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.

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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.

Первичные конечные точки

• Area under the Receiver Operating Characteristic curve [Срок оценки: After surgery at Day 0]

Вторичные конечные точки (4)

• Best prognostic threshold of MV coagulolytic balance measured [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Day 0, Day 3 and 1 month post-PTG]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Франция · 1 центр

• Assistance Publique Hopitaux de Marseille — Marseille

Идентификаторы

NCT: NCT05387694 · 2022-A00582-41

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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