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Completed

NCT Number: NCT02030821

TXA vs. Amicar in Total Knee and Hip Arthroplasty

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.

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Key information

Conditions

Blood Loss Hemorrhage Hip Arthritis Knee Arthritis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Duke University Medical Center

Durham, North Carolina, 27708, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Amicar

Drug

Subjects randomized to receive Amicar will receive this during surgical intervention

Other names: Aminocaproic Acid

TXA

Drug

Subjects randomized to receive TXA will receive this during surgical intervention

Other names: Tranexamic Acid

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

TXA (Tranexamic Acid) vs. Amicar (Aminocaproic Acid) in Total Knee and Hip Arthroplasty- Effectiveness, Safety, and Cost Analysis

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jan 9, 2014
Registry last updated
Dec 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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