Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Starting soon Not applicable

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 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2023-06
Last updated
2023-04-21

Condition(s) studied

Knee Prosthesis

Investigational drug(s) / intervention(s)

Thrombotic risk assessment

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
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)

Primary outcome measure(s)

  • Area under the Receiver Operating Characteristic curve — After surgery at Day 0
    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).

Trial sites (1)

FacilityCityRegionStatus
Assistance Publique Hopitaux de Marseille Marseille Bouches Du Rhône
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05387694 on ClinicalTrials.gov ↗ ← All trials in France