Deep Venous ThrombosisPhase 3NCT00628576
Evaluation of Long-Term Sequelae After Thrombophlebitis, i.e. Deep Venous Thrombosis of the Lower Extremities
A Phase 3 study testing unfractionated heparin and Tinzaparin (Leo) in people with Deep Venous Thrombosis, run by Aalborg University Hospital at 1 site in Denmark.
Trial summary
The purpose of the study was to evaluate efficacy and safety of the new acute treatment of deep venous thrombosis by use of low-molecular-weight heparin compared with standard treatment using unfractionated heparin, especially concerning long-term morbidity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deep Venous Thrombosis
- What is being tested?
- unfractionated heparin and Tinzaparin (Leo)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 1993to Jun 2004
- 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
- First DVT with or without known risk factors except overt cancer
- Second DVT more than two years after the first if the patient was without clinical signs of CVI.
Who cannot join
- Contraindication to anticoagulation therapy
- Candidate to thrombectomy with arterious-venous fistula or thrombolytic therapy
- Known cancer at the time of the DVT diagnosis
- Patients unable to cooperate for anticoagulation therapy or manage the tests.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Dept. of Haematology; Aalborg Hospital
Aalborg, North Denmark, 9000
About this study
Official title: Deep Venous Thrombosis. Long-Term Results After Treatment With Either Low-Molecular -Weight Heparin or Unfractionated Heparin. Examinations of the Venous System.
The purpose of the study was to evaluate efficacy and safety of the new acute treatment of deep venous thrombosis by use of low-molecular-weight heparin compared with standard treatment using unfractionated heparin, especially concerning long-term morbidity.
Read the detailed description
Deep-venous thrombosis (DVT) remains a common clinical problem (annual incidence 0.10-0.16%) and long-term morbidity as chronic venous insufficience (CVI) in 10-30%.
As to recurrent DVT, initial treatment with Low-Molecular-Weight Heparin ( to-day's terminology Fractionated Heparin (FH)) and Unfractionated Heparin (UFH) has shown equal efficiency, whereas the efficacy concerning long-term morbidity has only more recently been published.
This study was initiated to compare the efficacy of UFH and FH concerning the incidence of CVI after symptomatic DVT at short-term and long-term follow-up.
- Conditions
- Deep Venous Thrombosis
- Being tested
- unfractionated heparin, Tinzaparin (Leo)
- Keywords
- Deep Venous Thrombosis, lower extremities, Chronic Venous Insufficiency, Postthrombotic Syndrome, Heparins, Low-molecular- weight heparin, Tinzaparin
- Medical subject headings
- Venous Thrombosis, Postthrombotic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
unfractionated heparinDrug
Also called Heparin SAD 1000 IU/ml
UFH: Continuous i.v. infusion 100 IU/kg/4hrs initially and then adjusted to maintain APTT value 1.5 - 2.5 the pre-treatment value
Tinzaparin (Leo)Drug
Also called Innohep (Leo)
FH (Tinzaparin): 175 iu/kg s.c. in the abdomen once daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | UFH: patients treated with unfractionated heparin Receives: Drug: unfractionated heparin |
| 2 | Experimental | FH: patients treated with low-molecular-weight (fractionated) heparin Receives: Drug: Tinzaparin (Leo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical evaluation of chronic venous insufficiency (CVI) - (Postthrombotic Syndrome) based on internationally accepted criteria.
Measured: Two years and 6 to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2008 (estimated)
- Study startOct 1993
- Primary completionJun 2004
- Study completionJun 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Venous ThrombosisStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University
- Investigators
- Benedicte Laursen, MD, DMSc, Principal investigator, Department of Haematology; Aalborg Hospital, 9100 Aalborg, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00628576
- Sponsor's protocol ID
- VN 2003/15 (2-16-4 - 0001- 03)
- Status last verified
- Feb 2008
- First submitted
- 25 Feb 2008
- Last updated
- 5 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Venous Thrombosis. Long-Term Results After Treatment With Either Low-Molecular -Weight Heparin or Unfractionated Heparin. Examinations of the Venous System.
- ClinicalTrials.gov ID
- NCT00628576
- Acronym / sponsor ID
- VN 2003/15 (2-16-4 - 0001- 03)
- Conditions
- Deep Venous Thrombosis
- Keywords
- Deep Venous Thrombosis, lower extremities, Chronic Venous Insufficiency, Postthrombotic Syndrome, Heparins, Low-molecular- weight heparin, Tinzaparin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Collaborators
- Aalborg University
- Study start
- Oct 1993
- Primary completion
- Jun 2004 (actual)
- Study completion
- Jun 2004 (actual)
- First posted
- 5 Mar 2008 (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 purpose of the study was to evaluate efficacy and safety of the new acute treatment of deep venous thrombosis by use of low-molecular-weight heparin compared with standard treatment using unfractionated heparin, especially concerning long-term morbidity.
Detailed description
Deep-venous thrombosis (DVT) remains a common clinical problem (annual incidence 0.10-0.16%) and long-term morbidity as chronic venous insufficience (CVI) in 10-30%.
As to recurrent DVT, initial treatment with Low-Molecular-Weight Heparin ( to-day's terminology Fractionated Heparin (FH)) and Unfractionated Heparin (UFH) has shown equal efficiency, whereas the efficacy concerning long-term morbidity has only more recently been published.
This study was initiated to compare the efficacy of UFH and FH concerning the incidence of CVI after symptomatic DVT at short-term and long-term follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: unfractionated heparinUFH: patients treated with unfractionated heparin |
| 2 | Experimental | Drug: Tinzaparin (Leo)FH: patients treated with low-molecular-weight (fractionated) heparin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- First DVT with or without known risk factors except overt cancer
- Second DVT more than two years after the first if the patient was without clinical signs of CVI.
Key exclusion criteria (4 listed)
- Contraindication to anticoagulation therapy
- Candidate to thrombectomy with arterious-venous fistula or thrombolytic therapy
- Known cancer at the time of the DVT diagnosis
- Patients unable to cooperate for anticoagulation therapy or manage the tests.
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 |
|---|---|---|
| unfractionated heparinAlso: Heparin SAD 1000 IU/mlUFH: Continuous i.v. infusion 100 IU/kg/4hrs initially and then adjusted to maintain APTT value 1.5 - 2.5 the pre-treatment value | Drug | 1 |
| Tinzaparin (Leo)Also: Innohep (Leo)FH (Tinzaparin): 175 iu/kg s.c. in the abdomen once daily | Drug | 2 |
Primary outcome
Clinical evaluation of chronic venous insufficiency (CVI) - (Postthrombotic Syndrome) based on internationally accepted criteria.
Time frame: Two years and 6 to 10 years
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 5 Mar 2008.
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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.
Benedicte Laursen, MD, DMSc principal investigator
Department of Haematology; Aalborg Hospital, 9100 Aalborg, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing unfractionated heparin and Tinzaparin (Leo) in people with Deep Venous Thrombosis, run by Aalborg University Hospital at 1 site in Denmark.
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 2 inclusion and 4 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 5 Mar 2008. 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 Denmark. 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.
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?
Clinical evaluation of chronic venous insufficiency (CVI) - (Postthrombotic Syndrome) based on internationally accepted criteria. (time frame: Two years and 6 to 10 years). 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 5 Mar 2008.