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Oral Versus IV TXA

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: NCT04089865
Recruitment Status : Suspended (response to COVID-19)
First Posted : September 13, 2019
Last Update Posted : April 22, 2020
Sponsor:
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

Brief Summary:

Tranexamic acid (TXA) is an antifibrinolytic medication used to reduce bleeding in a variety of medical settings. The use of TXA in total hip arthroplasty (THA) and total knee arthroplasty (TKA) has resulted in dramatic decreases in operative blood loss and transfusion rates, revolutionizing the field of arthroplasty. The use of TXA, now common, has made autologous blood donation programs largely obsolete. Additionally, it has made perioperative blood transfusion uncommon.

While AAOS guidelines suggest that all three available preparations of TXA (oral, IV, topical) are effective, preferred route of dosing varies by provider and institution. These preferences are based on habit, understanding of pharmacodynamics, and logistical issues regarding effective dosing. Oral TXA is the cheapest option, but some surgeons prefer IV dosing due to concerns regarding efficacy and controlled dosing.

In this study, we seek to compare the efficacy of a single pre-op oral dose of TXA to a single pre-op IV dose of TXA.


Condition or disease Intervention/treatment Phase
Blood Loss Blood Transfusion Drug: Tranexamic Acid Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Blood Loss in Arthroplasty With Oral Versus IV Tranexamic Acid
Actual Study Start Date : June 4, 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Oral Tranexamic Acid (TXA)
100 Total Hip Arthroplasty (THA) and 100 Total Knee Arthroplasty (TKA) patients will be randomized to receive 1950 mg of oral TXA in the pre-operative area.
Drug: Tranexamic Acid
Tranexamic acid (TXA) is an antifibrinolytic medication used to reduce bleeding in a variety of medical settings. Patients will be randomized to receive either oral or intravenous tranexamic acid.

Active Comparator: Intravenous (IV) Tranexamic Acid (TXA)
100 Total Hip Arthroplasty (THA) and 100 Total Knee Arthroplasty (TKA) patients will be randomized to receive 1 g of intravenous (IV) TXA upon transfer to the operating room.
Drug: Tranexamic Acid
Tranexamic acid (TXA) is an antifibrinolytic medication used to reduce bleeding in a variety of medical settings. Patients will be randomized to receive either oral or intravenous tranexamic acid.




Primary Outcome Measures :
  1. Calculated Blood Loss [ Time Frame: Post-Operative Day 0, 1 ]
    Calculated blood loss (CBL) in cc, to be calculated according to Gao (PMID 26521781)


Secondary Outcome Measures :
  1. Transfusion during hospital stay [ Time Frame: During length of hospital stay (estimated Post-Operative Day 1, 2) ]
    Both binary yes/no and discrete volume transfused

  2. Time to discharge from physical therapy [ Time Frame: During length of hospital stay (estimated 48-72 hours after surgery) ]
    Time to discharge from physical therapy (in hours)

  3. Length of Stay [ Time Frame: During length of hospital stay (estimated 48-72 hours after surgery) ]
    Hospital length of stay (in hours)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients undergoing total hip arthroplasty (THA) through a posterior approach
  • Patients undergoing total knee arthroplasty (TKA)
  • Patients between 18-80 years of age

Exclusion Criteria:

  • Patients with >80 years of age
  • Patients with a BMI over 40
  • Patients undergoing general anesthesia
  • Patients with a history of major ipsilateral joint surgery
  • Patients on pre-operative anticoagulation or anti-platelet drugs (other than aspirin)
  • Patients with a history of bleeding disorders
  • Patients with platelets less than 100/nl
  • Patients with new-onset/active atrial fibrillation
  • Patients with a history of myocardial infarction in the past year
  • Patients with a history of a stroke in the past year

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): NCT04089865


Locations
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United States, New York
Hospital for Special Surgery
New York, New York, United States, 10021
Sponsors and Collaborators
Hospital for Special Surgery, New York
Investigators
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Principal Investigator: Stavros Memtsoudis, MD PhD Hospital for Special Surgery, New York
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Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT04089865    
Other Study ID Numbers: 2019-0882
First Posted: September 13, 2019    Key Record Dates
Last Update Posted: April 22, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Certain individual participant data will be available. Individual participant data that underlie the results reported in a future article, after deidentification (text, tables, figures, appendices).
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Analytic Code
Time Frame: Beginning 3 months and ending 5 years following article publication.
Access Criteria: Researchers who provide a methodologically sound proposal, in order to achieve aims in the approved proposal.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
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