OsteoarthritisPhase 3NCT02438566
Non-inferiority Trial of Oral Tranexamic Acid vs. Intravenous Tranexamic Acid in Joint Replacement Surgery
A Phase 3 study testing Tranexamic Acid (Oral) and Tranexamic Acid (Intravenous) in people with Osteoarthritis and Blood Loss, Surgical, run by The New England Baptist Hospital at 1 site in United States.
Trial summary
The purpose of this research is to determine if the oral form of a medication (tranexamic acid) to reduce bleeding can be used in place of an intravenous (IV) form, to learn the best way to give tranexamic acid: either a pill by mouth, or a solution by vein. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Blood Loss, Surgical, Blood Loss, Postoperative
- What is being tested?
- Tranexamic Acid (Oral) and Tranexamic Acid (Intravenous)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Apr 2017
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be included into this study, you must be undergoing hip or bilateral knee replacement surgery.
- You must be healthy enough to undergo joint replacement surgery.
- You must be able to understand and sign an informed consent.
- You must be at least 18 years of age.
Who cannot join
- You cannot be under 18 years of age.
- You cannot be undergoing revision hip or revision bilateral knee replacement surgery.
- You cannot be part of this study if you are allergic to the medication
- You cannot participate if you are on hemodialysis,
- You cannot participate if you have active coronary artery disease and if you have various vascular stents in place.
- You will also be excluded if you have ever had a blood clot (deep vein thrombosis (DVT), pulmonary embolism (PE)).
- You will also be excluded if you have ever had a cerebral or subarachnoid hemorrhage (brain bleeding), or stroke (cerebral vascular accident or transient ischemic attack).
- If you are on estrogen-containing medication (hormone replacement therapy or oral contraceptive) within 7 days of surgery, you cannot take part in this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
New England Baptist Hospital
Boston, Massachusetts, 02120
About this study
Official title: Non-inferiority Trial of Oral Tranexamic Acid (OTA) vs. Intravenous Tranexamic Acid (IVTA) to Prevent Blood Loss in Joint Replacement Surgery
The purpose of this research is to determine if the oral form of a medication (tranexamic acid) to reduce bleeding can be used in place of an intravenous (IV) form, to learn the best way to give tranexamic acid: either a pill by mouth, or a solution by vein.
Read the detailed description
The purpose of this research is to determine if the oral form of a medication (tranexamic acid) to reduce bleeding can be used in place of an intravenous (IV) form.to learn the best way to give tranexamic acid: either a pill by mouth, or a solution by vein. Tranexamic acid is a medicine that reduces blood loss and reduces the need for blood transfusions in surgery. This drug is not experimental and has been used widely to treat patients in many settings, including orthopedic procedures, to reduce bleeding. This medication is now part of the standard of care at many centers in the U.S. and around the world. Orthopedic procedures have used iv tranexamic acid more often, but there are reasons to believe that the oral form may be at least equivalent and perhaps better at lower cost to the health care system. No other study has yet performed a systematic comparison to answer the question.
- Being tested
- Tranexamic Acid (Oral), Tranexamic Acid (Intravenous)
- Keywords
- Tranexamic Acid, Blood Loss, Total Hip Replacement, Bilateral Knee Replacement
- Medical subject headings
- Osteoarthritis, Blood Loss, Surgical, Postoperative Hemorrhage, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic Acid (Oral)Drug
Also called trans-4-(aminomethyl)cyclohexanecarboxylic acid, Lysteda
OTA will be given as 1950 mg 1-2 hours prior to OR and 1950 mg 2 hours after surgical close, before discharge from PACU.
Tranexamic Acid (Intravenous)Drug
Also called trans-4-(aminomethyl)cyclohexanecarboxylic acid, Cyklokapron
IVTA will be given as 1 g intravenously at time of first incision (THA or bTKA without tourniquet) or just before 1st tourniquet application (bTKA), and then again, 1 g after final surgery closure.
| Study group | Role | What they receive |
|---|---|---|
| Oral Tranexamic Acid (OTA) | Active comparator | Subjects will be randomized 1:1 to receive either IVTA or OTA with corresponding placebos. OTA will be given as 1950 mg 1-2 hours prior to OR and 1950 mg 2 hours after surgical close, before discharge from PACU. Receives: Drug: Tranexamic Acid (Oral) |
| Intravenous Tranexamic Acid (IVTA) | Active comparator | Subjects will be randomized 1:1 to receive either IVTA or OTA with corresponding placebos. IVTA will be given as 1 g intravenously at time of first incision (THA or bTKA without tourniquet) or just before 1st tourniquet application (bTKA), and then again, 1 g after final surgery closure. Receives: Drug: Tranexamic Acid (Intravenous) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower number of units of blood required for transfusion.
Lower number of units of blood required for transfusion in the OR and post-operatively, hospital-wide.
Measured: 2 Years
Secondary outcomes (3)
Lower incidences of patients requiring blood transfusion.
Lower incidences of patients requiring blood transfusion in the OR, or post-operatively.
