Generation of Thrombin and Prediction of Deep Vein Thrombosis Post Prosthetic Orthopedic Surgery of the Lower Limbs

Phase 3

Completed

• Conditions: Deep Vein Thrombosis; Total Hip Prosthesis; Knee Prosthesis
• Interventions: Biological: Blood test; Other: Doppler ultrasound

• Registration Number: NCT03634124
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief 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 or knee prosthesis.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-07
• Study First Submitted QC: 2018-08-15
• Study First Posted: 2018-08-16
• Study Start: 2019-02-21
• Primary Completion: 2023-02-20
• Study Completion: 2023-10-17
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-17
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 146

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
interventional group	Blood test	-
interventional group	Doppler ultrasound	-

Primary Outcome Measures

Name	Time	Method
Occurrence of Symptomatic pulmonary embolism	Day 7 (± 2)	yes/non
Occurrence of Symptomatic deep vein thrombosis in legs	Day 7 (± 2)	Yes/non
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	Day 0	Numerical value
Occurrence of Symptomatic deep vein thrombosis somewhere in the body	Day 7 (± 2)	Yes/no

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Nimes University Hospital; 🇫🇷 Nîmes, France