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Topical Tranexamic Acid (TXA) in Joint Arthroplasty

This study is currently recruiting participants.
Verified April 2016 by The Hawkins Foundation
Sponsor:
ClinicalTrials.gov Identifier:
NCT01937559
First Posted: September 9, 2013
Last Update Posted: April 8, 2016
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
The Hawkins Foundation
August 30, 2013
September 9, 2013
April 8, 2016
April 2013
September 2016   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01937559 on ClinicalTrials.gov Archive Site
  • Perioperative blood transfusions [ Time Frame: Duration of surgery ]
  • Number of blood units transfused [ Time Frame: Duration of surgery ]
  • Rate of surgical infections [ Time Frame: Duration of hospital stay ]
  • Length of hospital stay [ Time Frame: Duration of hospital stay ]
  • Time until start of rehabilitation program [ Time Frame: Up to 3 weeks post-surgery ]
  • 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.
Same as current
  • Shoulder outcome scores [ Time Frame: 6 months post-surgery ]
    Shoulder outcome scores will include a PENN derived ASES form.
  • General outcome scores [ Time Frame: 6 months post-surgery ]
    General outcome measures will include EQ-5D, GROC and SANE forms.
  • Hip outcome scores [ Time Frame: 6 months ]
    Hip outcome measurements will include Harris Hip score and the WOMAC forms.
Same as current
 
Topical Tranexamic Acid (TXA) in Joint Arthroplasty
Topical Application of Tranexamic Acid in Joint Arthroplasty
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Osteoarthritis
  • Hip Arthropathy
  • Shoulder Arthropathy
  • Biological: Tranexaminic Acid (TXA)
    1.5g of TXA in 100ml normal saline solution
    Other Name: Cyklokapron
  • Drug: Normal saline
  • Experimental: Antifibrinolytic agent
    Tranexaminic acid (TXA)
    Intervention: Biological: Tranexaminic Acid (TXA)
  • Placebo Comparator: Saline
    Normal saline
    Intervention: Drug: Normal saline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
180
December 2016
September 2016   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Carlisle Shealy, BS 864-454-7458 carlisle.shealy@hawkinsfoundation.com
United States
 
 
NCT01937559
Pro00021253
Yes
Not Provided
Not Provided
The Hawkins Foundation
The Hawkins Foundation
Not Provided
Principal Investigator: Brian Burnikel, MD Steadman Hawkins Clinic of the Carolinas - Greenville Health System
The Hawkins Foundation
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP