Deep Vein ThrombosisAticks LiveNCT04741464
Effect of Tinzaparin on Inflammatory Biomarkers During the Acute Phase of Deep Vein Thrombosis
A study testing Tinzaparin in people with Deep Vein Thrombosis and Inflammatory Response, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deep Vein Thrombosis, Inflammatory Response
- What is being tested?
- Tinzaparin
- How many people
- 9 participants
- Where
- 1 siteFrance
- Study dates
- 2 Feb 2021to Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 19Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Tinzaparin
- Keywords
- Deep Vein Thrombosis, Inflammatory Response
- Medical subject headings
- Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TinzaparinDrug
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start2 Feb 2021
- Primary completion22 Nov 2023
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Vein ThrombosisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04741464
- Sponsor's protocol ID
- PI2020_843_0142
- Acronym
- Aticks Live
- Status last verified
- May 2025
- First submitted
- 2 Feb 2021
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Tinzaparin on Inflammatory Biomarkers During the Acute Phase of Deep Vein Thrombosis
- ClinicalTrials.gov ID
- NCT04741464
- Acronym / sponsor ID
- Aticks Live / PI2020_843_0142
- Conditions
- Deep Vein Thrombosis, Inflammatory Response
- Keywords
- Deep Vein Thrombosis, Inflammatory Response
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 2 Feb 2021 (actual)
- Primary completion
- 22 Nov 2023 (actual)
- Study completion
- Nov 2025 (estimated)
- First posted
- 5 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TinzaparinTinzaparin 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. | Drug | – |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tinzaparin in people with Deep Vein Thrombosis and Inflammatory Response, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
I-CAM levels variation in acute DVT patient (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2025.