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Topical Tranexamic Acid (TXA) in Joint Arthroplasty

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ClinicalTrials.gov Identifier: NCT01937559
Recruitment Status : Recruiting
First Posted : September 9, 2013
Last Update Posted : April 8, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The objective of this study is to evaluate the efficacy of topical tranexamic acid (TXA) in decreasing blood loss following both shoulder arthroplasty and primary total hip arthroplasty. TXA functions to decrease blood loss by affecting the blood clotting system within the body. The investigators hypothesize that topical application of TXA prior to closure reduces postoperative bleeding as measured by absolute changes in postoperative hemoglobin levels and surgical drain output. In addition, use of topically applied tranexaminic acid may reduce the need for transfusions, the rates of hematomas, infections, and length of hospital stay.

Condition or disease Intervention/treatment Phase
Osteoarthritis Hip Arthropathy Shoulder Arthropathy Biological: Tranexaminic Acid (TXA) Drug: Normal saline Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Topical Application of Tranexamic Acid in Joint Arthroplasty
Study Start Date : April 2013
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Antifibrinolytic agent
Tranexaminic acid (TXA)
Biological: Tranexaminic Acid (TXA)
1.5g of TXA in 100ml normal saline solution
Other Name: Cyklokapron
Placebo Comparator: Saline
Normal saline
Drug: Normal saline


Outcome Measures

Primary Outcome Measures :
  1. Post-operative blood loss [ Time Frame: Duration of hospital stay ]
    Blood loss will be calculated as the difference between the preoperative hemoglobin and the lowest postoperative hemoglobin during the hospital stay or the lowest postoperative hemoglobin prior to blood transfusion.


Secondary Outcome Measures :
  1. Perioperative blood transfusions [ Time Frame: Duration of surgery ]
  2. Number of blood units transfused [ Time Frame: Duration of surgery ]
  3. Rate of surgical infections [ Time Frame: Duration of hospital stay ]
  4. Length of hospital stay [ Time Frame: Duration of hospital stay ]
  5. Time until start of rehabilitation program [ Time Frame: Up to 3 weeks post-surgery ]
  6. Postoperative changes in joint function [ Time Frame: Duration of hospital stay ]
    Increase or reduction in ROM of the knee will be accounted for during the patient's stay at the hospital post-surgery.


Other Outcome Measures:
  1. Shoulder outcome scores [ Time Frame: 6 months post-surgery ]
    Shoulder outcome scores will include a PENN derived ASES form.

  2. General outcome scores [ Time Frame: 6 months post-surgery ]
    General outcome measures will include EQ-5D, GROC and SANE forms.

  3. Hip outcome scores [ Time Frame: 6 months ]
    Hip outcome measurements will include Harris Hip score and the WOMAC forms.


Eligibility Criteria

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

Inclusion Criteria:

  • Shoulders: All adult patients over the age of 18 scheduled for a primary total arthroplasty or a primary reverse shoulder arthroplasty will be eligible for inclusion in the study.

Hips: All adult patients over the age of 18 scheduled for a primary total hip arthroplasty will be eligible for inclusion in the study.

Exclusion Criteria:

  • allergy to TXA, refusal of blood products, preoperative use of anticoagulant therapy within 5 days of surgery, history of seizures, renal failure (creatine clearance <30ml/min), bleeding disorders, venous thromboembolism (deep vein thrombosis and/or pulmonary embolism), significant cardiac history (myocardial infarction, angina, stroke, lower limb ischemia), or perioperative anemia (hemoglobin <11g/dl in females and < 12g/dl in males).
Contacts and Locations

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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): NCT01937559


Contacts
Contact: Carlisle Shealy, BS 864-454-7458 carlisle.shealy@hawkinsfoundation.com

Locations
United States, South Carolina
Steadman Hawkins Clinic of the Carolinas - Greenville Health System Recruiting
Greenville, South Carolina, United States, 29615
Contact: Carlisle Shealy, MD    864-454-7458    carlisle.shealy@hawkinsfoundation.com   
Principal Investigator: Brian Burnikel, MD         
Sub-Investigator: Richard J Hawkins, MD         
Sub-Investigator: Michael J Kissenberth, MD         
Sub-Investigator: Stefan Tolan, MD         
Sub-Investigator: Brayton R Shirley, MD         
Sub-Investigator: Phillip H Wessinger, MD         
Sponsors and Collaborators
The Hawkins Foundation
Investigators
Principal Investigator: Brian Burnikel, MD Steadman Hawkins Clinic of the Carolinas - Greenville Health System
More Information

Responsible Party: The Hawkins Foundation
ClinicalTrials.gov Identifier: NCT01937559     History of Changes
Other Study ID Numbers: Pro00021253
First Posted: September 9, 2013    Key Record Dates
Last Update Posted: April 8, 2016
Last Verified: April 2016

Keywords provided by The Hawkins Foundation:
tranexaminic acid (TXA)

Additional relevant MeSH terms:
Osteoarthritis
Joint Diseases
Arthritis
Musculoskeletal Diseases
Rheumatic Diseases
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants