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Study of Local Administration of DepoTXA for Reduced Bleeding in Subjects Undergoing TKA

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02922582
Recruitment Status : Terminated (Slow Enrollment)
First Posted : October 4, 2016
Last Update Posted : December 13, 2017
Sponsor:
Information provided by (Responsible Party):
Pacira Pharmaceuticals, Inc

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

Condition or disease Intervention/treatment Phase
Total Knee Arthroplasty Drug: DepoTXA Drug: Tranexamic Acid Phase 2

Detailed Description:
Approximately 45 subjects (15 per arm) are planned for enrollment. Subjects will be randomized in a 1:1:1 ratio to receive either DepoTXA 800 mg, DepoTXA 1200 mg, or IV TXA (Cyklokapron® 1 gram).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Randomized, Single-Blind, Active-Controlled, Dose-Ranging Study To Evaluate PK, Safety, and Efficacy of Local Administration of DepoTXA for Reduced Post-Surgical Bleeding in Subjects Undergoing TKA
Actual Study Start Date : October 28, 2016
Actual Primary Completion Date : November 16, 2017
Actual Study Completion Date : November 16, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: IV Tranexamic acid (TXA)
1 gram IV TXA intraoperatively at the end of surgery one time
Drug: Tranexamic Acid
Experimental: DepoTXA 800mg
800mg Intracapsular at the end of surgery one time
Drug: DepoTXA
Experimental: DepoTXA 1200mg
1200mg Intracapsular at the end of surgery one time
Drug: DepoTXA



Primary Outcome Measures :
  1. Total postsurgical opioid consumption in morphine equivalents [ Time Frame: through 48 hours ]

Secondary Outcome Measures :
  1. Time to first opioid rescue from PACU discharge [ Time Frame: through 7 days ]
  2. Percentage of opioid-free subjects [ Time Frame: through 48 hours ]
  3. VAS pain intensity scores [ Time Frame: from 0 to 48 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Scheduled to undergo elective unilateral open TKA under general, spinal, or regional anesthesia.
  2. American Society of Anesthesiology (ASA) physical status 1, 2, or 3.
  3. Currently receiving anticoagulation or antiplatelet therapy for cardiovascular disease or thromboembolic risk.
  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. Patients taking a medication with a known procoagulant effect (eg, combination hormonal contraceptives, Factor IX complex concentrates or anti-inhibitor coagulant concentrates, or all-trans retinoic acid).
  5. Contraindication or hypersensitivity to TXA.
  6. Known active intravascular clotting.
  7. Prior subarachnoid hemorrhage.
  8. History of epilepsy.
  9. History of impaired kidney function, chronic respiratory disease, rheumatoid arthritis, congenital coagulopathy, or loss of sensation in extremities.
  10. Renal insufficiency as indicated by serum creatinine > upper limit of normal (by central laboratory assessment).
  11. Anemia (Hb level,10 g/dL)
  12. Uncontrolled anxiety, psychiatric, or neurological disorder that might interfere with study assessments.
  13. Acquired defective color vision.
  14. 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
  15. Suspected or known history of drug or alcohol abuse within the previous year.
  16. Body weight ,50 kg (110 pounds) or a body mass index .44 kg/m2.
  17. 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 patient's participation in this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02922582


Locations
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United States, Arizona
Ortho Arizona
Gilbert, Arizona, United States, 85296
United States, Florida
University of Miami Hospital
Miami, Florida, United States, 33136
Kendall Regional Medical Center
Miami, Florida, United States, 33175
United States, Ohio
Ohio State University/Wexner Medical Center
Columbus, Ohio, United States, 43210
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Pacira Pharmaceuticals, Inc
Investigators
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Study Director: Hassan Danesi, MD Pacira Pharmaceuticals

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Responsible Party: Pacira Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT02922582    
Other Study ID Numbers: 404-C-201
First Posted: October 4, 2016    Key Record Dates
Last Update Posted: December 13, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants