Arthropathy of HipPhase 2PRADONCT03822793
A Dose-response Study of Tranexamic Acid in Total Hip Arthroplasty
A Phase 2 study testing Group 1: perfusion of 300 mg Exacyl, Group 2: perfusion of 500 mg Exacyl and Group 3: perfusion of 1000 mg Exacyl in people with Arthropathy of Hip, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
A single preoperative dose of tranexamic acid (TXA) reduces blood loss and red blood cell transfusion in primary hip arthroplasty. Numerous regimens have been tested, ranging from 10mg/kg up to 3g. However the optimal dose to administer is unknown. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthropathy of Hip
- What is being tested?
- Group 1: perfusion of 300 mg Exacyl, Group 2: perfusion of 500 mg Exacyl and Group 3: perfusion of 1000 mg Exacyl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 170 participants
- Where
- 1 siteFrance
- Study dates
- 7 Dec 2023to 11 Jul 2025
- Phase
- Phase 2
- 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
Who may be able to join
- Patient requiring primary hip arthroplasty (less than 3 months)
- Informed Consent from the patient or their legally authorized representative
- Affiliation to French Social Security Healthcare system
Who cannot join
- Hip fracture of less than 3 months
- Bilateral hip arthroplasty or anterior approach to hip arthroplasty
- Haemorrhagic surgery in the previous 2 weeks
- Contraindication to tranexamic acid
- Contraindication to apixaban
- Chronic use of anticoagulant
- Pregnancy
- Previous participation to this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dose Study of Tranexamic Acid in Total Hip Replacement to Reduce Post-operative Hemoglobin Loss: A Phase 2 Randomized Double-blind Monocentric Study
A single preoperative dose of tranexamic acid (TXA) reduces blood loss and red blood cell transfusion in primary hip arthroplasty. Numerous regimens have been tested, ranging from 10mg/kg up to 3g. However the optimal dose to administer is unknown.
Read the detailed description
This dose-response study is a randomized double blind study with five groups of 30 patients each. Patients will be randomized to placebo, tranexamic acid (TXA) 300 mg, tranexamic acid (TXA) 500 mg, tranexamic acid (TXA) 1000 mg or tranexamic acid (TXA) 3000 mg. In addition a pharmacokinetic/pharmacodynamic study will be performed to identify the contribution of tranexamic acid (TXA) plasma concentration as a predictor of intra and postoperative D-Dimer values.
- Conditions
- Arthropathy of Hip
- Being tested
- Placebo, Group 1: perfusion of 300 mg Exacyl, Group 2: perfusion of 500 mg Exacyl, Group 3: perfusion of 1000 mg Exacyl, Group 4: perfusion of 3000 mg Exacyl
- Keywords
- tranexamic acid (TXA), arthroplasty, hip, Exacyl
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Patient will receive an intravenous perfusion of NaCl (sodium chloride 9%; placebo) intravenous over 9 minutes, starting at the time of surgical incision.
Group 1: perfusion of 300 mg ExacylDrug
Patient will receive an intravenous perfusion of 300 mg Exacyl (tranexamic acid) intravenous (IV) over 9 minutes, starting at the time of surgical incision.
Group 2: perfusion of 500 mg ExacylDrug
Patient will receive an intravenous perfusion of 500 mg Exacyl (tranexamic acid) intravenous (IV) over 9 minutes, starting at the time of surgical incision.
Group 3: perfusion of 1000 mg ExacylDrug
Patient will receive an intravenous perfusion of 1000 mg Exacyl (tranexamic acid) intravenous (IV) over 9 minutes, starting at the time of surgical incision.
Group 4: perfusion of 3000 mg ExacylDrug
Patient will receive an intravenous perfusion of 3000 mg Exacyl (tranexamic acid) intravenous (IV) over 9 minutes, starting at the time of surgical incision.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Patient will be included in this group by randomization and they will receive an intravenous perfusion of NaCl (sodium chloride 9%; placebo) intravenous over 9 minutes, starting at the time of surgical incision. Receives: Drug: Placebo |
| Group 1: perfusion of 300 mg Exacyl | Experimental | Patient will be included in the group 2 by randomization and they will receive an intravenous perfusion of 300 mg Exacyl (tranexamic acid) intravenous (IV) over 9 minutes, starting at the time of surgical incision. Receives: Drug: Group 1: perfusion of 300 mg Exacyl |
| Group 2: perfusion of 500 mg Exacyl | Experimental | Patient will be included in the group 2 by randomization and they will receive an intravenous perfusion of 500 mg Exacyl (tranexamic acid) intravenous (IV) over 9 minutes, starting at the time of surgical incision.. Receives: Drug: Group 2: perfusion of 500 mg Exacyl |
| Group 3: perfusion of 1000 mg Exacyl | Experimental | Patient will be included in the group 3 by randomization and they will receive an intravenous perfusion of 1000 mg Exacyl (tranexamic acid) intravenous (IV) over 9 minutes, starting at the time of surgical incision. Receives: Drug: Group 3: perfusion of 1000 mg Exacyl |
| Group 4: perfusion of 3000 mg Exacyl | Experimental | Patient will be included in the group 4 by randomization and they will receive an intravenous perfusion of 3000 mg Exacyl (tranexamic acid) intravenous (IV) over 9 minutes, starting at the time of surgical incision. Receives: Drug: Group 4: perfusion of 3000 mg Exacyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
haemoglobin decrease in the perioperative period
Percentage of haemoglobin change in the perioperative period. It requires the sampling of haemoglobin just before surgery (Day 1) and on the fourth postoperative day
Measured: Day 1 to Day 4
Secondary outcomes (7)
Tranexamic acid pharmacokinetics
For tranexamic acid pharmacokinetics, the outcome measure is the sampling of tranexamic blood concentration.
