BleedingPhase 3NCT02587845
Use of Transexamic Acid in Hip Replacement
A Phase 3 study testing Tranexamic Acid (IV) and Tranexamic Acid (Topical) in people with Bleeding and Transfusion Related Complication, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Studies have shown that tranexamic acid reduces blood loss and transfusion need in patients undergoing total hip arthroplasty. However, no to date, no study has been large enough to determine definitively whether the drug is safe and effective. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Bleeding, Transfusion Related Complication
- What is being tested?
- Tranexamic Acid (IV) and Tranexamic Acid (Topical)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2015to Dec 2016
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Unilateral primary THA
- Diagnosis - not fracture, elective surgery
- Revision THA
Who cannot join
- Known allergy to TNA
- Acquired or congenital coagulopathy
- Current anticoagulation therapy
- Preoperative hepatic or renal dysfunction
- Severe ischemic heart disease (Serious cardiac or respiratory disease)
- A history of thromboembolic disease
- Refusal of blood products
- Pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Samsung Medical Center
Seoul, 135-700
Youn-Soo Park, MD, 82-2-3410-3509
Sang Min Kim, MD
About this study
Official title: Use of Tranexamic Acid(TNA) in Preventing Blood Loss During and After Total Hip Arthroplasty
Studies have shown that tranexamic acid reduces blood loss and transfusion need in patients undergoing total hip arthroplasty. However, no to date, no study has been large enough to determine definitively whether the drug is safe and effective. The present study was designed to verify noninferior efficacy and safety of topical intra-articular TXA compared with intravenous TXA in primary THA.
Read the detailed description
Treatment of choice for osteoarthritis of the hip, developmental dysplasia of the hip, and osteonecrosis of the femoral head in older patients. In association with the investigators aging society, the number of patients who will need THA may increase significantly in the next few years [1]. However, in THA, considerable blood loss remains a major problem, which can lead to a need for allogeneic blood transfusion. Such transfusion of allogeneic erythrocytes is not free of adverse events and has been associated with transmission of infectious diseases, increased postoperative bacterial infection, immune sensitization, transfusion-related acute lung injury, intravascular hemolysis, transfusion-induced coagulopathy, renal failure, admission to intensive care, and even death. Several effective interventions have been developed to reduce blood loss and postoperative transfusion rates, such as preoperative autologous donation, cell salvage, controlled hypotension, regional anesthesia, and the use of erythropoietin and antifibrinolytics. The antifibrinolytics include aprotinin, tranexamic acid (TXA), and ε-aminocaproic acid, which have different mechanisms of action [8]. TXA is a synthetic derivative of the amino acid lysine and a competitive inhibitor of plasminogen activation, and thus interferes with fibrinolysis. Compared with other antifibrinolytic drugs, TXA is cheaper and safer than aprotinin and more potent than the others. Numerous studies have evaluated the use of antifibrinolytics in orthopedic surgery and have shown them to be effective in reducing blood loss. However, the available clinical trials and meta-analyses lack sufficient statistical power to determine the effectiveness of antifibrinolytic agents in total hip arthroplasty.
- Conditions
- Bleeding, Transfusion Related Complication
- Being tested
- Tranexamic Acid (IV), Tranexamic Acid (Topical)
- Keywords
- total hip arthroplasty, transexamic acid
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic Acid (IV)Drug
Also called TXA
IV tranexamic acid group were administered intravenous 10 mg/kg dose of TXA after closing the ITB.
Tranexamic Acid (Topical)Drug
Also called TXA
Topical tranexamic acid group were administered 2.0 g TXA in 100 ml of normal saline into the hemovac line after closing the ITB.
