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Trial record 12 of 36 for:    AMINOCAPROIC ACID

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

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.


Condition or disease Intervention/treatment Phase
Blood Loss Hip Arthritis Knee Arthritis Drug: Amicar Drug: TXA Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 246 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: TXA (Tranexamic Acid) vs. Amicar (Aminocaproic Acid) in Total Knee and Hip Arthroplasty- Effectiveness, Safety, and Cost Analysis
Study Start Date : January 2015
Actual Primary Completion Date : November 12, 2017
Actual Study Completion Date : November 12, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

Drug: TXA
Subjects randomized to receive TXA will receive this during surgical intervention
Other Name: Tranexamic Acid

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.

Drug: Amicar
Subjects randomized to receive Amicar will receive this during surgical intervention
Other Name: Aminocaproic Acid




Primary Outcome Measures :
  1. 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 ]
  2. Number of Transfusions [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days ]
  3. 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 ]

Secondary Outcome Measures :
  1. Length of Hospitalization Stay [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days ]
  2. Cost of Hospitalization [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days ]


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

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

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): NCT02030821


Locations
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United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27708
Sponsors and Collaborators
Duke University
  Study Documents (Full-Text)

Documents provided by Duke University:

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02030821     History of Changes
Other Study ID Numbers: Pro00050108
First Posted: January 9, 2014    Key Record Dates
Results First Posted: December 5, 2018
Last Update Posted: December 5, 2018
Last Verified: November 2018
Additional relevant MeSH terms:
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Arthritis
Joint Diseases
Musculoskeletal Diseases
Tranexamic Acid
Aminocaproic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants