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

Primary Purpose

Deep Vein Thrombosis, Inflammatory Response

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Tinzaparin
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Deep Vein Thrombosis focused on measuring Deep Vein Thrombosis, Inflammatory Response

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • CHU AmiensRecruiting

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 2, 2021
Last Updated
May 16, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
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1. Study Identification

Unique Protocol Identification Number
NCT04741464
Brief Title
Effect of Tinzaparin on Inflammatory Biomarkers During the Acute Phase of Deep Vein Thrombosis
Acronym
Aticks Live
Official Title
Effect of Tinzaparin on Inflammatory Biomarkers During the Acute Phase of Deep Vein Thrombosis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 2, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deep Vein Thrombosis, Inflammatory Response
Keywords
Deep Vein Thrombosis, Inflammatory Response

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Tinzaparin
Intervention Description
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 Outcome Measure Information:
Title
I-CAM levels variation in acute DVT patient
Description
The main objective of the present study is to illustrate the I-CAM serum levels decrease after an acute DVT.
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marie-Antoinette Sevestre, Pr
Phone
0322087290
Email
sevestre.marie-antoinette@chu-amiens.fr
Facility Information:
Facility Name
CHU Amiens
City
Amiens
ZIP/Postal Code
80480
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sevestre Marie-Antoinette, Pr
Phone
0322087290
Email
sevestre.marie-antoinette@chu-amiens.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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