Tranexamic AcidNCT03573245
Tranexamic Acid in Major Orthopedic Surgery: Comparison of 3 Dosage Regimen
An observational study of Tranexamic Acid and Knee Osteoarthritis, run by CUF Santarém Hospital.
Trial summary
Tranexamic acid has been shown to be effective in reducing blood loss and transfusion in orthopedic surgery. It remains unknown the ideal therapeutic regimen. The goal of this study is to compare 3 dosage regimen of tranexamic acid in patients submitted to major orthopedic surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tranexamic Acid, Knee Osteoarthritis, Ankle Osteoarthritis
- What is being tested?
- Tranexamic Acid
- Type of treatment
- Injection or infusion
- How many people
- 210 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2018to 1 Apr 2019
- Phase
- Observational
- 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
Study population: • Patients of a median size private hospital in Portugal
Who may be able to join
- Age ≥ 18 anos
- Total ankle arthroplasty
- Total knee arthroplasty
- Weight >50 kilogram
Who cannot join
- Allergy and Hypersensitivity to tranexamic acid
- Thromboembolic events history
- Epilepsy
- Acute kidney injury, Glomerular Filtration Rate < 50 ml/min
- Coagulation disorders
- Surgical reintervention
- Blood transfusion refusal
Trial locations and contacts
No sites are listed yet.
About this study
Tranexamic acid has been shown to be effective in reducing blood loss and transfusion in orthopedic surgery. It remains unknown the ideal therapeutic regimen. The goal of this study is to compare 3 dosage regimen of tranexamic acid in patients submitted to major orthopedic surgery.
Read the detailed description
There is ongoing debate, however, around optimal perioperative tranexamic acid dosing, which varies widely.
A large number of studies comparing tranexamic acid to placebo, overall blood loss and transfusion requirements are both reduced by ≈30%. A well designed tranexamic acid trial will provide answers to the best regimen dosage for perioperative tranexamic acid use. It will benefit patients by reducing allogeneic transfusions and their associated risks and costs, thus adding value to the care delivered.
- Conditions
- Tranexamic Acid, Knee Osteoarthritis, Ankle Osteoarthritis, Bleeding
- Being tested
- Tranexamic Acid
- Medical subject headings
- Osteoarthritis, Knee, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
Tranexamic acid effect on perioperative bleeding in orthopedic surgery
| Study group | Role | What they receive |
|---|---|---|
| intra-op single dose | intra-operative single dose of tranexamic acid Receives: Drug: Tranexamic Acid | |
| intra-op dose and additional dose | intra-operative dose of tranexamic acid and additional dose 3 hours after Receives: Drug: Tranexamic Acid | |
| intra-op dose and perfusion | intra-operative dose of tranexamic acid followed by a continuous infusion during 6 hours. Receives: Drug: Tranexamic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative bleeding
perioperative blood loss measured in mililiters (mL)
Measured: postoperative day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2018
- Study start1 Jul 2018 (estimated)
- Primary completion1 Apr 2019 (estimated)
- Study completion1 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tranexamic AcidStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CUF Santarém Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angela Sa, CUF Santarém Hospital
- Investigators
- Angela Sa, MD, Principal investigator, CUF Santarem Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03573245
- Sponsor's protocol ID
- ATX (Tranexamic acid )
- Status last verified
- Jun 2018
- First submitted
- 7 Jun 2018
- Last updated
- 29 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tranexamic Acid in Major Orthopedic Surgery: Comparison of 3 Dosage Regimen
- ClinicalTrials.gov ID
- NCT03573245
- Acronym / sponsor ID
- ATX (Tranexamic acid )
- Conditions
- Tranexamic Acid, Knee Osteoarthritis, Ankle Osteoarthritis, Bleeding
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- CUF Santarém HospitalUniversity, hospital or other
- Study start
- 1 Jul 2018 (estimated)
- Primary completion
- 1 Apr 2019 (estimated)
- Study completion
- 1 Apr 2019 (estimated)
- First posted
- 29 Jun 2018 (actual)
- 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 has been shown to be effective in reducing blood loss and transfusion in orthopedic surgery. It remains unknown the ideal therapeutic regimen. The goal of this study is to compare 3 dosage regimen of tranexamic acid in patients submitted to major orthopedic surgery.
Detailed description
There is ongoing debate, however, around optimal perioperative tranexamic acid dosing, which varies widely.
A large number of studies comparing tranexamic acid to placebo, overall blood loss and transfusion requirements are both reduced by ≈30%. A well designed tranexamic acid trial will provide answers to the best regimen dosage for perioperative tranexamic acid use. It will benefit patients by reducing allogeneic transfusions and their associated risks and costs, thus adding value to the care delivered.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| intra-op single dose | – | Drug: Tranexamic Acidintra-operative single dose of tranexamic acid |
| intra-op dose and additional dose | – | Drug: Tranexamic Acidintra-operative dose of tranexamic acid and additional dose 3 hours after |
| intra-op dose and perfusion | – | Drug: Tranexamic Acidintra-operative dose of tranexamic acid followed by a continuous infusion during 6 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- • Patients of a median size private hospital in Portugal
Key inclusion criteria (4 listed)
- Age ≥ 18 anos
- Total ankle arthroplasty
- Total knee arthroplasty
- Weight >50 kilogram
Key exclusion criteria (7 listed)
- Allergy and Hypersensitivity to tranexamic acid
- Thromboembolic events history
- Epilepsy
- Acute kidney injury, Glomerular Filtration Rate < 50 ml/min
- Coagulation disorders
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 AcidTranexamic acid effect on perioperative bleeding in orthopedic surgery | Drug | intra-op dose and additional dose, intra-op dose and perfusion, intra-op single dose |
Primary outcome
Perioperative bleeding
Time frame: postoperative day 2
perioperative blood loss measured in mililiters (mL)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2018.
- 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.
Angela Sa, MD principal investigator
CUF Santarem Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Tranexamic Acid and Knee Osteoarthritis, run by CUF Santarém Hospital.
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 7 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 29 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Contact Angela Sa, MD (+351243240240, angela.sa@jmellosaude.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative bleeding (time frame: postoperative day 2). 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 29 Jun 2018.