Study of Local Administration of DepoTXA for Reduced Postsurgical Bleeding in Subjects Undergoing TKA
NCT ID: NCT02922582
Last Updated: 2020-12-11
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
16 participants
INTERVENTIONAL
2016-10-28
2017-11-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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DepoTXA 400mg
400mg Intracapsular at the end of surgery one time
DepoTXA
DepoTXA 800mg
800mg Intracapsular at the end of surgery one time
DepoTXA
DepoTXA 1200mg
1200mg Intracapsular at the end of surgery one time
DepoTXA
IV Tranexamic acid (TXA)
1 g of IV TXA at the end of surgery
Tranexamic Acid
Interventions
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DepoTXA
Tranexamic Acid
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Pacira Pharmaceuticals, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Hassan Danesi, MD
Role: STUDY_DIRECTOR
Pacira Pharmaceuticals, Inc
Locations
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Ortho Arizona
Gilbert, Arizona, United States
University of Miami Hospital
Miami, Florida, United States
Kendall Regional Medical Center
Miami, Florida, United States
Ohio State University/Wexner Medical Center
Columbus, Ohio, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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404-C-201
Identifier Type: -
Identifier Source: org_study_id