Deep Vein ThrombosisPhase 3GT-PTNCT03634124
Generation of Thrombin and Prediction of Deep Vein Thrombosis Post Prosthetic Orthopedic Surgery of the Lower Limbs
A Phase 3 study testing Blood test and Doppler ultrasound in people with Deep Vein Thrombosis and Total Hip Prosthesis, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
The numerical ratio between the value of the thrombin generation test performed without soluble thrombomodulin and the value of the thrombin generation test performed in the presence of soluble thrombomodulin, performed pre-surgically, could predict the risk of early venous thromboembolism after placement of total hip… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deep Vein Thrombosis, Total Hip Prosthesis, Knee Prosthesis
- What is being tested?
- Blood test and Doppler ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteFrance
- Study dates
- 21 Feb 2019to 17 Oct 2023
- 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
- The patient must have his consent and signed the consent form.
- The patient must affiliated or a beneficiary of a health insurance plan.
- The patient is at least 18 years old
- Patient with an indication of total hip prosthesis or total knee replacement surgery set unilateral
Who cannot join
- The patient is participating in another interventional study.
- The patient is in an exclusion period determined by a previous study.
- Minor patients, people in emergency situations.
- The patient is under the protection of justice, guardianship or curatorship.
- The patient refuses to sign the consent.
- It is not possible to inform the patient.
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- The patient is pregnant, parturient, or breastfeeding.
- The patient has a contraindication (or incompatible drug combination) to drug thromboprophylaxis applied according to good clinical practice and recommendations of learned societies
- Long-term anticoagulant therapy for personal thrombotic history.
- Known hemorrhagic disease.
- Haemorrhagic risk perceived during the consultation of preoperative anesthesia, leading to modify / develop the usual thromboprophylaxis.
- Chronic liver disease.
- Chronic renal failure with calculated clearance <30 ml / min.
- Extreme body mass index: <18 kg.m-2 or> 40 kg.m-2
- total hip prosthesis or total knee prosthesis in the immediate aftermath of a bone fracture.
- total hip prosthesis resumption.
- Installation of more than one joint prosthesis.
- Surgery in the previous 3 months.
- Infective push in the previous 3 months.
- Indication of haemostatic treatment for abnormal haemorrhagic risk.
- Severe impairment of renal function with a calculated clearance <30 ml / min.
- Contraindication (allergic, metabolic, other ...) to usual drug thromboprophylaxis.
- Condition requiring dosage adjustment of drug thromboprophylaxis.
- Indication to put in place intermittent pneumatic compression for perioperative thromboprophylaxis.
Trial locations and contacts
1 site in 1 country.
About this study
The numerical ratio between the value of the thrombin generation test performed without soluble thrombomodulin and the value of the thrombin generation test performed in the presence of soluble thrombomodulin, performed pre-surgically, could predict the risk of early venous thromboembolism after placement of total hip or knee prosthesis.
- Conditions
- Deep Vein Thrombosis, Total Hip Prosthesis, Knee Prosthesis
- Being tested
- Blood test, Doppler ultrasound
- Medical subject headings
- Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood testBiological
Additional blood test of 4,5 ml of venous blood
Doppler ultrasoundOther
Vascular ultrasonic vascular exploration of the lower limbs
| Study group | Role | What they receive |
|---|---|---|
| interventional group | Experimental | Not described Receives: Biological: Blood test; Other: Doppler ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimate the numerical ratio between the value of the thrombin generation test performed without soluble thrombomodulin and the value of the thrombin generation test performed in the presence of soluble thrombomodulin
Numerical value
Measured: Day 0
Occurrence of Symptomatic pulmonary embolism
yes/non
Measured: Day 7 (± 2)
Occurrence of Symptomatic deep vein thrombosis somewhere in the body
Yes/no
Measured: Day 7 (± 2)
Occurrence of Symptomatic deep vein thrombosis in legs
Yes/non
Measured: Day 7 (± 2)
Secondary outcomes (8)
Occurrence of proximal Symptomatic deep vein thrombosis in legs
Yes/no
Measured: Day 7 (± 2)
Occurrence of distal Symptomatic deep vein thrombosis in legs
Yes/no
Measured: Day 7 (± 2)
Occurrence of muscular Symptomatic deep vein thrombosis in legs
Yes/no
Measured: Day 7 (± 2)
Occurrence of any kind of Symptomatic deep vein thrombosis in legs except muscular
Yes/no
Measured: Day 7 (± 2)
Occurrence of proximal asymptomatic deep vein thrombosis in legs by doppler ultrasound
Yes/no
Measured: Day 7 (± 2)
Occurrence of distal asymptomatic deep vein thrombosis in legs by doppler ultrasound
Yes/no
Measured: Day 7 (± 2)
Occurrence of muscular asymptomatic deep vein thrombosis in legs by doppler ultrasound
Yes/no
Measured: Day 7 (± 2)
Occurrence of any kind of asymptomatic deep vein thrombosis except muscular in legs by doppler ultrasound
Yes/no
Measured: Day 7 (± 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2018
- Study start21 Feb 2019
- Primary completion20 Feb 2023
- Study completion17 Oct 2023
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 Deep Vein ThrombosisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eva Cochery-Nouvellon, Dr, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03634124
- Sponsor's protocol ID
- NIMAO/2017-01/ECN-01
- Acronym
- GT-PT
- Status last verified
- Nov 2023
- First submitted
- 7 Aug 2018
- Last updated
- 11 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chea M, Nouvellon E, Alonso S, Marchand P, Coulomb R, Kouyoumdjian P, Perin M, Laurent J, Mura T, Perez-Martin A, Bouvier S, Gris JC. Automated thrombin generation assay in patients entering hospital for total hip or knee arthroplasty: A prospective study. Thromb Res. 2026 Feb;258:109591. doi: 10.1016/j.thromres.2026.109591. Epub 2026 Jan 19. No abstract available.
