Tranexamic AcidPeriop_TXANCT05783648
Do Anesthesiologists Follow Guidelines on Perioperative Use of Tranexamic Acid?
An observational study of Tranexamic Acid and Blood Loss, Surgical, run by Erasme University Hospital at 1 site in Belgium.
Trial summary
Tranexamic acid has been used to reduce bleeding and transfusion for years. Randomized studies showed its efficacity in orthopedic surgery, trauma and post-partum hemorrhage. Few data were available for other types of surgery and the safety profile of tranexamic use was nor clearly established. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tranexamic Acid, Blood Loss, Surgical, Blood Transfusion
- What is being tested?
- Use of tranexamic acid
- How many people
- 1,726 participants
- Where
- 1 siteBelgium
- Study dates
- 3 Jul 2023to 29 Aug 2023
- 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 undergoing inpatient surgery either between oct 1st 2021 and dec 31st 2021 or oct 1st 2022 and dec 31st 2022
Who may be able to join
- Patients undergoing surgery either between oct 1st 2021 and dec 31st 201 or oct 1st 2022 and dec 31st 2022
- noncardiac surgery
- expected to require at least one overnight hospital admission after surgery
- at risk of perioperative bleeding
Who cannot join
- cardiac surgery
- intracranial neurosurgery
- creatinine clearance < 30 mL/min (Cockcroft-Gault equation)
- chronic dialysis
- history of seizure disorder
- recent (< 3 months) stroke, myocardial infarction, acute arterial thrombosis, venous thromboembolism
Show all 9Show fewer
- fibrinolytic condition following consumption coagulopathy
- subarachnoid hemorrhage within 30 days before surgery
- women of childbearing potential who are not taking effective contraception, pregnant or breast-feeding
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Hôpital Universitaire de Bruxelles - Hôpital erasme
Brussels, 1070
About this study
Tranexamic acid has been used to reduce bleeding and transfusion for years. Randomized studies showed its efficacity in orthopedic surgery, trauma and post-partum hemorrhage. Few data were available for other types of surgery and the safety profile of tranexamic use was nor clearly established. In april 2022, the results from the POISE-3 (Perioperative Ischemic Evaluation - 3) trial was published in the New England Journal of Medicine. This stdy clearly demonstrated in 9535 patients undergoing non-cardiac surgery, that the use of tranexamic acid significantly reduced not only perioperative bleeding, but also transfusions. The safety profile of tranexamic acid was very good in this trial. This publication was rapidly followed by editorials in major anesthesia journals, calling for "safe surgery" with a systematic use of tranexamic acid in the population studied in the POISE-3 trial. A literature review was done with a formal presentation at Erasme University Hospital, again with the call for a systematic use in appropriate patients.
In this study, the adherence to these recommendations will be tested. All patients operated between october 1st 2022 and december 31 st 2022 will be included. For every patient, it will be determined if this patient should have received tranexamic acid according to the results of the POISE-3 trial and wether this patient really did get tranexamic acid. Primary endpoint will be the percentage (%) of patients correctly treated according to the POISE-3 recommendations. A second primary endpoint will be the comparison with patients operated between October 1st 2021 and december 31st 2021; that means before the publication of the recommendations. The difference between both populations will be tested with a Chi-square test. Secondary outcomes wil be bleeding and transfusion in the correctly treated population compared with an eventually not correctly treated population.
- Conditions
- Tranexamic Acid, Blood Loss, Surgical, Blood Transfusion
- Being tested
- Use of tranexamic acid
- Medical subject headings
- Blood Loss, Surgical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of tranexamic acidDrug
Percentage of correct use according to POISE-3 criteria of tranexamic acid
| Study group | Role | What they receive |
|---|---|---|
| Before TXA recommendations | All patients operated between october 1st, 2021 and december 31st 2021, that means before the publication of the POISE-3 trial and the recommendations on the use of tranexamic acid. Receives: Drug: Use of tranexamic acid | |
| After TXA recommendations | All patients operated between october 1st, 2022 and december 31st 2022, that means after the publication of the POISE-3 trial and the recommendations on the use of tranexamic acid. Receives: Drug: Use of tranexamic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of correct use of TXA
Percentage of patients who received tranexamic acid correctly according to the POISE-3 criteria
Measured: 12 hours
Comparison of percentage use of TXA before and after the release of TXA recommendations
The use of tranexamic acid (in percentage) will be compared between the two cohorts, before and after the publication of the recommendations on the use of tranexamic acid
Measured: 12 hours
Secondary outcomes (2)
Blood loss
Comparison of blood loss between correctly treated patients and not correctly treated patients according to the POISE-3 criteria
Measured: 24 hours
Transfusion
Comparison of blood transfusion between correctly treated patients and not correctly treated patients according to the POISE-3 criteria
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2023
- Study start3 Jul 2023
- Primary completion25 Aug 2023
- Study completion29 Aug 2023
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
- Retrospective
- Enrolment
- 1,726 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05783648
- Sponsor's protocol ID
- SRB2023055
- Acronym
- Periop_TXA
- Status last verified
- Mar 2023
- First submitted
- 13 Mar 2023
- Last updated
- 30 Aug 2023
- 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 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Anesthesiologists Follow Guidelines on Perioperative Use of Tranexamic Acid?
