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Reducing Hemarthrosis in Tibial Tubercle Osteotomy by the Administration of Intravenous Tranexamic Acid

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ClinicalTrials.gov Identifier: NCT03606109
Recruitment Status : Recruiting
First Posted : July 30, 2018
Last Update Posted : August 21, 2020
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Brief Summary:
The purpose of the proposed study is to evaluate the effects of administering intravenous tranexamic acid (TXA) to patients undergoing tibial tubercle osteotomy (TTO) to minimize hemarthrosis within the knee joint and post-operative pain.

Condition or disease Intervention/treatment Phase
Tibial Tubercle Osteotomy Drug: Tranexamic Acid (TXA) Phase 4

Detailed Description:
Not Provided

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Reducing Hemarthrosis in Tibial Tubercle Osteotomy by the Administration of Intravenous Tranexamic Acid
Actual Study Start Date : June 26, 2018
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: TTO + IV TXA Drug: Tranexamic Acid (TXA)
Patients will be given 1 gram of intravenous tranexamic acid (TXA) before tourniquet inflation and 1 gram of IV TXA before closure of the incision.

No Intervention: TTO, no IV TXA



Primary Outcome Measures :
  1. Post-operative hemarthrosis [ Time Frame: Day 1 ]
    measured by documenting peri-operative blood loss and assessing the operative knee at the first post-operative visit


Secondary Outcome Measures :
  1. Post-operative opioid consumption [ Time Frame: Day 1 ]
  2. Post-operative opioid consumption [ Time Frame: Day 4 ]
  3. Post-operative opioid consumption [ Time Frame: Day 7 ]
  4. Post-operative patient reported pain score on the visual analog scale [ Time Frame: Day 1 ]
    The visual analog scale (VAS) is a validated, subjective measure for pain. Scores range from 0-10 (0 = no pain, 10 = worst pain). The higher the score, the worse the pain.

  5. Post-operative patient reported pain score on the visual analog scale [ Time Frame: Day 4 ]
    The visual analog scale (VAS) is a validated, subjective measure for pain. Scores range from 0-10 (0 = no pain, 10 = worst pain). The higher the score, the worse the pain.

  6. Post-operative patient reported pain score on the visual analog scale [ Time Frame: Day 7 ]
    The visual analog scale (VAS) is a validated, subjective measure for pain. Scores range from 0-10 (0 = no pain, 10 = worst pain). The higher the score, the worse the pain.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing TTO
  • Age 18-60
  • Willing and able to provide consent

Exclusion Criteria:

  • Legally incompetent or mentally impaired (e.g., minors, Alzheimer's subjects, dementia, etc.)
  • Younger than 18 years of age
  • Older than 60 years of age
  • Any patient considered a vulnerable subject
  • Have bleeding or clotting disorder
  • Preoperative anticoagulation therapy
  • Abnormal coagulation profile
  • Renal disorder or insufficiency
  • Sickle cell disease

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): NCT03606109


Contacts
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Contact: Anna Blaeser 6513238241 Anna.Blaeser@nyulangone.org

Locations
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United States, New York
New York University School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Anna Blaeser    651-323-8241    Anna.Blaeser@nyulangone.org   
Principal Investigator: Michael Alaia, MD         
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Michael Alaia, MD NYU Langone Health
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03606109    
Other Study ID Numbers: 18-00535
First Posted: July 30, 2018    Key Record Dates
Last Update Posted: August 21, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NYU Langone Health:
Tibial Tubercle Osteotomy
Tranexamic Acid
Additional relevant MeSH terms:
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Hemarthrosis
Joint Diseases
Musculoskeletal Diseases
Hemorrhage
Pathologic Processes
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants