Hemorrhage PostoperativePhase 4NCT04855877
Oral Administration of Tranexamic Acid in Anterior Cruciate Ligament Surgery Reduce Postoperative Haemarthrosis
A Phase 4 study testing Oral tablet in people with Hemorrhage Postoperative and Anterior Cruciate Ligament Rupture, run by University of Liege at 1 site in Belgium.
Trial summary
To find superiority relationship between oral and intravenous administration of tranexamic acid on peroperative and postoperative blood loss, haemarthrosis prevalence and improvement functional prognosis in anterior cruciate ligament arthroscopy. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hemorrhage Postoperative, Anterior Cruciate Ligament Rupture, Arthroscopy
- What is being tested?
- Oral tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteBelgium
- Study dates
- 6 Jul 2021to 1 Jul 2023
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary arthroscopic surgery for anterior cruciate ligament reconstruction
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.
Belgium1 site, 1 recruiting
- Recruiting
CHU de Liège
Liège, 4000
Michele Carella, MD, 003242843658
About this study
Official title: Does Oral Administration of Tranexamic Acid in Anterior Cruciate Ligament Arthroscopic Surgery Reduce Postoperative Haemarthrosis and Improve Functional Prognosis?
To find superiority relationship between oral and intravenous administration of tranexamic acid on peroperative and postoperative blood loss, haemarthrosis prevalence and improvement functional prognosis in anterior cruciate ligament arthroscopy.
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.
- Conditions
- Hemorrhage Postoperative, Anterior Cruciate Ligament Rupture, Arthroscopy, Total Blood Loss
- Being tested
- Oral tablet, Placebo
- Medical subject headings
- Postoperative Hemorrhage, Anterior Cruciate Ligament Injuries, Exsanguination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral tabletDrug
Oral administration of 2 grammes tranexamic acid 2 hours before skin incision and 2 grammes oral tranexamic acid 4 hours after first administration
PlaceboDrug
Oral administration of lactose tablet (placebo)
| Study group | Role | What they receive |
|---|---|---|
| Oral Tranexamic Acid | Active comparator | 52 patients scheduled for primary anteriori cruciate ligament surgery by arthroscopy Receives: Drug: Oral tablet |
| Placebo | Placebo comparator | 52 patients scheduled for primary anteriori cruciate ligament surgery by arthroscopy Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of haemarthrosis
Postoperative (drainage) blood loss
Measured: First 24 hours after surgery
Secondary outcomes (9)
Postoperative pain
Postoperative pain score on numeric ratio scale (NRS) from 0 (no pain) to 10 (worst pain)
Measured: 24 hours after surgery
Postoperative pain
Postoperative pain score on numeric rating scale (NRS) from 0 (no pain) to 10 (worst pain)
Measured: 72 hours after surgery
Postoperative pain
Postoperative pain score on numeric rating scale (NRS) from 0 (no pain) to 10 (worst pain)
Measured: 7 days after surgery
Postoperative pain
Postoperative pain score on numeric rating scale (NRS) from 0 (no pain) to 10 (worst pain)
Measured: 15 days after surgery
Clinical evaluation of functional recovery
Tegner activity score from 0 (no activity) to 10 (competitive sport)
Measured: 1 days after surgery
Clinical evaluation of functional recovery
Tegner activity score from 0 (no activity) to 10 (competitive sport)
Measured: 3 days after surgery
Clinical evaluation of functional recovery
Tegner activity score from 0 (no activity) to 10 (competitive sport)
Measured: 7 days after surgery
Clinical evaluation of functional recovery
Tegner activity score from 0 (no activity) to 10 (competitive sport)
Measured: 15 days after surgery
Length of hospital stay
Total days of hospitalization
Measured: First 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start6 Jul 2021
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Jul 2023 (estimated)
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
- Model description
- Double blinded prospective randomized controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 104 participants (estimated)
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
- NCT04855877
- Sponsor's protocol ID
- TRANEX-LCA
- Status last verified
- Jul 2021
- First submitted
- 20 Apr 2021
- Last updated
- 28 Jul 2021
- 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 30640647Muhunthan K, Balakumar S, Navaratnaraja TS, Premakrishna S, Arulkumaran S. Plasma Concentrations of Tranexamic Acid in Postpartum Women After Oral Administration. Obstet Gynecol. 2020 Apr;135(4):945-948. doi: 10.1097/AOG.0000000000003750.