- ClinicalTrials.gov ID
- NCT05783648
- Acronym / sponsor ID
- Periop_TXA / SRB2023055
- Conditions
- Tranexamic Acid, Blood Loss, Surgical, Blood Transfusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,726 participants (actual)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Study start
- 3 Jul 2023 (actual)
- Primary completion
- 25 Aug 2023 (actual)
- Study completion
- 29 Aug 2023 (actual)
- First posted
- 24 Mar 2023 (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 used to reduce bleeding and transfusion for years. Randomized studies showed its efficacity in orthopedic surgery, trauma and post-partum hemorrhage. Few data were available for other types of surgery and the safety profile of tranexamic use was nor clearly established. In april 2022, the results from the POISE-3 (Perioperative Ischemic Evaluation - 3) trial was published in the New England Journal of Medicine. This stdy clearly demonstrated in 9535 patients undergoing non-cardiac surgery, that the use of tranexamic acid significantly reduced not only perioperative bleeding, but also transfusions. The safety profile of tranexamic acid was very good in this trial. This publication was rapidly followed by editorials in major anesthesia journals, calling for "safe surgery" with a systematic use of tranexamic acid in the population studied in the POISE-3 trial. A literature review was done with a formal presentation at Erasme University Hospital, again with the call for a systematic use in appropriate patients.
In this study, the adherence to these recommendations will be tested. All patients operated between october 1st 2022 and december 31 st 2022 will be included. For every patient, it will be determined if this patient should have received tranexamic acid according to the results of the POISE-3 trial and wether this patient really did get tranexamic acid. Primary endpoint will be the percentage (%) of patients correctly treated according to the POISE-3 recommendations. A second primary endpoint will be the comparison with patients operated between October 1st 2021 and december 31st 2021; that means before the publication of the recommendations. The difference between both populations will be tested with a Chi-square test. Secondary outcomes wil be bleeding and transfusion in the correctly treated population compared with an eventually not correctly treated population.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Before TXA recommendations | – | Drug: Use of tranexamic acidAll patients operated between october 1st, 2021 and december 31st 2021, that means before the publication of the POISE-3 trial and the recommendations on the use of tranexamic acid. |
| After TXA recommendations | – | Drug: Use of tranexamic acidAll patients operated between october 1st, 2022 and december 31st 2022, that means after the publication of the POISE-3 trial and the recommendations on the use of tranexamic acid. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing inpatient surgery either between oct 1st 2021 and dec 31st 2021 or oct 1st 2022 and dec 31st 2022
Key inclusion criteria (4 listed)
- Patients undergoing surgery either between oct 1st 2021 and dec 31st 201 or oct 1st 2022 and dec 31st 2022
- noncardiac surgery
- expected to require at least one overnight hospital admission after surgery
- at risk of perioperative bleeding
Key exclusion criteria (9 listed)
- cardiac surgery
- intracranial neurosurgery
- creatinine clearance < 30 mL/min (Cockcroft-Gault equation)
- chronic dialysis
- history of seizure disorder
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 |
|---|---|---|
| Use of tranexamic acidPercentage of correct use according to POISE-3 criteria of tranexamic acid | Drug | After TXA recommendations, Before TXA recommendations |
Primary outcome
Percentage of correct use of TXA
Time frame: 12 hours
Percentage of patients who received tranexamic acid correctly according to the POISE-3 criteria
Comparison of percentage use of TXA before and after the release of TXA recommendations
Time frame: 12 hours
The use of tranexamic acid (in percentage) will be compared between the two cohorts, before and after the publication of the recommendations on the use of tranexamic acid
2 secondary outcomes
Blood loss
Time frame: 24 hours
Transfusion
Time frame: 24 hours
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 30 Aug 2023.
- 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?
An observational study of Tranexamic Acid and Blood Loss, Surgical, run by Erasme University Hospital at 1 site in Belgium.
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 9 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 30 Aug 2023. 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 Belgium. 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.
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?
Percentage of correct use of TXA (time frame: 12 hours). The study lists 2 primary outcomes in all. 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 30 Aug 2023.