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Trial record 7 of 36 for:    AMINOCAPROIC ACID

Clinical Efficacy of Tranexamic Acid and ε-Aminocaproic Acid in Reducing Blood Loss Following Total Knee Replacement

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ClinicalTrials.gov Identifier: NCT01873768
Recruitment Status : Completed
First Posted : June 10, 2013
Last Update Posted : March 21, 2016
Sponsor:
Collaborators:
CHI Health Mercy Hospital
Creighton University Medical Center
Information provided by (Responsible Party):
Miller Orthopedic Specialists

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Drug: Tranexamic Acid (TXA) Drug: ε-Aminocaproic Acid (EACA) Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 194 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Tranexamic Acid and ε-Aminocaproic Acid to Reduce Blood Loss Following Total Knee Arthroplasty
Study Start Date : January 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Active Comparator: Tranexamic acid (TXA)
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)
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.
Other Name: Cyklokapron

Active Comparator: ε-Aminocaproic Acid (EACA)
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)
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.
Other Name: Amicar




Primary Outcome Measures :
  1. Transfusion rate [ Time Frame: 1.5 to 2 years ]


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01873768


Locations
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United States, Iowa
Miller Orthopedic Specialists
Council Bluffs, Iowa, United States, 51503
Sponsors and Collaborators
Miller Orthopedic Specialists
CHI Health Mercy Hospital
Creighton University Medical Center
Investigators
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Principal Investigator: Clifford K Boese, MD Miller Orthopedic Specialists

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Responsible Party: Miller Orthopedic Specialists
ClinicalTrials.gov Identifier: NCT01873768     History of Changes
Other Study ID Numbers: MOS-16735
MOS1316735 ( Other Identifier: Miller Orthopedic Specialists )
First Posted: June 10, 2013    Key Record Dates
Last Update Posted: March 21, 2016
Last Verified: March 2016
Keywords provided by Miller Orthopedic Specialists:
Tranexamic acid
6-Aminocaproic Acid
Arthroplasty
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Antifibrinolytic Agents
Fibrin Modulating Agents
Pharmacologic Actions
Coagulants
Therapeutic Uses
Additional relevant MeSH terms:
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Tranexamic Acid
Aminocaproic Acid
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants