Deep Vein ThrombosisNCT00266045
D-dimer Levels During and After Anticoagulation in Patients With a Previous Venous Thromboembolism: Effects on the Risk of Recurrence
An observational study of Deep Vein Thrombosis and Pulmonary Embolism, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
The results of the Prolong study, currently submitted for publication, show that patients with a first unprovoked venous thromboembolic event who have altered D-dimer levels, measured one month after anticoagulation with vitamin K antagonists is stopped, have a high rate of recurrences (about 14%) and a prolongation… Read more about this study
- Who is it for?
- Ages 18 to 82 years
- Conditions the study is for
- Deep Vein Thrombosis, Pulmonary Embolism
- How many people
- 355 participants
- Where
- 1 siteItaly
- Study dates
- Aug 2005to Dec 2008
- Phase
- Observational
- 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 to 82 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with a single previous idiopathic venous thromboembolic event who stop anticoagulation
Who may be able to join
- Age > 18 years
- After a first documented idiopathic proximal deep vein thrombosis and/or pulmonary embolism
- After at least 6 months of oral anticoagulation
- After written informed consent
Who cannot join
- Age > 82 y
- Recurrent venous thromboembolism
- If the Venous thromboembolism occurred:
- during pregnancy or puerperium
- after recent (i.e. within three months) fracture or plaster casting of a leg,
- after immobilization with confinement to bed for three consecutive days after surgery with general anesthesia lasting longer than 30 minutes
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- Patients with:
- active cancer
- antiphospholipid antibody syndrome
- antithrombin deficiency
- serious liver disease or renal insufficiency (creatininemia > 2 mg/dL),
- other indications for anticoagulation or contraindications for this treatment
- limited life expectation
- Patients who live too far from the clinical center
Trial locations and contacts
1 site in 1 country.
Italy1 site
Dept. Angiology & Blood Coagulation; Azienda Ospedaliero-Universitaria di Bologna, Policlinico S. Orsola-Malpighi
Bologna, BO, 40138
About this study
Official title: A Multicentre, Prospective, Observational Study on the Predictive Role for Recurrence of D-dimer Levels Measured During and After Anticoagulation in Patients With a First Venous Thromboembolism Episode (the PROLONG-II Study)
The results of the Prolong study, currently submitted for publication, show that patients with a first unprovoked venous thromboembolic event who have altered D-dimer levels, measured one month after anticoagulation with vitamin K antagonists is stopped, have a high rate of recurrences (about 14%) and a prolongation of anticoagulation is effective in reducing significantly this rate. Those patients with normal D-dimer (about 60% of all patients examined) have a low rate of recurrences (about 5%) and likely a prolongation of anticoagulation in all these patients cannot be recommended.
In line with these results, the Prolong-Two study aims at assessing the predictive role for recurrence of D-dimer levels measured: a) during anticoagulation, b) one month after its withdrawal and c) periodically during follow up.
Patients with a first unprovoked venous thromboembolism (including proximal deep vein thrombosis of a leg and/or pulmonary embolism) which are treated with vitamin K antagonists for not less than 6 months are considered for the study. D-dimer assay is performed during anticoagulation and patients with altered results continue the anticoagulation for 6 more months. Those with normal D-dimer stop the anticoagulant treatment and are again examined one month later. Anticoagulation is resumed for 6 more months in those patients with abnormal D-dimer results but is permanently stopped in those with a normal assay. The latter patients are examined and D-dimer assay performed again every two months to evaluate the natural history of the assay after anticoagulation is stopped and the possible predictive value for recurrence of a change of the assay during follow-up from normal to abnormal results.
- Conditions
- Deep Vein Thrombosis, Pulmonary Embolism
- Keywords
- Deep Vein Thrombosis, Pulmonary Embolism, D-dimer, Recurrence, Duration of Anticoagulation, Vitamin K Antagonists
- Medical subject headings
- Venous Thrombosis, Pulmonary Embolism, Recurrence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2005 (estimated)
- Study startAug 2005
- Primary completionJun 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Deep Vein 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 355 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Sponsor type
- University, hospital or other
- Collaborators
- Italian Federation of Anticoagulation Clinics (FCSA)
- Responsible party
- Principal investigator, GUALTIERO PALARETI, IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Investigators
- Gualtiero Palareti, MD, Study chair, Dept. Angiology & Blood Coagulation, University Hospital S. Orsola-Malpighi, Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00266045
- Sponsor's protocol ID
- PROLONG-TWO STUDY
- Status last verified
- Mar 2021
- First submitted
- 13 Dec 2005
- Last updated
- 19 Mar 2021
- Results posted
- No
Publications
Cosmi B, Legnani C, Pengo V, Ghirarduzzi A, Testa S, Poli D, Prisco D, Tripodi A, Palareti G; PROLONG Investigators (on behalf of FCSA, Italian Federation of Anticoagulation Clinics). The influence of factor V Leiden and G20210A prothrombin mutation on the presence of residual vein obstruction after idiopathic deep-vein thrombosis of the lower limbs. Thromb Haemost. 2013 Mar;109(3):510-6. doi: 10.1160/TH12-01-0041. Epub 2013 Jan 10.
PubMed 23306310Cosmi B, Legnani C, Tosetto A, Pengo V, Ghirarduzzi A, Testa S, Prisco D, Poli D, Tripodi A, Marongiu F, Palareti G; PROLONG Investigators (on behalf of Italian Federation of Anticoagulation Clinics). Usefulness of repeated D-dimer testing after stopping anticoagulation for a first episode of unprovoked venous thromboembolism: the PROLONG II prospective study. Blood. 2010 Jan 21;115(3):481-8. doi: 10.1182/blood-2009-08-237354. Epub 2009 Nov 16.
PubMed 19965693Palareti G, Cosmi B, Legnani C. D-dimer testing to determine the duration of anticoagulant therapy. Curr Opin Pulm Med. 2007 Sep;13(5):393-7. doi: 10.1097/MCP.0b013e3282058b94.
PubMed 17940483
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
- A Multicentre, Prospective, Observational Study on the Predictive Role for Recurrence of D-dimer Levels Measured During and After Anticoagulation in Patients With a First Venous Thromboembolism Episode (the PROLONG-II Study)
- ClinicalTrials.gov ID
- NCT00266045
- Acronym / sponsor ID
- PROLONG-TWO STUDY
- Conditions
- