Effect of Tinzaparin on inflammatory biomarkers during the acute phase of deep vein thrombosis

Phase 1

• Conditions: acute phase of deep vein thrombosis; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2020-005467-31-FR
• Lead Sponsor: CHU Amiens-Picardie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-30
• Last Update Posted: 8 January 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 12

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 8
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

Exclusion Criteria

- Recent DVT (less than 2 months) other than the index event with or without PE
- Severe ilio-femoral DVT requiring recanalization
- Duration of treatment of more than 24 h since diagnosis
- 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
- Any anti-inflammatory drugs or anti-platelet therapy
- Any other concomitant anticoagulant treatment such as VKA, heparin, fondaparinux
- Contraindications to LMWH according to their SmPC

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified