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

NCT04741464 | Active Not Recruiting

• 1 other identifier: PI2020_843_0142
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Deep Vein Thrombosis; Inflammatory Response

Keywords

Deep Vein Thrombosis; Inflammatory Response

Outcome Measures

Primary Outcomes (1)

• I-CAM levels variation in acute DVT patient

  The main objective of the present study is to illustrate the I-CAM serum levels decrease after an acute DVT.

  one year

Interventions

Tinzaparin DRUG

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens

Amiens, 80480, France

Location

MeSH Terms

Conditions

Venous Thrombosis

Interventions

Tinzaparin

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: February 5, 2021
• Study Start: February 2, 2021
• Primary Completion: November 22, 2023
• Study Completion: November 1, 2025
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)