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
Active, not recruiting Not applicable

Effect of Tinzaparin on Inflammatory Biomarkers During the Acute Phase of Deep Vein Thrombosis

NCT04741464 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2021-02-02
Last updated
2025-05-29

Condition(s) studied

Deep Vein ThrombosisInflammatory Response

Investigational drug(s) / intervention(s)

Tinzaparin →

Tinzaparin: Tinzaparin 20 000 anti-Xa IU/mL dispensed in graduated syringes of 0.5 mL, 0.7 mL and 0.9 mL at the dose of 175IU/Kg/d. Strategy: Tinzaparin 175 UI/Kg/d for 21 days After this time the physician will continue the treatment of his choice to treat DVT.

Study summary

Anticoagulants influence either coagulation, inflammation and inflammatory processes in deep vein thrombosis (DVT). Acute DVT cause an inflammatory response that may persist for a long period of time. There is a need to describe patterns of change in serum biomarker levels after acute DVT, and explore the association between trajectory biological patterns and clinical evolution in the era of various anticoagulants in the acute phase of treatment in order to be able to further avoid recurrence and late sequelae. It appears that direct oral anticoagulants and heparin alter inflammatory markers in different ways. It is therefore important to study the evolution of markers according to the different treatments used and secondarily to compare them with each other. Tinzaparin is used in the long term in patients with DVT, it is necessary to measure the evolution of inflammatory markers and then in another study to compare with the other molecules.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Adult patients with a first episode of symptomatic, proximal DVT of the lower limbs, confirmed by Duplex Ultrasound (DUS) * Indication for treatment with Tinzaparin * Patient covered by French national health insurance, * Written informed consent. Exclusion Criteria: * Recent DVT (less than 2 months) objectively proven by venous ultrasound - Severe ilio-femoral DVT requiring recanalization * Duration of treatment of more than 24 h since diagnosis * Patients with acute symptoms (leg pain and swelling) for more than 5 days * Planned surgery in the following 3 weeks, impossible to postpone * Active haemorrhage or high risk of haemorrhage * Symptoms of Post Thrombotic Syndrome * Active neoplasm * APL syndrome * Renal insufficiency (Creatinine clearance (Cockcroft-Gault) \<20 mL/min) * Hepatic disease / or Hepatic Insufficiency / or serious liver disease * Hyperkaliemia more than 5 mmol/L * Patients with mechanical prosthetic heart valve * weight more than 105 kgs in order to avoid difficulties with a dosage of 20000UI OF TINZAPARIN Any anti-inflammatory drugs or anti-platelet therapy * Any other concomitant anticoagulant treatment such as VKA, heparin, fondaparinux and direct oral anticoagulants * Contraindications to tinzaparin according to their SmPC * Patient with asthma, If patients need to receive tinzaparin 10000UI antiX-a/0.5ml for the study,(due to sodium metabisulfite in the solution) * Pregnant women or breastfeeding * patient with age under 18 * Patient deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision)

Primary outcome measure(s)

  • I-CAM levels variation in acute DVT patient — one year
    The main objective of the present study is to illustrate the I-CAM serum levels decrease after an acute DVT.

Trial sites (1)

FacilityCityRegionStatus
CHU Amiens Amiens France
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 NCT04741464 on ClinicalTrials.gov ↗ ← All trials in France