Blood Loss, SurgicalPhase 4NCT03019198
TRANEXAMIC ACID IN PATIENTS UNDERGOING TOTAL HIP ARTHROPLASTY IN A BRAZILIAN REFERENCE ORTHOPEDIC CENTER: A RANDOMIZED CONTROLLED TRIAL
A Phase 4 study testing Tranexamic Acid Injectable Solution in people with Blood Loss, Surgical and Tranexamic Acid Adverse Reaction, run by Instituto Nacional de Traumatologia e Ortopedia at 1 site in Brazil.
Trial summary
This study aims to analyze the efficacy of intravenous tranexamic acid (TXA) in patients undergoing total hip arthroplasty (THA). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Blood Loss, Surgical, Tranexamic Acid Adverse Reaction, Hip Replacement
- What is being tested?
- Tranexamic Acid Injectable Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 256 participants
- Where
- 1 siteBrazil
- Study dates
- Dec 2013to Mar 2016
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Consecutive patients who need total hip replacement were included in the initial sample. There was no age limit or restriction regarding gender for admission to the study.
Who cannot join
- Patients who underwent previous surgery in the same joint, evidence of joint infection, congenital or acquired coagulopathies, active intravascular coagulation, acute occlusive vasculopathy, hypersensitivity to TXA, chronic use of oral and steroid anticoagulants, history of severe or moderate allergy to plasma transfusion, chronic heart disease, malignant neoplasms and autoimmune diseases, patients who needed bone graft or underwent hip arthroplasty revision surgeries, and who did not consent to participate in the study
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto Nacional de Traumatologia e Ortopedia
Rio de Janeiro, Rio de Janeiro, 20940070
About this study
This study aims to analyze the efficacy of intravenous tranexamic acid (TXA) in patients undergoing total hip arthroplasty (THA).
Read the detailed description
This was a prospective, experimental, randomized, controlled study of 308 consecutive patients who underwent primary THA from December 2013 to March 2014. 256 volunteers remained in the study, 128 were treated 15 mg/kg intravenous bolus of TXA and 128 did not receive the medication. Participants were followed up at 3 weeks, 3 months, 6 months, 1 year, and then annually after surgery.
The use of TXA resulted in lesser reduction in hemoglobin and hematocrit levels, reduced blood loss, blood transfusion rate, volume of blood products, and stay length even in risk factor patients.
TXA protects risk factor patients against intra and postoperative bleeding and reduces transfusion rates.
- Being tested
- Tranexamic Acid Injectable Solution, Placebo - Concentrate
- Keywords
- Tranexamic Acid, Blood loss, Tranfusion
- Medical subject headings
- Blood Loss, Surgical, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic Acid Injectable SolutionDrug
Also called Lysteda, Transamin
Intravenous 15 mg per kilogram tranexamic acid
Placebo - ConcentrateDrug
| Study group | Role | What they receive |
|---|---|---|
| TXA | Experimental | Performed an intravenous bolus administration of 15 mg/kg of TXA to the volunteers after the end of the anesthesia and 15 minutes prior to skin incision. Receives: Drug: Tranexamic Acid Injectable Solution |
| Control | Placebo comparator | This group underwent the same procedures of the TXA group, excepting the preoperative administration of the medication. Receives: Drug: Placebo - Concentrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin drop
Measured: 24 hours post operative
Hematocrit drop
Measured: 24 hours post operative
Blood transfusion rate
Measured: 5 days
Operative blood loss
Measured: 24 hours post operative
Secondary outcomes (3)
Length of stay in hospital
Measured: 7 days
Systemic adverse events
Measured: 1 year
Thromboembolic efects
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2017 (estimated)
- Study startDec 2013
- Primary completionMar 2014
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blood Loss, SurgicalStudies 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, Care provider
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Traumatologia e Ortopedia
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Osamu de Sandes Kimura, Instituto Nacional de Traumatologia e Ortopedia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03019198
- Sponsor's protocol ID
- 06554913.0.0000.5273
- Status last verified
- Mar 2017
- First submitted
- 10 Jan 2017
- Last updated
- 9 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Kimura OS, Freitas EH, Duarte ME, Cavalcanti AS, Fernandes MB. Tranexamic acid use in high-risk blood transfusion patients undergoing total hip replacement: a randomised controlled trial. Hip Int. 2021 Jul;31(4):456-464. doi: 10.1177/1120700019889947. Epub 2019 Dec 9.
