Study of the Prognostic Value of the Coagulolytic Balance Dependent on Circulating Microvesicles in the Occurrence of Thrombotic Events After Total Knee Replacement in Orthopedic Surgery.

NCT ID: NCT05387694

Last Updated: 2023-04-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 387 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-30
• Study Completion Date: 2026-12-31

Brief Summary

This is a prospective multicenter cohort study to evaluate the prognostic value of new biological markers in predicting thrombotic events after orthopedic surgery. According to the inclusion and non-inclusion criteria below, the study will include 387 major subjects who will undergo first-line total knee replacement and will receive the same standard prophylactic treatment: anticoagulation with Lovenox® (enoxaparin) 4000 IU/d subcutaneously 6 to 8 hours postoperatively and then daily for 15 days in combination with compression stockings.

Detailed Description

Recruitment and follow-up of patients will be carried out in 3 hospitals by the respective orthopedic teams. Three hundred and eighty-seven patients will be included in the study, over a period of 36 months: 200 in Marseille, 100 in Nice and 87 in Nîmes.

The objective of the study was to evaluate the prognostic capacities of the coagulolytic balance of MVs measured after surgery at D0 in the occurrence of a symptomatic or asymptomatic venous thromboembolic event revealed by echodoppler at 1 month after total knee replacement surgery.

The management of the subjects is unchanged from the current recommendations and will be homogeneous between the three inclusion centers. Patients will be hospitalized for 5 days and will receive the usual prophylactic anticoagulant treatment with Lovenox® (enoxaparin sodium; LMWH) 4000 IU/d subcutaneously 6 to 8 hours postoperatively and then daily for 15 days in combination with compression stockings, which corresponds to the management of a PTG according to current recommendations.

Conditions

Knee Prosthesis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Knee prosthesis group

Group Type: EXPERIMENTAL

Thrombotic risk assessment

Intervention Type: OTHER

Collection of symptomatic thrombotic events occurring during the 5 days of hospitalization and then by telephone interview at M1 +/- 3 days. Complete echodoppler (proximal and distal) performed at M1 to highlight asymptomatic thrombotic events.

Interventions

Thrombotic risk assessment

Collection of symptomatic thrombotic events occurring during the 5 days of hospitalization and then by telephone interview at M1 +/- 3 days. Complete echodoppler (proximal and distal) performed at M1 to highlight asymptomatic thrombotic events.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Subject, male or female, aged 18 to 85 years (upper age limit classically used in the literature of PTG79-81)
• First-line TKP (knee native to any prosthesis) performed to treat primary or secondary osteoarthritis.

In case of contralateral PTG, a delay of 12 months between the 2 prostheses will be respected according to the habits of the inclusion centers.

• ASA score <4 (American Society of Anesthesiologists)
• No contraindication to prophylactic treatment with low molecular weight heparin (LMWH)
• Subject not taking anticoagulant or antiaggregant therapy at therapeutic dose
• Subject who has signed the informed consent form
• Subject affiliated to the social security system

Exclusion Criteria

• Subjects with a history of sepsis, tumor or trauma in the considered joint
• Subject with sepsis or acute infection
• Immunocompromised subject (HIV, transplant, chemotherapy, leukemia, glucocorticoids >3 months)
• Subjects with severe respiratory, circulatory or cardiac pathologies involving anticoagulant treatment likely to influence the coagulolytic balance.
• Subject with severe renal insufficiency (creatinine clearance < 30ml/min)
• Subject refusing to participate in the study or not signing the informed consent or unable to adhere to the study procedures
• Subjects who are minors, pregnant or breastfeeding, not affiliated with the social security system, or deprived of liberty
• Subject already included in an interventional trial (which may alter the results of that study)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

François CREMIEUX

Role: STUDY_DIRECTOR

Assistance Publique Hopitaux De Marseille

Matthieu OLLIVIER

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique Hopitaux De Marseille

Locations

Assistance Publique Hopitaux de Marseille

Marseille, Bouches Du Rhône, France

Countries

France

Central Contacts

Matthieu OLLIVIER

Role: CONTACT

matthieu.ollivier@ap-hm.fr

04.91.74.50.12 ext. +33

Facility Contacts

Alexandra GIULIANI

Role: primary

alexandra.giuliani@ap-hm.fr

Other Identifiers

2022-A00582-41

Identifier Type: -

Identifier Source: org_study_id