Trial · NCT02535949
Outcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| 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 |
| SECONDARY | V2- Peripheral Volume (L/70kg) | 24 hours | Of the 99 participants analyzed 49 received the 2 gram dose and 50 received the 4 gram dose. | L/70kg | MEAN |
| SECONDARY | Q- Intercompartmental Clearance (L/70kg) | 24 hours | Of the 99 participants analyzed, 49 received the 2 gram dose and 50 received the 4 gram dose. | L/70kg | MEAN |
| SECONDARY | V1- Central Volume (L/70kg) | 24 hours | Of the 99 participants analyzed, 49 received the 2 gram dose and 50 received the 4 gram dose. | L/70kg | MEAN |
| SECONDARY | CL- Clearance of TXA (mL/(Min*70kg)) | 24 hours | Of the 99 participants analyzed, 49 received the 2 gram dose and 50 received the 4 gram dose. | mL/(min*70kg) | MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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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