Comparison of Tranexamic to Epsilon Aminocaproic Acid: a Prospective Analysis of Blood Conservation in Cardiac Surgery

NCT01248104 | Completed Results

• 1 other identifier: 5100064
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

We designed a prospective double-blinded randomized trial in an attempt to detect a difference between tranexamic acid (TXA) and epsilon aminocaproic acid (EACA) in reducing transfusion in patients undergoing cardiac surgery.

Conditions

Cardiopulmonary Bypass

Keywords

Cardiac Surgery; Antifibrinolytic agents; Blood transfusion; epsilon aminocaproic acid; tranexamic acid

Outcome Measures

Primary Outcomes (1)

• Total Transfusion Amounts

  The outcome measure was the intergroup difference in total transfusion amounts up to post-operative day 2.

  48 hours

Study Arms (2)

Tranexamic Acid

ACTIVE COMPARATOR

The research pharmacist used computer randomization to assign patients to receive either TXA or EACA. The TXA group re- ceived a bolus of 10 mg / kg over 15 minutes fol- lowed by an infusion of 1 mg/kg/hr.

Drug: Tranexamic Acid

Aminocaproic Acid

ACTIVE COMPARATOR

The research pharmacist used computer randomization to assign patients to receive either TXA or EACA. The EACA group received a bolus of 100 mg / kg given over 15 minutes shortly after induction of anesthesia followed by an infusion of 10 mg/kg/hr.

Drug: Aminocaproic Acid

Interventions

Tranexamic Acid DRUG

Infusion during cardiac surgery

Also known as: TXA

Tranexamic Acid

Aminocaproic Acid DRUG

Infusion during cardiac surgery

Also known as: Amicar

Aminocaproic Acid

Eligibility Criteria

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

You may qualify if:

• Is the subject 18 years of age or older?
• Is the subject scheduled for primary cardiac surgery utilizing cardiopulmonary bypass(CPB)?
• Is the subject more than 30 kg ( 66 lbs)?
• Does subject understand English?

You may not qualify if:

• Does the subject have existing coagulation defects (INR \> 1.5, platelets \< 100 ?
• Does the subject have renal failure (defined as BUN/Cr ratio 20:1 ?
• Does the subject have severe liver disease (AST \& ALT\> 3x normal) ?
• Is the subject having emergency cardiac surgery, complex aortic surgery, combination valve/CABG surgeries, or redo cardiac surgery?
• Is the subject having any procedure where CPB is not anticipated?
• Is the patient weight greater than 150 kg?

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

MeSH Terms

Interventions

Tranexamic Acid; Aminocaproic Acid

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Jason Gatling
• Organization: Loma Linda University Medical Center

jgatling@llu.edu

909-558-4475

Study Officials

• Jason Gatling, MD

  Loma Linda University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: November 15, 2010
• First Posted: November 25, 2010
• Study Start: March 1, 2010
• Primary Completion: March 1, 2013
• Study Completion: February 1, 2015
• Last Updated: October 19, 2020
• Results First Posted: August 26, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)