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Tranexamic Acid · 2 trials · 5 indications
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.
| Arm | Type | Description |
|---|---|---|
| Tranexamic Acid 2 Gram | EXPERIMENTAL | One time dose IV TXA 2 Grams given over 10 minutes within 2 hours of initial injury |
| Tranexamic Acid 4 Gram | EXPERIMENTAL | One time dose IV TXA 4 Grams given over 10 minutes within 2 hours of initial injury |
| Placebo | PLACEBO_COMPARATOR | Matching Volume Normal Saline Placebo given IV over 10 minutes within 2 hours of initial injury |
| Intervention | ACTIVE_COMPARATOR | Subjects will receive tranexamic acid on the surgical wound. |
| Placebo control | PLACEBO_COMPARATOR | Subjects will receive placebo (saline solution) on the surgical wound. |
| Name | Type | Description |
|---|---|---|
| Tranexamic Acid | DRUG | 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. |
| Placebo | OTHER | Matching Volume Normal Saline Placebo given IV over 10 minutes within 2 hours of initial injury |
Inclusion Criteria: 1. Patients with traumatic injury that are ordered to receive at least 1 blood product and/or 2. Patients admitted to the Emergency Department with a traumatic injury and require immediate transfer to the operating room to control the bleeding 3. Able to receive the study drug w...
Tranexamic Acid is a small molecule being developed by United Therapeutics Corporation for use in spinal injuries and hemorrhage. It is currently in Phase 2 clinical trials to reduce blood loss in spine surgery and to study its mechanisms and pharmacokinetics in traumatic injury.
Tranexamic Acid is an antifibrinolytic agent that works by inhibiting the breakdown of blood clots. It does not target a specific molecular receptor but rather acts on the fibrinolytic system to stabilize clots and reduce bleeding.
Tranexamic Acid is being developed by United Therapeutics Corporation, a publicly traded company listed on NASDAQ under the ticker symbol UTHR. The company is conducting Phase 2 clinical trials for this drug in the United States.
Tranexamic Acid is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA for the indications being studied. Two Phase 2 trials are listed: one recruiting and one completed.
Tranexamic Acid is being studied in two Phase 2 trials. NCT02314988 is a randomized, double-blind, placebo-controlled trial with 252 participants to reduce blood loss in spine surgery. NCT02535949 is a completed trial with 150 participants studying its mechanisms in traumatic injury.
Tranexamic Acid is commonly known by the abbreviation TXA, though this alternative name is not provided in the available data. The drug is being investigated under the name Tranexamic Acid in clinical trials for spinal injuries and hemorrhage.