TXA vs. Amicar in Total Knee and Hip Arthroplasty

NCT02030821 | Completed Phase 4 Results

• 1 other identifier: Pro00050108
• Study Type: interventional
• Target: 246
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Loss; Hip Arthritis; Knee Arthritis

Outcome Measures

Primary Outcomes (3)

• Total Blood Loss Over Course of Stay (Intraoperative and Postoperatively Until Discharge)

  Participants will be followed for the duration of hospital stay, an expected average of 5 days

• Number of Transfusions

  Participants will be followed for the duration of hospital stay, an expected average of 5 days

• Difference in Preoperative and Lowest Postoperative Hemoglobin

  Participants will be followed for the duration of hospital stay, an expected average of 5 days

Secondary Outcomes (2)

• Length of Hospitalization Stay

  Participants will be followed for the duration of hospital stay, an expected average of 5 days

• Cost of Hospitalization

  Participants will be followed for the duration of hospital stay, an expected average of 5 days

Study Arms (2)

Tranexamic Acid (TXA)

ACTIVE COMPARATOR

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

Epsilon-aminocaproic acid (Amicar)

ACTIVE COMPARATOR

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

Interventions

Amicar DRUG

Subjects randomized to receive Amicar will receive this during surgical intervention

Also known as: Aminocaproic Acid

Epsilon-aminocaproic acid (Amicar)

TXA DRUG

Subjects randomized to receive TXA will receive this during surgical intervention

Also known as: Tranexamic Acid

Tranexamic Acid (TXA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients electing to undergo primary total hip or knee arthroplasty

You may not qualify if:

• History of stents
• Myocardial infarction,
• Cerebrovascular accident or stroke
• Deep venous thrombus
• Pulmonary embolus
• Late onset color blindness
• Hypercoagulable state

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27708, United States

Location

MeSH Terms

Conditions

Hemorrhage

Interventions

Aminocaproic Acid; Tranexamic Acid

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aminocaproates; Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Cyclohexanecarboxylic Acids; Acids, Carbocyclic

Results Point of Contact

• Title: Michael Bolognesi, M.D.
• Organization: Duke University

michael.bolognesi@duke.edu

919-668-4732

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2014
• First Posted: January 9, 2014
• Study Start: January 1, 2015
• Primary Completion: November 12, 2017
• Study Completion: November 12, 2017
• Last Updated: December 5, 2018
• Results First Posted: December 5, 2018

Record last verified: 2018-11

Locations

US (1)