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

Deep Vein Thrombosis Clinical Trial

— GT-PT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03634124
• Other study ID #: NIMAO/2017-01/ECN-01
• Status: Completed
• Phase: Phase 3
• Start date: February 21, 2019
• Est. completion date: October 17, 2023

Study information

• Verified date: November 2023
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 or knee prosthesis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: October 17, 2023
• Est. primary completion date: February 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Knee Prosthesis
• Thrombosis
• Total Hip Prosthesis
• Venous Thrombosis

Intervention

Biological:
• Blood test
Additional blood test of 4,5 ml of venous blood

Other:
• Doppler ultrasound
Vascular ultrasonic vascular exploration of the lower limbs

Locations

Country	Name	City	State
France	Nimes University Hospital	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Occurrence of Symptomatic pulmonary embolism	yes/non	Day 7 (± 2)
Primary	Occurrence of Symptomatic deep vein thrombosis somewhere in the body	Yes/no	Day 7 (± 2)
Primary	Occurrence of Symptomatic deep vein thrombosis in legs	Yes/non	Day 7 (± 2)
Secondary	Occurrence of proximal Symptomatic deep vein thrombosis in legs	Yes/no	Day 7 (± 2)
Secondary	Occurrence of distal Symptomatic deep vein thrombosis in legs	Yes/no	Day 7 (± 2)
Secondary	Occurrence of muscular Symptomatic deep vein thrombosis in legs	Yes/no	Day 7 (± 2)
Secondary	Occurrence of any kind of Symptomatic deep vein thrombosis in legs except muscular	Yes/no	Day 7 (± 2)
Secondary	Occurrence of proximal asymptomatic deep vein thrombosis in legs by doppler ultrasound	Yes/no	Day 7 (± 2)
Secondary	Occurrence of distal asymptomatic deep vein thrombosis in legs by doppler ultrasound	Yes/no	Day 7 (± 2)
Secondary	Occurrence of muscular asymptomatic deep vein thrombosis in legs by doppler ultrasound	Yes/no	Day 7 (± 2)
Secondary	Occurrence of any kind of asymptomatic deep vein thrombosis except muscular in legs by doppler ultrasound	Yes/no	Day 7 (± 2)