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.

NCT05387694 | Not Yet Recruiting

• 1 other identifier: 2022-A00582-41
• Study Type: interventional
• Target: 387
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Prosthesis

Outcome Measures

Primary Outcomes (1)

• Area under the Receiver Operating Characteristic curve

  To assess the prognostic value of the microvesicle-dependent coagulolytic balance measured after D0 surgery (pre-administration of prophylactic treatment) in the occurrence of a post-total knee replacement thrombotic event (distal or proximal).

  After surgery at Day 0

Secondary Outcomes (4)

• Best prognostic threshold of MV coagulolytic balance measured

  After surgery at Day 0

• Estimation of the area under the ROC curve with its 95% confidence interval - The procoagulant activity of MV is dependent on FT

  Day 0, Day 3 and 1 month post-PTG

• Estimation of the area under the ROC curve with its 95% confidence interval - Fibrinolytic activity of MV

  Day 0, Day 3 and 1 month post-PTG

• Estimation of the area under the ROC curve with its 95% confidence interval - Coagulolytic balance of MV

  Day 0, Day 3 and 1 month post-PTG

Study Arms (1)

Knee prosthesis group

EXPERIMENTAL

Other: Thrombotic risk assessment

Interventions

Thrombotic risk assessment 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.

Knee prosthesis group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, Bouches Du Rhône, 13354, France

Location

Study Officials

• François CREMIEUX

  Assistance Publique Hopitaux De Marseille

  STUDY DIRECTOR

• Matthieu OLLIVIER

  Assistance Publique Hopitaux De Marseille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthieu OLLIVIER

CONTACT

04.91.74.50.12; matthieu.ollivier@ap-hm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2022
• First Posted: May 24, 2022
• Study Start: June 1, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 21, 2023

Record last verified: 2023-04

Locations

FR (1)