Blood Loss After a Total Hip ReplacementPhase 3ESPERNCT02403596
Blood-sparing During Hip Prosthesis Surgery With Exacyl® in Patients Treated With Rivaroxaban
A Phase 3 study testing Exacyl® in people with Blood Loss After a Total Hip Replacement, run by University Hospital, Brest at 4 sites in France.
Trial summary
This study evaluates the efficacy of tranexamic acid versus placebo on perioperative blood loss using two dosage regimens (standard and extended) after a surgery during total hip arthroplasty in patients receiving the novel fast-acting oral anticoagulant rivaroxaban for prophylaxis of thrombosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Loss After a Total Hip Replacement
- What is being tested?
- Exacyl®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 231 participants
- Where
- 4 sitesFrance
- Study dates
- 20 Oct 2015to 29 Aug 2017
- Phase
- Phase 3
- 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
- Over 18 years of age
- Scheduled to undergo elective non-traumatic primary cementless THA
- Having given written informed consent to participate in the trial
- Covered by Social Security
Who cannot join
- Rapidly destructive arthrosis of the hip
- History of prior surgery on the operative hip
- Contraindications to the use of tranexamic acid:
- Ischaemic artery disease (angina pectoris, myocardial infarction, acute coronary syndrome or stroke)
- History of venous thromboembolism
- Severe renal impairment, i.e. with clearance < 30mL/mn
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- Epilepsy or history of convulsions
- Contraindications to the use of rivaroxaban
- Severe renal failure (clearance <30ml / min)
- Cirrhotic patients with Child Pugh B
- Pregnancy and breastfeeding
- Cognitive disorder that precludes giving informed consent
- Refusal to participate in trial
- Allergy to either of the trial treatments
- On-going prophylaxis of thrombosis using an agent other than rivaroxaban
- On-going platelet aggregation inhibitor at a dose exceeding 125 mg daily
Trial locations and contacts
4 sites in 1 country.
France4 sites
HIA Clermont Tonnerre Brest
Brest, 29200
Polyclinique de Keraudren
Brest, 29287
CHRU Brest
Brest, 29609
CH Morlaix
Morlaix, 29672
About this study
Official title: Study ESPER: Blood-sparing During the Placement of a Total Hip Prosthesis With the Exacyl® in Patients Treated With Rivaroxaban, Phase IV
This study evaluates the efficacy of tranexamic acid versus placebo on perioperative blood loss using two dosage regimens (standard and extended) after a surgery during total hip arthroplasty in patients receiving the novel fast-acting oral anticoagulant rivaroxaban for prophylaxis of thrombosis.
Read the detailed description
In 2011, 140 000 total hip replacements were performed and bleeding remains one of the major complications responsible for significant morbidity. This study will evaluate a new treatment to prevent bleeding due to this surgery. Indeed, the tranexamic acid (Exacyl) will be used in two modes of administration (standard or extended) versus placebo combined with a Rivaroxaban treatment at a dose of 10 mg / day for 35 days.
Patients will be randomized (exacyl standard vs exacyl extended vs. placebo) and will be followed for 3 months.
- Conditions
- Blood Loss After a Total Hip Replacement
- Being tested
- Exacyl®, Placebo of Exacyl®
- Keywords
- Hip replacement, rivaroxaban, exacyl, blood loss
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exacyl®Drug
Also called Tranexamic acid
Placebo of Exacyl®Other
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Exacyl®: Standard treatment | Experimental | Intravenous use. 1g Exacyl® at H0 (Hour = 0 in other term at the time of incision) then 1g Exacyl® at H+3 then 1g Exacyl® placebo at H+7 and H+11 Receives: Drug: Exacyl®; Other: Placebo of Exacyl® |
| Group 2: Exacyl®: Extended treatment | Experimental | Intravenous use. 1g Exacyl® at H0 (Hour = 0 in other term at the time of incision) then 1g Exacyl® at H+3 / H+7 and H+11 Receives: Drug: Exacyl® |
| Group 3: Placebo | Placebo comparator | This group will receive a placebo of Exacyl®: 1g placebo of Exacyl® at H0 (Hour = 0 in other term at the time of incision) then 1g placebo of Exacyl® at H+3 / H+7 and H+11 Receives: Other: Placebo of Exacyl® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total blood loss
Total Blood Loss (TBL) in mL of red blood cells, calculated using Mercuriali's formula at 100% haematocrit (Ht) and then converted to mL of blood at 35% Ht
Measured: Between Day-1of surgery and Day+3 of surgery (5 days)
Secondary outcomes (8)
Difference in haemoglobin level (g/dL) between Day-1 and Day+3
Measured: 5 days
Maximum difference in haemoglobin level (g/dL) from D-1 up to D+3
Measured: 5 days
Number of transfusions and volume in mL performed during hospitalisation (operating theatre and unit)
Measured: 5 days
Major haemorrhagic events, clinically significant non-major haemorrhagic events and minor haemorrhagic events
Measured: 3 month
Surgical revision
Measured: 3 month
Occurrence of venous or arterial thromboembolic events
Measured: 3 month
Local infectious complications
Measured: 3 month
Death due to any cause and death due to cardiovascular cause
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2015 (estimated)
- Study start20 Oct 2015
- Primary completion29 Aug 2017
- Study completion29 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Loss After a Total Hip ReplacementStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 231 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02403596
- Sponsor's protocol ID
- ESPER
- Other IDs
- RB15.005
- Acronym
- ESPER
- Status last verified
- Jan 2018
- First submitted
- 13 Mar 2015
- Last updated
- 9 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study ESPER: Blood-sparing During the Placement of a Total Hip Prosthesis With the Exacyl® in Patients Treated With Rivaroxaban, Phase IV
- ClinicalTrials.gov ID
- NCT02403596
- Acronym / sponsor ID
- ESPER / ESPER
- Conditions
- Blood Loss After a Total Hip Replacement
- Keywords
- Hip replacement, rivaroxaban, exacyl, blood loss
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 231 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- 20 Oct 2015 (actual)
- Primary completion
- 29 Aug 2017 (actual)
- Study completion
- 29 Aug 2017 (actual)
- First posted
- 31 Mar 2015 (estimated)
- 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.
