Epsilon Aminocaproic Acid Vs. Tranexamic Acid Vs. Placebo for Prevention of Blood Loss in Total Knee Arthroplasty

NCT01527968 | Unknown

• 1 other identifier: 242119
• Study Type: interventional
• Target: 54
• Locations: 0 countries
• Sites: N/A

Brief Summary

TXA and EACA have been reported to reduce blood loss in cardiac and neuro surgery, but there is no literature available comparing the two in total knee arthroplasty (TKA). The investigators want to determine if TXA or EACA compared with placebo are effective and safe for blood loss prevention in TKA by comparing blood loss, transfusion rates, and total cost.

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Blood loss until the drain is removed

  24 hours

Study Arms (3)

Tranexamic Acid

ACTIVE COMPARATOR

TXA as 10mg/kg x 1 dose in 100mL normal saline over 15 minutes prior to the procedure then an infusion of 1mg/kg/hr during the procedure + placebo (normal saline as the dummy for eACA.)

Drug: Tranexamic Acid

Epsilon Aminocaproic Acid

ACTIVE COMPARATOR

eACA as 150mg/kg in 250mL of IV normal saline over 15 minutes prior to the procedure then an infusion of 15mg/kg/hr during the procedure + placebo (normal saline as the dummy for TXA).

Drug: Epsilon Aminocaproic Acid

Placebo

PLACEBO COMPARATOR

Control Normal Saline x 2 infusions as the double dummy for TXA and eACA.

Drug: Normal Saline

Interventions

Tranexamic Acid DRUG

TXA as 10mg/kg x 1 dose in 100mL normal saline over 15 minutes prior to the procedure then an infusion of 1mg/kg/hr during the procedure + placebo (normal saline as the dummy for eACA.)

Tranexamic Acid

Epsilon Aminocaproic Acid DRUG

eACA as 150mg/kg in 250mL of IV normal saline over 15 minutes prior to the procedure then an infusion of 15mg/kg/hr during the procedure + placebo (normal saline as the dummy for TXA).

Epsilon Aminocaproic Acid

Normal Saline DRUG

Control Normal Saline x 2 infusions as the double dummy for TXA and eACA.

Placebo

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients scheduled to receive primary unilateral total knee arthroplasty

You may not qualify if:

• Subject requires bilateral staged total knee arthroplasty
• Religious beliefs that would limit blood transfusion
• History of acquired defective color vision (inhibits monitoring for adverse events)
• Patients with a known history of upper urinary tract bleeding
• History of abnormal coagulation
• Renal dysfunction defined by elevated BUN and CR or BUN to CR ratio of 20:1 within 30 days of surgery
• Active intravascular clotting
• Known allergy to either TXA or eACA
• Myocardial Infarct within 6 months
• History of stroke
• Patient is a prisoner

Sponsors & Collaborators

• Heekin Orthopedic Research Institute: lead

MeSH Terms

Conditions

Osteoarthritis

Interventions

Tranexamic Acid; Aminocaproic Acid; Saline Solution

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Aminocaproates; Caproates; Acids, Acyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• R. David Heekin, M.D.

  Heekin Institute for Orthopedic Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 3, 2012
• First Posted: February 7, 2012
• Study Start: April 1, 2012
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: July 26, 2016

Record last verified: 2016-07