Study of Local Administration of DepoTXA for Reduced Postsurgical Bleeding in Subjects Undergoing TKA
Condition: Total Knee Arthroplasty
MeSH terms: Hemorrhage
Intervention: DepoTXA; Tranexamic Acid
Intervention MeSH terms: Tranexamic Acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a Phase 2, randomized, single-blind, active-controlled dose-ranging study in subjects
      scheduled to undergo total knee arthroplasty (TKA).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female, ≥18 years of age at screening.

          2. Scheduled to undergo elective unilateral open TKA under general, spinal, or regional
             anesthesia.

          3. American Society of Anesthesiology (ASA) physical status 1, 2, or 3.

          4. Female subject must be surgically sterile; or at least 2 years postmenopausal; or have
             a monogamous partner who is surgically sterile; or practicing double-barrier
             contraception; or practicing abstinence (must agree to use double-barrier
             contraception in the event of sexual activity); or using an insertable, injectable, or
             transdermal, contraceptive approved by the FDA for greater than 2 months prior to
             screening and commit to the use of an acceptable form of birth control for the
             duration of the study and for 30 days after completion of the study.

          5. Able to provide informed consent, adhere to the study visit schedule, and complete all
             study assessments.

        Exclusion Criteria:

          1. Currently pregnant, nursing, or planning to become pregnant during the study or within
             1 month after study drug administration.

          2. Planned concurrent surgical procedure (e.g., bilateral TKA).

          3. Prior open knee surgery on ipsilateral knee. Prior arthroscopy is permitted.

          4. Subjects taking a medication with a known procoagulant effect (e.g., combination
             hormonal contraceptives, Factor IX complex concentrates or anti-inhibitor coagulant
             concentrates, or all-trans retinoic acid).

          5. Contraindication or hypersensitivity to TXA.

          6. History of thrombosis or prior Venous thromboembolism (VTE).

          7. Known coagulopathy or active intravascular clotting.

          8. Prior myocardial infarction.

          9. Prior cardiovascular accident (stroke) or subarachnoid hemorrhage.

         10. History of epilepsy.

         11. Presence of an intravascular stent.

         12. History of impaired kidney function, chronic respiratory disease, rheumatoid
             arthritis, coagulopathy, or loss of sensation in extremities.

         13. Renal insufficiency (serum creatinine level >2 mg/dL).

         14. Anemia (Hb level <10 g/dL).

         15. Uncontrolled anxiety, psychiatric, or neurological disorder that might interfere with
             study assessments.

         16. Acquired defective color vision.

         17. Malignancy in the last 2 years, with the exception of non-metastatic basal cell or
             squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix.

         18. Suspected or known history of drug or alcohol abuse within the previous year.

         19. Body weight <50 kg (110 pounds) or a body mass index >44 kg/m2.

         20. Administration of an investigational drug within 30 days or 5 elimination half-lives
             of such investigational drug, whichever is longer, prior to study drug administration,
             or planned administration of another investigational product or procedure during the
             subject's participation in this study.