OsteoarthritisPhase 4NCT01873768
Clinical Efficacy of Tranexamic Acid and ε-Aminocaproic Acid in Reducing Blood Loss Following Total Knee Replacement
A Phase 4 study testing Tranexamic Acid (TXA) and ε-Aminocaproic Acid (EACA) in people with Osteoarthritis, run by Miller Orthopedic Specialists at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Tranexamic Acid (TXA) and ε-Aminocaproic Acid (EACA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Dec 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Persons aged 18 - 90 years who are scheduled to undergo a unilateral total knee replacement surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Miller Orthopedic Specialists
Council Bluffs, Iowa, 51503
About this study
Official title: A Randomized Controlled Trial of Tranexamic Acid and ε-Aminocaproic Acid to Reduce Blood Loss Following Total Knee Arthroplasty
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.
- Conditions
- Osteoarthritis
- Being tested
- Tranexamic Acid (TXA), ε-Aminocaproic Acid (EACA)
- Keywords
- Tranexamic acid, 6-Aminocaproic Acid, Arthroplasty, Osteoarthritis, Arthritis, Joint Diseases, Musculoskeletal Diseases, Rheumatic Diseases, Antifibrinolytic Agents, Fibrin Modulating Agents, Pharmacologic Actions, Coagulants, Therapeutic Uses
- Medical subject headings
- Osteoarthritis, Arthritis, Joint Diseases, Musculoskeletal Diseases, Rheumatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic Acid (TXA)Drug
Also called Cyklokapron
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.
ε-Aminocaproic Acid (EACA)Drug
Also called Amicar
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: ε-Aminocaproic Acid (EACA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transfusion rate
Measured: 1.5 to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2013 (estimated)
- Study startJan 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Miller Orthopedic Specialists
- Sponsor type
- University, hospital or other
- Collaborators
- CHI Health Mercy Hospital, Creighton University Medical Center
- Responsible party
- Sponsor
- Investigators
- Clifford K Boese, MD, Principal investigator, Miller Orthopedic Specialists
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01873768
- Sponsor's protocol ID
- MOS-16735
- Other IDs
- MOS1316735
- Status last verified
- Mar 2016
- First submitted
- 6 Jun 2013
- Last updated
- 21 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Tranexamic Acid and ε-Aminocaproic Acid to Reduce Blood Loss Following Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT01873768
- Acronym / sponsor ID
- MOS-16735
- Conditions
- Osteoarthritis
- Keywords
- Tranexamic acid, 6-Aminocaproic Acid, Arthroplasty, Osteoarthritis, Arthritis, Joint Diseases, Musculoskeletal Diseases, Rheumatic Diseases
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- Miller Orthopedic SpecialistsUniversity, hospital or other
- Collaborators
- CHI Health Mercy Hospital, Creighton University Medical Center
- Study start
- Jan 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 10 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tranexamic acid (TXA) | Active comparator | Drug: 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. |
| ε-Aminocaproic Acid (EACA) | Active comparator | Drug: 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Persons aged 18 - 90 years who are scheduled to undergo a unilateral total knee replacement surgery
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic Acid (TXA)Also: Cyklokapron1g 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. | Drug | Tranexamic acid (TXA) |
| ε-Aminocaproic Acid (EACA)Also: Amicar7g 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. | Drug | ε-Aminocaproic Acid (EACA) |
Primary outcome
Transfusion rate
Time frame: 1.5 to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clifford K Boese, MD principal investigator
Miller Orthopedic Specialists
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tranexamic Acid (TXA) and ε-Aminocaproic Acid (EACA) in people with Osteoarthritis, run by Miller Orthopedic Specialists at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transfusion rate (time frame: 1.5 to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2016.