This study evaluates the efficacy of tranexamic acid versus placebo on perioperative blood loss using two dosage regimens (standard and extended) after a surgery during total hip arthroplasty in patients receiving the novel fast-acting oral anticoagulant rivaroxaban for prophylaxis of thrombosis.
Detailed description
In 2011, 140 000 total hip replacements were performed and bleeding remains one of the major complications responsible for significant morbidity. This study will evaluate a new treatment to prevent bleeding due to this surgery. Indeed, the tranexamic acid (Exacyl) will be used in two modes of administration (standard or extended) versus placebo combined with a Rivaroxaban treatment at a dose of 10 mg / day for 35 days.
Patients will be randomized (exacyl standard vs exacyl extended vs. placebo) and will be followed for 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: Exacyl®: Standard treatment | Experimental | Drug: Exacyl®, Other: Placebo of Exacyl®Intravenous use. 1g Exacyl® at H0 (Hour = 0 in other term at the time of incision) then 1g Exacyl® at H+3 then 1g Exacyl® placebo at H+7 and H+11 |
| Group 2: Exacyl®: Extended treatment | Experimental | Drug: Exacyl®Intravenous use. 1g Exacyl® at H0 (Hour = 0 in other term at the time of incision) then 1g Exacyl® at H+3 / H+7 and H+11 |
| Group 3: Placebo | Placebo comparator | Other: Placebo of Exacyl®This group will receive a placebo of Exacyl®: 1g placebo of Exacyl® at H0 (Hour = 0 in other term at the time of incision) then 1g placebo of Exacyl® at H+3 / H+7 and H+11 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Over 18 years of age
- Scheduled to undergo elective non-traumatic primary cementless THA
- Having given written informed consent to participate in the trial
- Covered by Social Security
Key exclusion criteria (16 listed)
- Rapidly destructive arthrosis of the hip
- History of prior surgery on the operative hip
- Contraindications to the use of tranexamic acid:
- Contraindications to the use of rivaroxaban
- Cognitive disorder that precludes giving informed consent
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 |
|---|---|---|
| Exacyl®Also: Tranexamic acid | Drug | Group 1: Exacyl®: Standard treatment, Group 2: Exacyl®: Extended treatment |
| Placebo of Exacyl® | Other | Group 1: Exacyl®: Standard treatment, Group 3: Placebo |
Primary outcome
Total blood loss
Time frame: Between Day-1of surgery and Day+3 of surgery (5 days)
Total Blood Loss (TBL) in mL of red blood cells, calculated using Mercuriali's formula at 100% haematocrit (Ht) and then converted to mL of blood at 35% Ht
8 secondary outcomes
Difference in haemoglobin level (g/dL) between Day-1 and Day+3
Time frame: 5 days
Maximum difference in haemoglobin level (g/dL) from D-1 up to D+3
Time frame: 5 days
Number of transfusions and volume in mL performed during hospitalisation (operating theatre and unit)
Time frame: 5 days
Major haemorrhagic events, clinically significant non-major haemorrhagic events and minor haemorrhagic events
Time frame: 3 month
Surgical revision
Time frame: 3 month
Occurrence of venous or arterial thromboembolic events
Time frame: 3 month
Local infectious complications
Time frame: 3 month
Death due to any cause and death due to cardiovascular cause
Time frame: 3 month
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 9 Jan 2018.
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Exacyl® in people with Blood Loss After a Total Hip Replacement, run by University Hospital, Brest at 4 sites 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 4 inclusion and 16 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 9 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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: Between Day-1of surgery and Day+3 of surgery (5 days)). 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 9 Jan 2018; AzTrials last refreshed its copy on 7 Nov 2026.