PubMed 31814452
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRANEXAMIC ACID IN PATIENTS UNDERGOING TOTAL HIP ARTHROPLASTY IN A BRAZILIAN REFERENCE ORTHOPEDIC CENTER: A RANDOMIZED CONTROLLED TRIAL
- ClinicalTrials.gov ID
- NCT03019198
- Acronym / sponsor ID
- 06554913.0.0000.5273
- Keywords
- Tranexamic Acid, Blood loss, Tranfusion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- Instituto Nacional de Traumatologia e OrtopediaOther government
- Study start
- Dec 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 12 Jan 2017 (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.
This study aims to analyze the efficacy of intravenous tranexamic acid (TXA) in patients undergoing total hip arthroplasty (THA).
Detailed description
This was a prospective, experimental, randomized, controlled study of 308 consecutive patients who underwent primary THA from December 2013 to March 2014. 256 volunteers remained in the study, 128 were treated 15 mg/kg intravenous bolus of TXA and 128 did not receive the medication. Participants were followed up at 3 weeks, 3 months, 6 months, 1 year, and then annually after surgery.
The use of TXA resulted in lesser reduction in hemoglobin and hematocrit levels, reduced blood loss, blood transfusion rate, volume of blood products, and stay length even in risk factor patients.
TXA protects risk factor patients against intra and postoperative bleeding and reduces transfusion rates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TXA | Experimental | Drug: Tranexamic Acid Injectable SolutionPerformed an intravenous bolus administration of 15 mg/kg of TXA to the volunteers after the end of the anesthesia and 15 minutes prior to skin incision. |
| Control | Placebo comparator | Drug: Placebo - ConcentrateThis group underwent the same procedures of the TXA group, excepting the preoperative administration of the medication. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Consecutive patients who need total hip replacement were included in the initial sample. There was no age limit or restriction regarding gender for admission to the study.
Key exclusion criteria (1 listed)
- Patients who underwent previous surgery in the same joint, evidence of joint infection, congenital or acquired coagulopathies, active intravascular coagulation, acute occlusive vasculopathy, hypersensitivity to TXA, chronic use of oral and steroid anticoagulants, history of severe or moderate allergy to plasma transfusion, chronic heart disease, malignant neoplasms and autoimmune diseases, patients who needed bone graft or underwent hip arthroplasty revision surgeries, and who did not consent to participate in the study
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 Injectable SolutionAlso: Lysteda, TransaminIntravenous 15 mg per kilogram tranexamic acid | Drug | TXA |
| Placebo - Concentrate | Drug | Control |
Primary outcome
Hemoglobin drop
Time frame: 24 hours post operative
Hematocrit drop
Time frame: 24 hours post operative
Blood transfusion rate
Time frame: 5 days
Operative blood loss
Time frame: 24 hours post operative
3 secondary outcomes
Length of stay in hospital
Time frame: 7 days
Systemic adverse events
Time frame: 1 year
Thromboembolic efects
Time frame: 1 year
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 9 Mar 2017.
- Derived from this study: PubMed 31814452Kimura OS, Freitas EH, Duarte ME, Cavalcanti AS, Fernandes MB. Tranexamic acid use in high-risk blood transfusion patients undergoing total hip replacement: a randomised controlled trial. Hip Int. 2021 Jul;31(4):456-464. doi: 10.1177/1120700019889947. Epub 2019 Dec 9.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Injectable Solution in people with Blood Loss, Surgical and Tranexamic Acid Adverse Reaction, run by Instituto Nacional de Traumatologia e Ortopedia at 1 site in Brazil.
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 1 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 9 Mar 2017. 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 Brazil. 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. Some participants in this study may receive a placebo. 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?
Hemoglobin drop (time frame: 24 hours post operative). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03019198, which also lists 1 linked publication.
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 9 Mar 2017.