acid 4 Gram | ITAC hour 72 | 21.69 | Inter-Quartile Range 13.98 to 34.58 | pg/mL |
| Differences in Cytokine Profiles Between the Three Study Groups | Placebo | ITAC hour 72 | 21.58 | Inter-Quartile Range 13.8 to 33.24 | pg/mL |
| Differences in Cytokine Profiles Between the Three Study Groups | Tranexamic Acid 2 Gram | GM-CSF hour 0 | 67.79 | Inter-Quartile Range 46.73 to 111.19 | pg/mL |
1 to 10 of 152Source ClinicalTrials.gov
See all 152 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tranexamic Acid 2 Gram | 50 | |
| Overall Study | STARTED | Tranexamic Acid 4 Gram | 50 | |
| Overall Study | STARTED | Placebo | 50 | |
| Overall Study | COMPLETED | Tranexamic Acid 2 Gram | 49 | |
| Overall Study | COMPLETED | Tranexamic Acid 4 Gram | 50 | |
| Overall Study | COMPLETED | Placebo | 50 | |
| Overall Study | NOT COMPLETED | Tranexamic Acid 2 Gram | 1 | |
| Overall Study | NOT COMPLETED | Tranexamic Acid 4 Gram | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events48
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Pain | Injury, poisoning and procedural complications | Tranexamic Acid 2 Gram | 0 | 49 | |
| other | Pain | Injury, poisoning and procedural complications | Tranexamic Acid 4 Gram | 0 | 50 | |
| other | Pain | Injury, poisoning and procedural complications | Placebo | 2 | 50 | |
| other | Nausea | Gastrointestinal disorders | Tranexamic Acid 2 Gram | 6 | 49 | |
| other | Nausea | Gastrointestinal disorders | Tranexamic Acid 4 Gram | 16 | 50 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 6 | 50 | |
| other | Sepsis | Infections and infestations | Tranexamic Acid 2 Gram | 6 | 49 | |
| other | Sepsis | Infections and infestations | Tranexamic Acid 4 Gram | 6 | 50 | |
| other | Sepsis | Infections and infestations | Placebo | 2 | 50 | |
| other | Hypotension | Cardiac disorders | Tranexamic Acid 2 Gram | 4 | 49 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tranexamic Acid 2 Gram | 5 | 49 |
| Total, all-cause mortality | Tranexamic Acid 4 Gram | 4 | 50 |
| Total, all-cause mortality | Placebo | 9 | 50 |
| Total, other adverse events | Tranexamic Acid 2 Gram | 25 | 49 |
| Total, other adverse events | Tranexamic Acid 4 Gram | 39 | 50 |
| Total, other adverse events | Placebo | 26 | 50 |
| Total, serious adverse events | Tranexamic Acid 2 Gram | 14 | 49 |
| Total, serious adverse events | Tranexamic Acid 4 Gram | 18 | 50 |
| Total, serious adverse events | Placebo | 13 | 50 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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