| Study group | Role | What they receive |
|---|---|---|
| IV group | Active comparator | Intravenous tranexamic acid injection Group IV tranexamic acid group were administered intravenous 10 mg/kg dose of TXA after closing the ITB. Receives: Drug: Tranexamic Acid (IV) |
| Topical group | Experimental | Intra-articular tranexamic acid injection Group Topical tranexamic acid group were administered 2.0 g TXA in 100 ml of normal saline into the hemovac line after closing the ITB. Receives: Drug: Tranexamic Acid (Topical) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding
Surgical bleeding
Measured: intraoperatively
Secondary outcomes (1)
Total Transfusion
Allogenic transfusion
Measured: 5days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BleedingStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Youn-Soo Park, Samsung Medical Center
- Investigators
- Youn Soo Park, MD, Study director, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02587845
- Sponsor's protocol ID
- 2014-01-129
- Status last verified
- Oct 2015
- First submitted
- 24 Apr 2014
- Last updated
- 27 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Tranexamic Acid(TNA) in Preventing Blood Loss During and After Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT02587845
- Acronym / sponsor ID
- 2014-01-129
- Conditions
- Bleeding, Transfusion Related Complication
- Keywords
- total hip arthroplasty, transexamic acid
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 27 Oct 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.
Studies have shown that tranexamic acid reduces blood loss and transfusion need in patients undergoing total hip arthroplasty. However, no to date, no study has been large enough to determine definitively whether the drug is safe and effective. The present study was designed to verify noninferior efficacy and safety of topical intra-articular TXA compared with intravenous TXA in primary THA.
Detailed description
Treatment of choice for osteoarthritis of the hip, developmental dysplasia of the hip, and osteonecrosis of the femoral head in older patients. In association with the investigators aging society, the number of patients who will need THA may increase significantly in the next few years [1]. However, in THA, considerable blood loss remains a major problem, which can lead to a need for allogeneic blood transfusion. Such transfusion of allogeneic erythrocytes is not free of adverse events and has been associated with transmission of infectious diseases, increased postoperative bacterial infection, immune sensitization, transfusion-related acute lung injury, intravascular hemolysis, transfusion-induced coagulopathy, renal failure, admission to intensive care, and even death. Several effective interventions have been developed to reduce blood loss and postoperative transfusion rates, such as preoperative autologous donation, cell salvage, controlled hypotension, regional anesthesia, and the use of erythropoietin and antifibrinolytics. The antifibrinolytics include aprotinin, tranexamic acid (TXA), and ε-aminocaproic acid, which have different mechanisms of action [8]. TXA is a synthetic derivative of the amino acid lysine and a competitive inhibitor of plasminogen activation, and thus interferes with fibrinolysis. Compared with other antifibrinolytic drugs, TXA is cheaper and safer than aprotinin and more potent than the others. Numerous studies have evaluated the use of antifibrinolytics in orthopedic surgery and have shown them to be effective in reducing blood loss. However, the available clinical trials and meta-analyses lack sufficient statistical power to determine the effectiveness of antifibrinolytic agents in total hip arthroplasty.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IV group | Active comparator | Drug: Tranexamic Acid (IV)Intravenous tranexamic acid injection Group IV tranexamic acid group were administered intravenous 10 mg/kg dose of TXA after closing the ITB. |
| Topical group | Experimental | Drug: Tranexamic Acid (Topical)Intra-articular tranexamic acid injection Group Topical tranexamic acid group were administered 2.0 g TXA in 100 ml of normal saline into the hemovac line after closing the ITB. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Unilateral primary THA
- Diagnosis - not fracture, elective surgery
- Revision THA
Key exclusion criteria (8 listed)
- Known allergy to TNA
- Acquired or congenital coagulopathy
- Current anticoagulation therapy
- Preoperative hepatic or renal dysfunction
- Severe ischemic heart disease (Serious cardiac or respiratory disease)
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 (IV)Also: TXAIV tranexamic acid group were administered intravenous 10 mg/kg dose of TXA after closing the ITB. | Drug | IV group |
| Tranexamic Acid (Topical)Also: TXATopical tranexamic acid group were administered 2.0 g TXA in 100 ml of normal saline into the hemovac line after closing the ITB. | Drug | Topical group |
Primary outcome
Bleeding
Time frame: intraoperatively
Surgical bleeding
1 secondary outcome
Total Transfusion
Time frame: 5days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2015.
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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.
Youn Soo Park, MD study director
Samsung Medical Center
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 (IV) and Tranexamic Acid (Topical) in people with Bleeding and Transfusion Related Complication, run by Samsung Medical Center at 1 site in South Korea.
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 3 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 27 Oct 2015. 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 South Korea. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bleeding (time frame: intraoperatively). 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 27 Oct 2015.