Generation of Thrombin and Prediction of Deep Vein Thrombosis Post Prosthetic Orthopedic Surgery of the Lower Limbs (GT-PT)

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 Overview

• Status: Completed
• Conditions: Deep Vein Thrombosis; Knee Prosthesis; Total Hip Prosthesis
• Intervention / Treatment: Biological: Blood test; Other: Doppler ultrasound

• Study Type: Interventional
• Enrollment (Actual): 146
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Nîmes, France, 30029
    • Nîmes University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: interventional group	Biological: Blood test; Additional blood test of 4,5 ml of venous blood; Other: Doppler ultrasound; Vascular ultrasonic vascular exploration of the lower limbs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Day 0
Occurrence of Symptomatic pulmonary embolism	yes/non	Day 7 (± 2)
Occurrence of Symptomatic deep vein thrombosis somewhere in the body	Yes/no	Day 7 (± 2)
Occurrence of Symptomatic deep vein thrombosis in legs	Yes/non	Day 7 (± 2)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of proximal Symptomatic deep vein thrombosis in legs	Yes/no	Day 7 (± 2)
Occurrence of distal Symptomatic deep vein thrombosis in legs	Yes/no	Day 7 (± 2)
Occurrence of muscular Symptomatic deep vein thrombosis in legs	Yes/no	Day 7 (± 2)
Occurrence of any kind of Symptomatic deep vein thrombosis in legs except muscular	Yes/no	Day 7 (± 2)
Occurrence of proximal asymptomatic deep vein thrombosis in legs by doppler ultrasound	Yes/no	Day 7 (± 2)
Occurrence of distal asymptomatic deep vein thrombosis in legs by doppler ultrasound	Yes/no	Day 7 (± 2)
Occurrence of muscular asymptomatic deep vein thrombosis in legs by doppler ultrasound	Yes/no	Day 7 (± 2)
Occurrence of any kind of asymptomatic deep vein thrombosis except muscular in legs by doppler ultrasound	Yes/no	Day 7 (± 2)

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Eva Cochery-Nouvellon, Dr, Centre Hospitalier Universitaire de Nîmes

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2019
• Primary Completion (Actual): February 20, 2023
• Study Completion (Actual): October 17, 2023

Study Registration Dates

• First Submitted: August 7, 2018
• First Submitted That Met QC Criteria: August 15, 2018
• First Posted (Actual): August 16, 2018

Study Record Updates

• Last Update Posted (Actual): February 11, 2026
• Last Update Submitted That Met QC Criteria: February 9, 2026
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Embolism and Thrombosis; Thrombosis; Venous Thrombosis; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests
• Other Study ID Numbers: NIMAO/2017-01/ECN-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No