Measured: Day 1
D-Dimer kinetics
For tranexamic acid pharmacodynamics, the outcome is the sampling of D-Dimer levels.
Measured: Day 1
allogenic red blood cell transfusion
For allogenic red blood cell transfusion, the outcome measure will be the percentage of patients that will receive the transfusion of at least one allogenic red blood cell unit in the perioperative period.
Measured: Day 1 to day 8
severe anaemia
For severe anaemia (defined as a level of haemoglobin <10 gram by deciliter), the outcome measure will be the percentage of patients that will have at least one value of haemoglobin <10 gram by deciliter in the perioperative period.
Measured: Day 1 to day 8
incidence of symptomatic thrombotic events and death
For the incidence of symptomatic thrombotic events and death, the outcome measure is a combined criteria of venous events (deep venous thrombosis or pulmonary embolism), arterial events (acute coronary syndrome, stroke or peripheral arterial thrombosis) and death.
Measured: Day 1 to day 8
occurrence of a seizure
The endpoint is a combined criteria endpoint involving either the clinical observation of a generalized tonic-clonic seizure or a partial seizure or an epilepsy confirmed by an electroencephalogram interpreted by a neurologist blinded to the patient's inclusion group.
Measured: Day 8
number of adverse events
collection in medical records the adverse events at 45 days after surgery :
- venous thrombo-embolism / arterial
- hematoma leading to modification of rehabilitation or requiring revision surgery
- infections of superficial or deep surgical site
Measured: Day: 45
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start7 Dec 2023
- Primary completion21 Apr 2025
- Study completion11 Jul 2025
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 Arthropathy of HipStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julien LANOISELEE, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03822793
- Sponsor's protocol ID
- 18CH052
- Other IDs
- 2018-004552-37, 2022-502532-38-01, 2018
- Acronym
- PRADO
- Status last verified
- Nov 2025
- First submitted
- 31 Dec 2018
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zufferey PJ, Barrat E, Deygas B, Lanoiselee J, Ollier E. Dose-effect relationship of intravenous tranexamic acid on perioperative haemoglobin drop in total hip arthroplasty (PRADO study): study protocol for a randomised, double-blind, placebo-controlled, dose-response study. BMJ Open. 2025 Dec 3;15(12):e100265. doi: 10.1136/bmjopen-2025-100265.
PubMed 41338640
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Study of Tranexamic Acid in Total Hip Replacement to Reduce Post-operative Hemoglobin Loss: A Phase 2 Randomized Double-blind Monocentric Study
- ClinicalTrials.gov ID
- NCT03822793
- Acronym / sponsor ID
- PRADO / 18CH052
- Conditions
- Arthropathy of Hip
- Keywords
- tranexamic acid (TXA), arthroplasty, hip, Exacyl
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 7 Dec 2023 (actual)
- Primary completion
- 21 Apr 2025 (actual)
- Study completion
- 11 Jul 2025 (actual)
- First posted
- 30 Jan 2019 (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.
A single preoperative dose of tranexamic acid (TXA) reduces blood loss and red blood cell transfusion in primary hip arthroplasty. Numerous regimens have been tested, ranging from 10mg/kg up to 3g. However the optimal dose to administer is unknown.
