Status:
ACTIVE_NOT_RECRUITING
Effect of Tinzaparin on Inflammatory Biomarkers During the Acute Phase of Deep Vein Thrombosis
Lead Sponsor:
Centre Hospitalier Universitaire, Amiens
Conditions:
Deep Vein Thrombosis
Inflammatory Response
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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....
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
February 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2025
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT04741464
Start Date
February 2 2021
End Date
November 1 2025
Last Update
May 29 2025
Active Locations (1)
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1
CHU Amiens
Amiens, France, 80480