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

Sponsor

Centre Hospitalier Universitaire, Amiens (Other)

Overall Status

Recruiting

CT.gov ID

NCT04741464

Collaborator

(none)

Enrollment

Location

12.9

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Deep Vein Thrombosis Inflammatory Response	Drug: Tinzaparin	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

12 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 2, 2021

Anticipated Primary Completion Date :

Feb 1, 2022

Anticipated Study Completion Date :

Mar 1, 2022

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)