Detailed description
This dose-response study is a randomized double blind study with five groups of 30 patients each. Patients will be randomized to placebo, tranexamic acid (TXA) 300 mg, tranexamic acid (TXA) 500 mg, tranexamic acid (TXA) 1000 mg or tranexamic acid (TXA) 3000 mg. In addition a pharmacokinetic/pharmacodynamic study will be performed to identify the contribution of tranexamic acid (TXA) plasma concentration as a predictor of intra and postoperative D-Dimer values.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPatient will be included in this group by randomization and they will receive an intravenous perfusion of NaCl (sodium chloride 9%; placebo) intravenous over 9 minutes, starting at the time of surgical incision. |
| Group 1: perfusion of 300 mg Exacyl | Experimental | Drug: Group 1: perfusion of 300 mg ExacylPatient will be included in the group 2 by randomization and they will receive an intravenous perfusion of 300 mg Exacyl (tranexamic acid) intravenous (IV) over 9 minutes, starting at the time of surgical incision. |
| Group 2: perfusion of 500 mg Exacyl | Experimental | Drug: Group 2: perfusion of 500 mg ExacylPatient will be included in the group 2 by randomization and they will receive an intravenous perfusion of 500 mg Exacyl (tranexamic acid) intravenous (IV) over 9 minutes, starting at the time of surgical incision.. |
| Group 3: perfusion of 1000 mg Exacyl | Experimental | Drug: Group 3: perfusion of 1000 mg ExacylPatient will be included in the group 3 by randomization and they will receive an intravenous perfusion of 1000 mg Exacyl (tranexamic acid) intravenous (IV) over 9 minutes, starting at the time of surgical incision. |
| Group 4: perfusion of 3000 mg Exacyl | Experimental | Drug: Group 4: perfusion of 3000 mg ExacylPatient will be included in the group 4 by randomization and they will receive an intravenous perfusion of 3000 mg Exacyl (tranexamic acid) intravenous (IV) over 9 minutes, starting at the time of surgical incision. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient requiring primary hip arthroplasty (less than 3 months)
- Informed Consent from the patient or their legally authorized representative
- Affiliation to French Social Security Healthcare system
Key exclusion criteria (8 listed)
- Hip fracture of less than 3 months
- Bilateral hip arthroplasty or anterior approach to hip arthroplasty
- Haemorrhagic surgery in the previous 2 weeks
- Contraindication to tranexamic acid
- Contraindication to apixaban
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 |
|---|---|---|
| PlaceboPatient will receive an intravenous perfusion of NaCl (sodium chloride 9%; placebo) intravenous over 9 minutes, starting at the time of surgical incision. | Drug | Placebo |
| Group 1: perfusion of 300 mg ExacylPatient will receive an intravenous perfusion of 300 mg Exacyl (tranexamic acid) intravenous (IV) over 9 minutes, starting at the time of surgical incision. | Drug | Group 1: perfusion of 300 mg Exacyl |
| Group 2: perfusion of 500 mg ExacylPatient will receive an intravenous perfusion of 500 mg Exacyl (tranexamic acid) intravenous (IV) over 9 minutes, starting at the time of surgical incision. | Drug | Group 2: perfusion of 500 mg Exacyl |
| Group 3: perfusion of 1000 mg ExacylPatient will receive an intravenous perfusion of 1000 mg Exacyl (tranexamic acid) intravenous (IV) over 9 minutes, starting at the time of surgical incision. | Drug | Group 3: perfusion of 1000 mg Exacyl |
| Group 4: perfusion of 3000 mg ExacylPatient will receive an intravenous perfusion of 3000 mg Exacyl (tranexamic acid) intravenous (IV) over 9 minutes, starting at the time of surgical incision. | Drug | Group 4: perfusion of 3000 mg Exacyl |
Primary outcome
haemoglobin decrease in the perioperative period
Time frame: Day 1 to Day 4
Percentage of haemoglobin change in the perioperative period. It requires the sampling of haemoglobin just before surgery (Day 1) and on the fourth postoperative day
7 secondary outcomes
Tranexamic acid pharmacokinetics
Time frame: Day 1
D-Dimer kinetics
Time frame: Day 1
allogenic red blood cell transfusion
Time frame: Day 1 to day 8
severe anaemia
Time frame: Day 1 to day 8
incidence of symptomatic thrombotic events and death
Time frame: Day 1 to day 8
occurrence of a seizure
Time frame: Day 8
number of adverse events
Time frame: Day: 45
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 26 Nov 2025.
- Derived from this study: PubMed 41338640Zufferey PJ, Barrat E, Deygas B, Lanoiselee J, Ollier E. Dose-effect relationship of intravenous tranexamic acid on perioperative haemoglobin drop in total hip arthroplasty (PRADO study): study protocol for a randomised, double-blind, placebo-controlled, dose-response study. BMJ Open. 2025 Dec 3;15(12):e100265. doi: 10.1136/bmjopen-2025-100265.
- 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.
Julien LANOISELEE, MD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Group 1: perfusion of 300 mg Exacyl, Group 2: perfusion of 500 mg Exacyl and Group 3: perfusion of 1000 mg Exacyl in people with Arthropathy of Hip, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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 3 inclusion and 8 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 26 Nov 2025. 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 France. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
haemoglobin decrease in the perioperative period (time frame: Day 1 to Day 4). 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 NCT03822793, 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 26 Nov 2025.