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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03634124
Other study ID # NIMAO/2017-01/ECN-01
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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.

Study Design


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)
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