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TXA vs. Amicar in Total Knee and Hip Arthroplasty

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: NCT02030821
Recruitment Status : Completed
First Posted : January 9, 2014
Results First Posted : December 5, 2018
Last Update Posted : December 5, 2018
Sponsor:
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date  ICMJE January 6, 2014
First Posted Date  ICMJE January 9, 2014
Results First Submitted Date  ICMJE November 9, 2018
Results First Posted Date  ICMJE December 5, 2018
Last Update Posted Date December 5, 2018
Study Start Date  ICMJE January 2015
Actual Primary Completion Date November 12, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 9, 2018)
  • Total Blood Loss Over Course of Stay (Intraoperative and Postoperatively Until Discharge) [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days ]
  • Number of Transfusions [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days ]
  • Difference in Preoperative and Lowest Postoperative Hemoglobin [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 7, 2014)
  • Blood Loss [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days ]
  • Number of Transfusions [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days ]
  • Preoperative and lowest postoperative hematocrit and hemoglobin [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days ]
Change History Complete list of historical versions of study NCT02030821 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 7, 2014)
  • Length of Hospitalization Stay [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days ]
  • Cost of Hospitalization [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE TXA vs. Amicar in Total Knee and Hip Arthroplasty
Official Title  ICMJE TXA (Tranexamic Acid) vs. Amicar (Aminocaproic Acid) in Total Knee and Hip Arthroplasty- Effectiveness, Safety, and Cost Analysis
Brief Summary

The purpose of this study is to determine the relative effectiveness of two drug agents, Tranexamic acid (TXA) and aminocaproic acid (Amicar), that act through a similar mechanism of action. These agents are used to decrease blood loss that is a result of major surgery, like total joint arthroplasty. A secondary goal will be investigate the cost-analysis of total hospitalization. Both TXA and Amicar are both currently used in the care of patients undergoing total joint arthroplasty.

Subjects will be randomly assigned to the TXA or Amicar arm. All data needed for this study including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit and hemoglobin, and complications will be collected during the hospitalization stay.

Our Hypothesis is that TXA and Amicar will have similar effectiveness in preventing intraoperative blood loss and the need for transfusion post-op than Amicar.

A detailed cost analysis will show that the overall cost of performing the operative procedure, including transfusions, OR time, and total costs associated with admission cost will be more decreased with Amicar as compared to TXA.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Blood Loss
  • Hip Arthritis
  • Knee Arthritis
Intervention  ICMJE
  • Drug: Amicar
    Subjects randomized to receive Amicar will receive this during surgical intervention
    Other Name: Aminocaproic Acid
  • Drug: TXA
    Subjects randomized to receive TXA will receive this during surgical intervention
    Other Name: Tranexamic Acid
Study Arms  ICMJE
  • Active Comparator: Tranexamic Acid (TXA)

    TXA will be administered as a 1 gm dose IV prior to the procedure then as a repeat dose of 1 gram at the time of wound closure. These doses are currently used at Duke for Total Knee Arthroplasties (TKAs) and Total Hip Arthroplasties (THAs) per standard of care by the orthopaedic team.

    All data needed for this study including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit and hemoglobin, and complications will be collected during the hospitalization.

    Intervention: Drug: TXA
  • Active Comparator: Epsilon-aminocaproic acid (Amicar)

    Administered 5g in 250mL of IV normal saline over 15 minutes prior to the procedure and then an infusion of 5g at the time of wound closure. These doses are currently used at Duke for Total Knee Arthroplasties (TKAs) and Total Hip Arthroplasties (THAs) per standard of care by the orthopaedic team.

    All data needed for this study including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit and hemoglobin, and complications will be collected during the hospitalization.

    Intervention: Drug: Amicar
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 19, 2018)
246
Original Estimated Enrollment  ICMJE
 (submitted: January 7, 2014)
400
Actual Study Completion Date  ICMJE November 12, 2017
Actual Primary Completion Date November 12, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients electing to undergo primary total hip or knee arthroplasty

Exclusion Criteria:

  • History of stents
  • Myocardial infarction,
  • Cerebrovascular accident or stroke
  • Deep venous thrombus
  • Pulmonary embolus
  • Late onset color blindness
  • Hypercoagulable state
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02030821
Other Study ID Numbers  ICMJE Pro00050108
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Duke University
Verification Date November 2018

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