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

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-005467-31-FR

Enrollment

Registered

2020-11-30

Start date

2021-01-28

Completion date

Unknown

Last updated

2024-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute phase of deep vein thrombosis

Interventions

Trade Name: INNOHEP Product Name: Tinzaparine Pharmaceutical Form: Injection

Eligibility

Sex/Gender

All

Inclusion 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 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

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

Design outcomes

Secondary

Measure	Time frame
Secondary end point(s): Levels of other biological inflammation markers during the study (CRP, IL-6, IL-8, IL-10, Pselectin, TFPI, D Dimers, NETS, MMP2, MMP9, VIII, TGT,PPL-ct, C3c, C4c, Xa activity, factor II and IV) - Percentage of complete recanalization measured by duplex ultrasoundat day 21 - Comparison between recanalization and inflammatory markers ;Timepoint(s) of evaluation of this end point: Day 1, 3,5,7,10,15 and day 21	—

Measure

Time frame

Secondary end point(s): Levels of other biological inflammation markers during the study (CRP, IL-6, IL-8, IL-10, Pselectin, TFPI, D Dimers, NETS, MMP2, MMP9, VIII, TGT,PPL-ct, C3c, C4c, Xa activity, factor II and IV) - Percentage of complete recanalization measured by duplex ultrasoundat day 21 - Comparison between recanalization and inflammatory markers ;Timepoint(s) of evaluation of this end point: Day 1, 3,5,7,10,15 and day 21

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Primary

Measure	Time frame
Main Objective: to illustrate the I-CAM serum levels decrease after an acute DVT;Secondary Objective: - To evaluate the relationship between inflammatory markers and clinical symptoms. - To evaluate the relationship between inflammatory markers and the number of patients with partial recanalization (50%) or complete recanalization at 21 days. ;Primary end point(s): CAM levels variation in each patient during time;Timepoint(s) of evaluation of this end point: day 21	—

Measure

Time frame

Main Objective: to illustrate the I-CAM serum levels decrease after an acute DVT;Secondary Objective: - To evaluate the relationship between inflammatory markers and clinical symptoms. - To evaluate the relationship between inflammatory markers and the number of patients with partial recanalization (50%) or complete recanalization at 21 days. ;Primary end point(s): CAM levels variation in each patient during time;Timepoint(s) of evaluation of this end point: day 21

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Countries

France

Contacts

Public ContactProject Manager

CHU Amiens-Picardie

mattoug.salah@chu-amiens.fr

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026