ThrombophlebitisPhase 3NCT00362947
Different Doses and Duration of Low Molecular Weight Heparin (Parnaparin)in Superficial Vein Thrombosis
A Phase 3 study testing LMWH parnaparin subcutaneously in people with Thrombophlebitis, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 2 sites in Italy.
Trial summary
The optimal treatment of superficial venous thrombosis (SVT) is still uncertain. Though low molecular weight heparin (LMWH) is considered the treatment of choice, studies conducted so far do not give clear indications of the optimal dose and duration of treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thrombophlebitis
- What is being tested?
- LMWH parnaparin subcutaneously
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 664 participants
- Where
- 2 sitesItaly
- Study dates
- Aug 2006to Feb 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Weight > 50 kg and less than 110 kg
- SVT of the grand saphenous vein for at least 4 cm
- SVT of the small saphenous vein for at least 4 cm
- Collateral SVT of the large saphenous vein of the thigh for at least 4cm
Who cannot join
- SVT of the grand saphenous vein reaching the saphenofemoral cross (within 3 cm)
- SVT of the small saphenous vein reaching the saphenopopliteal cross
- Documented proximal or distal DVT or pulmonary embolism
- SVT secondary to sclerotherapy
- Pregnancy and puerperium
- uncontrolled arterial hypertension (Systolic pressure > 180 mmHg and diastolic pressure > 110 mmHg)
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- Active peptic ulcer
- Bacterial endocarditis
- Stroke in the previous 3 months
- Haemorrhagic diathesis
- Thrombocytopenia (platelets < 100,000/ µL)
- Hypersensitivity to heparin or history of thrombocytopenia induced by heparin
- Creatinine > 2 mg% (> 180 µmol/L)
- Heparin therapy (any dose) or anticoagulant therapy for longer than the previous 72 hours
- In-hospital development of SVT
- Previous saphenectomy by any method
- Surgery in the previous 30 days
- Serious liver disease
- Use of dextran, mannitol, thrombolytic treatment, chronic use of NSAID and cortisone-based drugs.
- Active cancer or under chemotherapy or radiotherapy
- Thrombectomy of superficial vein involved
- Refusal to give informed consent
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Dept. Angiology & Blood Coagulation; University Hospital S.Orsola-Malpighi
Bologna, BO, 40138
U.O. Medicina Critica
Piacenza, PC, 29100
About this study
Official title: Randomized Clinical Study of Different Treatment Doses and Duration of Low Molecular Weight Heparin (Parnaparin) in Superficial Vein Thrombosis
The optimal treatment of superficial venous thrombosis (SVT) is still uncertain. Though low molecular weight heparin (LMWH) is considered the treatment of choice, studies conducted so far do not give clear indications of the optimal dose and duration of treatment. This study aims to evaluate whether an intermediate therapeutic dose of LMWH (parnaparin) is more effective than a prophylactic dose and also to assess whether 10 rather than 30 days are sufficient for treatment.
Read the detailed description
Outpatients with an episode of SVT of the grand saphenous vein (for at least 4 cm), and/or SVT of the small saphenous vein (for at least 4 cm), and/or SVT of a collateral vein of the large saphenous vein of the thigh (for at least 4cm) are included in this prospective, randomised, double blind, national multicentre study.
Patients will be randomised into double-blind groups to receive (syringes will be identical in appearance) in consecutively numbered boxes:
A - Parnaparin, dose of 8,500 IU aXa taken subcutaneously once a day for 10 days B - Parnaparin, dose of 8,500 IU aXa per day for 10 days followed by Parnaparin 6,400 IU aXa per day for the subsequent three weeks. C - Parnaparin, dose of 4,250 IU aXa per day for 30 days Elastic compression treatment will be recommended with special stocking and/or elastic bandaging with compression to the ankles of 20-40 mmHg, where not contraindicated.
- Conditions
- Thrombophlebitis
- Being tested
- LMWH parnaparin subcutaneously
- Keywords
- Superficial vein thrombosis, thrombophlebitis, LMWH, parnaparin
- Medical subject headings
- Thrombophlebitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LMWH parnaparin subcutaneouslyDrug
| Study group | Role | What they receive |
|---|---|---|
| A | Placebo comparator | A - Parnaparin 8.500 UI aXa od (therapeutic doses) for 10 days followed by placebo for 20 days Receives: Drug: LMWH parnaparin subcutaneously |
| B | Active comparator | B - Parnaparin 8.500 UI aXa od for 10 days followed by 6.400 UI aXa once daily (intermediate therapeutic doses) for 20 days Receives: Drug: LMWH parnaparin subcutaneously |
| C | Active comparator | C - Parnaparin 4.250 UI aXa od (prophylactic doses) for 30 days Receives: Drug: LMWH parnaparin subcutaneously |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary effectiveness objectives
composite of symptomatic and asymptomatic DVT, relapse and/or symptomatic or asymptomatic local extension of SVT and symptomatic PE at 33 days.
Measured: 33 days
Major bleeding
Bleeding events were defined as major if retroperitoneal, intracranial, intraocular with severe vision damage, intra-articular, intra-abdominal of upper or lower digestive tract, genito-urinary tract, respiratory tract or associated with a decrease in the haemoglobin of ≥ 2.0 g/dL, or if requiring transfusion of ≥2 units of blood or if fatal.
Bleeding was classified as minor in all other cases.
