Hemorrhage PostoperativePhase 4NCT04691362
Noninferiority Oral Tranexamic Acid vs Intravenous Administration in Total Hip Arthroplasty
A Phase 4 study testing Tranexamic Acid Oral Product and Tranexamic acid injection in people with Hemorrhage Postoperative and Total Blood Loss, run by University of Liege at 1 site in Belgium.
Trial summary
To find noninferiority relationship between oral and intravenous administration of tranexamic acid on peroperative and postoperative blood loss and serum concentration during primary total hip arthroplasty. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hemorrhage Postoperative, Total Blood Loss, Arthroplasty Complications
- What is being tested?
- Tranexamic Acid Oral Product and Tranexamic acid injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jan 2021to 14 Dec 2022
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA physical status 1, 2 and 3 scheduled for primary total hip arthroplasty
Who cannot join
- Renal failure with serum creatinine level higher than 1,40 mg/dL
- Thromboembolic events in last 12 months before surgery
- Pregnancy
- Congenital or acquired coagulation diseases
- History of gastric surgery that could lead to malabsorption
- Diabetic gastro-paresis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Noninferiority of an Oral vs Intravenous Administration of Tranexamic Acid in Total Hip Arthroplasty
To find noninferiority relationship between oral and intravenous administration of tranexamic acid on peroperative and postoperative blood loss and serum concentration during primary total hip arthroplasty.
Read the detailed description
Tranexamic acid is an anti-fibrinolytic drug, recommended in total hip arthroplasty to reduce peroperative and postoperative hemorrhagic complications. The original character of our study lies in the serum dosage of tranexamic acid, allowing to correlate the primary objective (blood loss) with this one. The investigators will focus on the reduction of the risks associated with the administration of intravenous medicines, the economic aspect and the ease of use.
- Being tested
- Tranexamic Acid Oral Product, Tranexamic acid injection
- Medical subject headings
- Postoperative Hemorrhage, Exsanguination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic Acid Oral ProductDrug
Oral administration of 2 grammes tranexamic acid 2 hours before skin incision and 2 grammes oral tranexamic acid 4 hours after first administration
Tranexamic acid injectionDrug
Intravenous administration of 1 gramme tranexamic acid 30 minutes before skin incision and 1 gramme intravenous tranexamic acid 4 hours after first administration
| Study group | Role | What they receive |
|---|---|---|
| Oral Tranexamic Acid | Active comparator | 128 patients scheduled for primary total hip arthroplasty Receives: Drug: Tranexamic Acid Oral Product |
| Intravenous Tranexamic Acid | Active comparator | 128 patients scheduled for primary total hip arthroplasty Receives: Drug: Tranexamic acid injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total blood loss
Peroperative (suction) and postoperative (drainage) total blood loss
Measured: First 48 hours after surgery
Secondary outcomes (9)
Serum concentration of tranexamic acid
Monitoring of serum dosage of tranxemaic acid in randomized subpopulation of each group
Measured: 2 hours after oral administration
Serum concentration of tranexamic acid
Monitoring of serum dosage of tranxemaic acid in randomized subpopulation of each group
Measured: 6 hours after oral administration
Serum concentration of tranexamic acid
Monitoring of serum dosage of tranxemaic acid in randomized subpopulation of each group
Measured: 30 minutes after intravenous administration
Serum concentration of tranexamic acid
Monitoring of serum dosage of tranxemaic acid in randomized subpopulation of each group
Measured: 4 hours after intravenous administration
Serum hemoglobin variation
Variation of serum hemoglobin between preoperative and postoperative period
Measured: 24 hours after surgery
Serum hemoglobin variation
Variation of serum hemoglobin between preoperative and postoperative period
Measured: 72 hours after surgery
Incidence of blood transfusion
Incidence of blood transfusion in two groups
Measured: 72 hours after surgery
Incidence of thromboembolic complications
Incidence of thromboembolic complications such as pulmonary embolism or deep venous thrombosis
Measured: 72 hours after surgery
Length of hospitalisation stay
Difference between two groups of total hospitalisation days
Measured: 1 week after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start1 Jan 2021
- Primary completion14 Dec 2022
- Study completion14 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hemorrhage PostoperativeStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean François Brichant, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04691362
- Sponsor's protocol ID
- 2020-316
- Status last verified
- Dec 2022
- First submitted
- 29 Dec 2020
- Last updated
- 15 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fillingham YA, Ramkumar DB, Jevsevar DS, Yates AJ, Bini SA, Clarke HD, Schemitsch E, Johnson RL, Memtsoudis SG, Sayeed SA, Sah AP, Della Valle CJ. Tranexamic acid in total joint arthroplasty: the endorsed clinical practice guides of the American Association of Hip and Knee Surgeons, American Society of Regional Anesthesia and Pain Medicine, American Academy of Orthopaedic Surgeons, Hip Society, and Knee Society. Reg Anesth Pain Med. 2019 Jan;44(1):7-11. doi: 10.1136/rapm-2018-000024. No abstract available.
PubMed 30640647Wu Y, Zeng Y, Hu Q, Li M, Bao X, Zhong J, Shen B. Blood loss and cost-effectiveness of oral vs intravenous tranexamic acid in primary total hip arthroplasty: A randomized clinical trial. Thromb Res. 2018 Nov;171:143-148. doi: 10.1016/j.thromres.2018.10.006. Epub 2018 Oct 6.