PubMed 41570657
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Generation of Thrombin and Prediction of Deep Vein Thrombosis Post Prosthetic Orthopedic Surgery of the Lower Limbs
- ClinicalTrials.gov ID
- NCT03634124
- Acronym / sponsor ID
- GT-PT / NIMAO/2017-01/ECN-01
- Conditions
- Deep Vein Thrombosis, Total Hip Prosthesis, Knee Prosthesis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 21 Feb 2019 (actual)
- Primary completion
- 20 Feb 2023 (actual)
- Study completion
- 17 Oct 2023 (actual)
- First posted
- 16 Aug 2018 (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.
The numerical ratio between the value of the thrombin generation test performed without soluble thrombomodulin and the value of the thrombin generation test performed in the presence of soluble thrombomodulin, performed pre-surgically, could predict the risk of early venous thromboembolism after placement of total hip or knee prosthesis.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| interventional group | Experimental | Biological: Blood test, Other: Doppler ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The patient must have his consent and signed the consent form.
- The patient must affiliated or a beneficiary of a health insurance plan.
- The patient is at least 18 years old
- Patient with an indication of total hip prosthesis or total knee replacement surgery set unilateral
Key exclusion criteria (24 listed)
- The patient is participating in another interventional study.
- The patient is in an exclusion period determined by a previous study.
- Minor patients, people in emergency situations.
- The patient is under the protection of justice, guardianship or curatorship.
- The patient refuses to sign the 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 |
|---|---|---|
| Blood testAdditional blood test of 4,5 ml of venous blood | Biological | interventional group |
| Doppler ultrasoundVascular ultrasonic vascular exploration of the lower limbs | Other | interventional group |
Primary outcome
Estimate the numerical ratio between the value of the thrombin generation test performed without soluble thrombomodulin and the value of the thrombin generation test performed in the presence of soluble thrombomodulin
Time frame: Day 0
Numerical value
Occurrence of Symptomatic pulmonary embolism
Time frame: Day 7 (± 2)
yes/non
Occurrence of Symptomatic deep vein thrombosis somewhere in the body
Time frame: Day 7 (± 2)
Yes/no
Occurrence of Symptomatic deep vein thrombosis in legs
Time frame: Day 7 (± 2)
Yes/non
8 secondary outcomes
Occurrence of proximal Symptomatic deep vein thrombosis in legs
Time frame: Day 7 (± 2)
Occurrence of distal Symptomatic deep vein thrombosis in legs
Time frame: Day 7 (± 2)
Occurrence of muscular Symptomatic deep vein thrombosis in legs
Time frame: Day 7 (± 2)
Occurrence of any kind of Symptomatic deep vein thrombosis in legs except muscular
Time frame: Day 7 (± 2)
Occurrence of proximal asymptomatic deep vein thrombosis in legs by doppler ultrasound
Time frame: Day 7 (± 2)
Occurrence of distal asymptomatic deep vein thrombosis in legs by doppler ultrasound
Time frame: Day 7 (± 2)
Occurrence of muscular asymptomatic deep vein thrombosis in legs by doppler ultrasound
Time frame: Day 7 (± 2)
Occurrence of any kind of asymptomatic deep vein thrombosis except muscular in legs by doppler ultrasound
Time frame: Day 7 (± 2)
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 11 Feb 2026.
- Results publication: PubMed 41570657Chea M, Nouvellon E, Alonso S, Marchand P, Coulomb R, Kouyoumdjian P, Perin M, Laurent J, Mura T, Perez-Martin A, Bouvier S, Gris JC. Automated thrombin generation assay in patients entering hospital for total hip or knee arthroplasty: A prospective study. Thromb Res. 2026 Feb;258:109591. doi: 10.1016/j.thromres.2026.109591. Epub 2026 Jan 19. No abstract available.
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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.
Eva Cochery-Nouvellon, Dr principal investigator
Centre Hospitalier Universitaire de Nīmes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Blood test and Doppler ultrasound in people with Deep Vein Thrombosis and Total Hip Prosthesis, run by Centre Hospitalier Universitaire de Nīmes 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 4 inclusion and 24 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 11 Feb 2026. 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. 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?
Estimate the numerical ratio between the value of the thrombin generation test performed without soluble thrombomodulin and the value of the thrombin generation test performed in the presence of soluble thrombomodulin (time frame: Day 0). The study lists 4 primary outcomes in all. 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 NCT03634124, 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 11 Feb 2026.