Measured: 33
Secondary outcomes (2)
Secondary effectiveness objectives
i)- reduction in local symptoms during treatment and ii)- the combined efficacy end-point during a follow-up of 93 days after the start of treatment.
Measured: 93
secondary outcome for safety
the composite of minor haemorrhages, thrombocytopenia or any other adverse events (e.g. local allergic reactions).
Measured: 33
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2006 (estimated)
- Study startAug 2006
- Primary completionSep 2010
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombophlebitisStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 664 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GUALTIERO PALARETI, IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Investigators
- Gualtiero Palareti, MD, Study chair, University of BolognaBenilde Cosmi, MD PhD, Principal investigator, University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00362947
- Sponsor's protocol ID
- The Steflux study
- Status last verified
- Mar 2021
- First submitted
- 11 Aug 2006
- Last updated
- 19 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Study of Different Treatment Doses and Duration of Low Molecular Weight Heparin (Parnaparin) in Superficial Vein Thrombosis
- ClinicalTrials.gov ID
- NCT00362947
- Acronym / sponsor ID
- The Steflux study
- Conditions
- Thrombophlebitis
- Keywords
- Superficial vein thrombosis, thrombophlebitis, LMWH, parnaparin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 664 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- Sep 2010 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 15 Aug 2006 (estimated)
- 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.
The optimal treatment of superficial venous thrombosis (SVT) is still uncertain. Though low molecular weight heparin (LMWH) is considered the treatment of choice, studies conducted so far do not give clear indications of the optimal dose and duration of treatment. This study aims to evaluate whether an intermediate therapeutic dose of LMWH (parnaparin) is more effective than a prophylactic dose and also to assess whether 10 rather than 30 days are sufficient for treatment.
Detailed description
Outpatients with an episode of SVT of the grand saphenous vein (for at least 4 cm), and/or SVT of the small saphenous vein (for at least 4 cm), and/or SVT of a collateral vein of the large saphenous vein of the thigh (for at least 4cm) are included in this prospective, randomised, double blind, national multicentre study.
Patients will be randomised into double-blind groups to receive (syringes will be identical in appearance) in consecutively numbered boxes:
A - Parnaparin, dose of 8,500 IU aXa taken subcutaneously once a day for 10 days B - Parnaparin, dose of 8,500 IU aXa per day for 10 days followed by Parnaparin 6,400 IU aXa per day for the subsequent three weeks. C - Parnaparin, dose of 4,250 IU aXa per day for 30 days Elastic compression treatment will be recommended with special stocking and/or elastic bandaging with compression to the ankles of 20-40 mmHg, where not contraindicated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Placebo comparator | Drug: LMWH parnaparin subcutaneouslyA - Parnaparin 8.500 UI aXa od (therapeutic doses) for 10 days followed by placebo for 20 days |
| B | Active comparator | Drug: LMWH parnaparin subcutaneouslyB - Parnaparin 8.500 UI aXa od for 10 days followed by 6.400 UI aXa once daily (intermediate therapeutic doses) for 20 days |
| C | Active comparator | Drug: LMWH parnaparin subcutaneouslyC - Parnaparin 4.250 UI aXa od (prophylactic doses) for 30 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Weight > 50 kg and less than 110 kg
- SVT of the grand saphenous vein for at least 4 cm
- SVT of the small saphenous vein for at least 4 cm
- Collateral SVT of the large saphenous vein of the thigh for at least 4cm
Key exclusion criteria (22 listed)
- SVT of the grand saphenous vein reaching the saphenofemoral cross (within 3 cm)
- SVT of the small saphenous vein reaching the saphenopopliteal cross
- Documented proximal or distal DVT or pulmonary embolism
- SVT secondary to sclerotherapy
- Pregnancy and puerperium
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 |
|---|---|---|
| LMWH parnaparin subcutaneously | Drug | A, B, C |
Primary outcome
Primary effectiveness objectives
Time frame: 33 days
composite of symptomatic and asymptomatic DVT, relapse and/or symptomatic or asymptomatic local extension of SVT and symptomatic PE at 33 days.
Major bleeding
Time frame: 33
Bleeding events were defined as major if retroperitoneal, intracranial, intraocular with severe vision damage, intra-articular, intra-abdominal of upper or lower digestive tract, genito-urinary tract, respiratory tract or associated with a decrease in the haemoglobin of ≥ 2.0 g/dL, or if requiring transfusion of ≥2 units of blood or if fatal. Bleeding was classified as minor in all other cases.
2 secondary outcomes
Secondary effectiveness objectives
Time frame: 93
secondary outcome for safety
Time frame: 33
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2021.
- Individual participant dataSharing planned: No
Related trials for Thrombophlebitis
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Implementing an Evidence-based, Standardized Care Bundle Targeting Register Nurses and Anaesthesiologists, to Enhance Patient Safety and Quality of Intravascular Access Devices Care Management - The Safe-IVADs Project. A Longitudinell Implementation Intervention With an Embedded Process Evaluation.
Phlebitis, Thrombophlebitis
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.
Gualtiero Palareti, MD study chair
University of Bologna
Benilde Cosmi, MD PhD principal investigator
University of Bologna
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing LMWH parnaparin subcutaneously in people with Thrombophlebitis, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 2 sites in Italy.
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 22 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: finished, as of the sponsor's last update on 19 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Primary effectiveness objectives (time frame: 33 days). The study lists 2 primary outcomes in all. 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 19 Mar 2021.