NCT01873768

Brief Summary

Tranexamic acid (TXA) and ε-aminocaproic acid (EACA) are two drugs shown to limit blood loss following major surgery, from cardiac to orthopedic procedures. Yet compared to tranexamic acid (TXA), research on the clinical impact of ε-aminocaproic acid (EACA) in total knee arthroplasty (TKA) is limited. The primary aim of this study is to determine whether TXA and EACA provide similar blood decreasing effects following TKA or whether one drug provides a superior effect over the other in reducing patients' blood loss.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
194

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 10, 2013

Completed
7 months until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

March 21, 2016

Status Verified

March 1, 2016

Enrollment Period

1.9 years

First QC Date

June 6, 2013

Last Update Submit

March 18, 2016

Conditions

Osteoarthritis

Keywords

Tranexamic acid6-Aminocaproic AcidArthroplastyOsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesAntifibrinolytic AgentsFibrin Modulating AgentsPharmacologic ActionsCoagulantsTherapeutic Uses

Outcome Measures

Primary Outcomes (1)

  • Transfusion rate

    1.5 to 2 years

Study Arms (2)

Tranexamic acid (TXA)

ACTIVE COMPARATOR

1g in 50ml of saline given over 30 minutes just prior to raising the tourniquet and making the initial incision. A second 1g in 50ml of saline will be infused over 30 minutes beginning at the time of wound closure.

Drug: Tranexamic Acid (TXA)

ε-Aminocaproic Acid (EACA)

ACTIVE COMPARATOR

7g in 50ml of saline given over 30 minutes just prior to raising the tourniquet and making the initial incision. A second 7g of EACA in 50ml saline will be infused over 30 minutes beginning at the time of wound closure.

Drug: ε-Aminocaproic Acid (EACA)

Interventions

Tranexamic Acid (TXA)DRUG

1g in 250cc of saline given over 30 minutes just prior to raising the tourniquet and making the initial incision. A second 1g in 250cc of saline will be infused over 30 minutes beginning at the time of wound closure.

Also known as: Cyklokapron
Tranexamic acid (TXA)
ε-Aminocaproic Acid (EACA)DRUG

7g in 250cc of saline given over 30 minutes just prior to raising the tourniquet and making the initial incision. A second 7g of EACA in 250cc saline will be infused over 30 minutes beginning at the time of wound closure.

Also known as: Amicar
ε-Aminocaproic Acid (EACA)

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Persons aged 18 - 90 years who are scheduled to undergo a unilateral total knee replacement surgery

You may not qualify if:

  • Non-English speaking individuals
  • Individuals with a history of deep vein thrombosis or pulmonary embolism within one year
  • Individuals with a history of coagulopathy
  • Heart stent within one year
  • Pre-operative autologous blood donation
  • Unwilling or unable to take Coumadin for deep vein thrombosis (DVT) prophylaxis
  • Received nonsteroidal anti-inflammatory drug (NSAID) or platelet antiaggregant treatment within five days prior to surgery
  • Pre-operative creatinine greater than 1.5mg/dL

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Miller Orthopedic Specialists

Council Bluffs, Iowa, 51503, United States

Location

MeSH Terms

Conditions

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Interventions

Tranexamic AcidAminocaproic Acid

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsAminocaproatesCaproatesAcids, AcyclicAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Clifford K Boese, MD

    Miller Orthopedic Specialists

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2013

First Posted

June 10, 2013

Study Start

January 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

March 21, 2016

Record last verified: 2016-03

Locations

US(1)