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

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.

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Key information

Conditions

Deep Vein Thrombosis Cardiovascular Diseases Embolism and Thrombosis Inflammatory Response Thrombosis Vascular Diseases Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Amiens

Amiens, 80480, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

I-CAM levels variation in acute DVT patient

Time frame: one year

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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Acronym: Aticks Live

Important dates

Study start: 2021
Primary completion: 2023
Study completion: 2025
First posted: Feb 5, 2021
Registry last updated: May 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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