PubMed 32168220Karaaslan F, Karaoglu S, Yurdakul E. Reducing Intra-articular Hemarthrosis After Arthroscopic Anterior Cruciate Ligament Reconstruction by the Administration of Intravenous Tranexamic Acid: A Prospective, Randomized Controlled Trial. Am J Sports Med. 2015 Nov;43(11):2720-6. doi: 10.1177/0363546515599629. Epub 2015 Sep 2.
PubMed 26337246
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Oral Administration of Tranexamic Acid in Anterior Cruciate Ligament Arthroscopic Surgery Reduce Postoperative Haemarthrosis and Improve Functional Prognosis?
- ClinicalTrials.gov ID
- NCT04855877
- Acronym / sponsor ID
- TRANEX-LCA
- Conditions
- Hemorrhage Postoperative, Anterior Cruciate Ligament Rupture, Arthroscopy, Total Blood Loss
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 6 Jul 2021 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 22 Apr 2021 (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 superiority relationship between oral and intravenous administration of tranexamic acid on peroperative and postoperative blood loss, haemarthrosis prevalence and improvement functional prognosis in anterior cruciate ligament arthroscopy.
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
- Model description
- Double blinded prospective randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Oral Tranexamic Acid | Active comparator | Drug: Oral tablet52 patients scheduled for primary anteriori cruciate ligament surgery by arthroscopy |
| Placebo | Placebo comparator | Drug: Placebo52 patients scheduled for primary anteriori cruciate ligament surgery by arthroscopy |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Primary arthroscopic surgery for anterior cruciate ligament reconstruction
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 |
|---|---|---|
| Oral tabletOral 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 |
| PlaceboOral administration of lactose tablet (placebo) | Drug | Placebo |
Primary outcome
Assessment of haemarthrosis
Time frame: First 24 hours after surgery
Postoperative (drainage) blood loss
9 secondary outcomes
Postoperative pain
Time frame: 24 hours after surgery
Postoperative pain
Time frame: 72 hours after surgery
Postoperative pain
Time frame: 7 days after surgery
Postoperative pain
Time frame: 15 days after surgery
Clinical evaluation of functional recovery
Time frame: 1 days after surgery
Clinical evaluation of functional recovery
Time frame: 3 days after surgery
Clinical evaluation of functional recovery
Time frame: 7 days after surgery
Clinical evaluation of functional recovery
Time frame: 15 days after surgery
Length of hospital stay
Time frame: First 30 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
- 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 32168220Muhunthan K, Balakumar S, Navaratnaraja TS, Premakrishna S, Arulkumaran S. Plasma Concentrations of Tranexamic Acid in Postpartum Women After Oral Administration. Obstet Gynecol. 2020 Apr;135(4):945-948. doi: 10.1097/AOG.0000000000003750.
- Background: PubMed 26337246Karaaslan F, Karaoglu S, Yurdakul E. Reducing Intra-articular Hemarthrosis After Arthroscopic Anterior Cruciate Ligament Reconstruction by the Administration of Intravenous Tranexamic Acid: A Prospective, Randomized Controlled Trial. Am J Sports Med. 2015 Nov;43(11):2720-6. doi: 10.1177/0363546515599629. Epub 2015 Sep 2.
- 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.
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 Oral tablet in people with Hemorrhage Postoperative and Anterior Cruciate Ligament Rupture, 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: status not confirmed, as of the sponsor's last update on 28 Jul 2021. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicolas Piette, MD (003242843824, piettenicolas@me.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of haemarthrosis (time frame: First 24 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 NCT04855877, 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 28 Jul 2021.