Measured: 2 Years
Lower Blood Loss in Patients
Lower amounts of blood loss in patients during in surgery, and post-operatively.
Measured: Hospital Stay: 1-3 days.
Length of Stay
Potential for a shorter length of hospital stay for post-surgical patients.
Measured: 1-3 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2015 (estimated)
- Study startApr 2015
- Primary completionApr 2016 (estimated)
- Study completionApr 2017 (estimated)
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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- The New England Baptist Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenneth Bauer, The New England Baptist Hospital
- Investigators
- Kenneth Bauer, MD, Principal investigator, New England Baptist Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02438566
- Sponsor's protocol ID
- 654455
- Status last verified
- Mar 2016
- First submitted
- 14 Apr 2015
- Last updated
- 22 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-inferiority Trial of Oral Tranexamic Acid (OTA) vs. Intravenous Tranexamic Acid (IVTA) to Prevent Blood Loss in Joint Replacement Surgery
- ClinicalTrials.gov ID
- NCT02438566
- Acronym / sponsor ID
- 654455
- Keywords
- Tranexamic Acid, Blood Loss, Total Hip Replacement, Bilateral Knee Replacement
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 118 participants (actual)
- Lead sponsor
- The New England Baptist HospitalUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 8 May 2015 (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.
The purpose of this research is to determine if the oral form of a medication (tranexamic acid) to reduce bleeding can be used in place of an intravenous (IV) form, to learn the best way to give tranexamic acid: either a pill by mouth, or a solution by vein.
Detailed description
The purpose of this research is to determine if the oral form of a medication (tranexamic acid) to reduce bleeding can be used in place of an intravenous (IV) form.to learn the best way to give tranexamic acid: either a pill by mouth, or a solution by vein. Tranexamic acid is a medicine that reduces blood loss and reduces the need for blood transfusions in surgery. This drug is not experimental and has been used widely to treat patients in many settings, including orthopedic procedures, to reduce bleeding. This medication is now part of the standard of care at many centers in the U.S. and around the world. Orthopedic procedures have used iv tranexamic acid more often, but there are reasons to believe that the oral form may be at least equivalent and perhaps better at lower cost to the health care system. No other study has yet performed a systematic comparison to answer the question.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Tranexamic Acid (OTA) | Active comparator | Drug: Tranexamic Acid (Oral)Subjects will be randomized 1:1 to receive either IVTA or OTA with corresponding placebos. OTA will be given as 1950 mg 1-2 hours prior to OR and 1950 mg 2 hours after surgical close, before discharge from PACU. |
| Intravenous Tranexamic Acid (IVTA) | Active comparator | Drug: Tranexamic Acid (Intravenous)Subjects will be randomized 1:1 to receive either IVTA or OTA with corresponding placebos. IVTA will be given as 1 g intravenously at time of first incision (THA or bTKA without tourniquet) or just before 1st tourniquet application (bTKA), and then again, 1 g after final surgery closure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- To be included into this study, you must be undergoing hip or bilateral knee replacement surgery.
- You must be healthy enough to undergo joint replacement surgery.
- You must be able to understand and sign an informed consent.
- You must be at least 18 years of age.
Key exclusion criteria (8 listed)
- You cannot be under 18 years of age.
- You cannot be undergoing revision hip or revision bilateral knee replacement surgery.
- You cannot be part of this study if you are allergic to the medication
- You cannot participate if you are on hemodialysis,
- You cannot participate if you have active coronary artery disease and if you have various vascular stents in place.
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 (Oral)Also: trans-4-(aminomethyl)cyclohexanecarboxylic acid, LystedaOTA will be given as 1950 mg 1-2 hours prior to OR and 1950 mg 2 hours after surgical close, before discharge from PACU. | Drug | Oral Tranexamic Acid (OTA) |
| Tranexamic Acid (Intravenous)Also: trans-4-(aminomethyl)cyclohexanecarboxylic acid, CyklokapronIVTA will be given as 1 g intravenously at time of first incision (THA or bTKA without tourniquet) or just before 1st tourniquet application (bTKA), and then again, 1 g after final surgery closure. | Drug | Intravenous Tranexamic Acid (IVTA) |
Primary outcome
Lower number of units of blood required for transfusion.
Time frame: 2 Years
Lower number of units of blood required for transfusion in the OR and post-operatively, hospital-wide.
3 secondary outcomes
Lower incidences of patients requiring blood transfusion.
Time frame: 2 Years
Lower Blood Loss in Patients
Time frame: Hospital Stay: 1-3 days.
Length of Stay
Time frame: 1-3 Days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 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.
Kenneth Bauer, MD principal investigator
New England Baptist Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tranexamic Acid (Oral) and Tranexamic Acid (Intravenous) in people with Osteoarthritis and Blood Loss, Surgical, run by The New England Baptist Hospital 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 4 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: status not confirmed, as of the sponsor's last update on 22 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Lower number of units of blood required for transfusion. (time frame: 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 22 Mar 2016.