PubMed 30312799Piette N, Beck F, Carella M, Hans G, Maesen D, Kurth W, Lecoq JP, Bonhomme VL. Oral as compared to intravenous tranexamic acid to limit peri-operative blood loss associated with primary total hip arthroplasty: A randomised noninferiority trial. Eur J Anaesthesiol. 2024 Mar 1;41(3):217-225. doi: 10.1097/EJA.0000000000001950. Epub 2024 Jan 12.
PubMed 38214552
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Noninferiority of an Oral vs Intravenous Administration of Tranexamic Acid in Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT04691362
- Acronym / sponsor ID
- 2020-316
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 14 Dec 2022 (actual)
- Study completion
- 14 Dec 2022 (actual)
- First posted
- 31 Dec 2020 (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.
To find noninferiority relationship between oral and intravenous administration of tranexamic acid on peroperative and postoperative blood loss and serum concentration during primary total hip arthroplasty.
Detailed description
Tranexamic acid is an anti-fibrinolytic drug, recommended in total hip arthroplasty to reduce peroperative and postoperative hemorrhagic complications. The original character of our study lies in the serum dosage of tranexamic acid, allowing to correlate the primary objective (blood loss) with this one. The investigators will focus on the reduction of the risks associated with the administration of intravenous medicines, the economic aspect and the ease of use.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Tranexamic Acid | Active comparator | Drug: Tranexamic Acid Oral Product128 patients scheduled for primary total hip arthroplasty |
| Intravenous Tranexamic Acid | Active comparator | Drug: Tranexamic acid injection128 patients scheduled for primary total hip arthroplasty |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA physical status 1, 2 and 3 scheduled for primary total hip arthroplasty
Key exclusion criteria (6 listed)
- Renal failure with serum creatinine level higher than 1,40 mg/dL
- Thromboembolic events in last 12 months before surgery
- Pregnancy
- Congenital or acquired coagulation diseases
- History of gastric surgery that could lead to malabsorption
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 ProductOral administration of 2 grammes tranexamic acid 2 hours before skin incision and 2 grammes oral tranexamic acid 4 hours after first administration | Drug | Oral Tranexamic Acid |
| Tranexamic acid injectionIntravenous administration of 1 gramme tranexamic acid 30 minutes before skin incision and 1 gramme intravenous tranexamic acid 4 hours after first administration | Drug | Intravenous Tranexamic Acid |
Primary outcome
Total blood loss
Time frame: First 48 hours after surgery
Peroperative (suction) and postoperative (drainage) total blood loss
9 secondary outcomes
Serum concentration of tranexamic acid
Time frame: 2 hours after oral administration
Serum concentration of tranexamic acid
Time frame: 6 hours after oral administration
Serum concentration of tranexamic acid
Time frame: 30 minutes after intravenous administration
Serum concentration of tranexamic acid
Time frame: 4 hours after intravenous administration
Serum hemoglobin variation
Time frame: 24 hours after surgery
Serum hemoglobin variation
Time frame: 72 hours after surgery
Incidence of blood transfusion
Time frame: 72 hours after surgery
Incidence of thromboembolic complications
Time frame: 72 hours after surgery
Length of hospitalisation stay
Time frame: 1 week after surgery
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 15 Dec 2022.
- Background: PubMed 30640647Fillingham YA, Ramkumar DB, Jevsevar DS, Yates AJ, Bini SA, Clarke HD, Schemitsch E, Johnson RL, Memtsoudis SG, Sayeed SA, Sah AP, Della Valle CJ. Tranexamic acid in total joint arthroplasty: the endorsed clinical practice guides of the American Association of Hip and Knee Surgeons, American Society of Regional Anesthesia and Pain Medicine, American Academy of Orthopaedic Surgeons, Hip Society, and Knee Society. Reg Anesth Pain Med. 2019 Jan;44(1):7-11. doi: 10.1136/rapm-2018-000024. No abstract available.
- Background: PubMed 30312799Wu Y, Zeng Y, Hu Q, Li M, Bao X, Zhong J, Shen B. Blood loss and cost-effectiveness of oral vs intravenous tranexamic acid in primary total hip arthroplasty: A randomized clinical trial. Thromb Res. 2018 Nov;171:143-148. doi: 10.1016/j.thromres.2018.10.006. Epub 2018 Oct 6.
- Derived from this study: PubMed 38214552Piette N, Beck F, Carella M, Hans G, Maesen D, Kurth W, Lecoq JP, Bonhomme VL. Oral as compared to intravenous tranexamic acid to limit peri-operative blood loss associated with primary total hip arthroplasty: A randomised noninferiority trial. Eur J Anaesthesiol. 2024 Mar 1;41(3):217-225. doi: 10.1097/EJA.0000000000001950. Epub 2024 Jan 12.
- 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 Oral Product and Tranexamic acid injection in people with Hemorrhage Postoperative and Total Blood Loss, run by University of Liege 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 1 inclusion and 6 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 15 Dec 2022. 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.
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?
Total blood loss (time frame: First 48 hours after surgery). 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 NCT04691362, which also lists 3 linked publications.
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 15 Dec 2022.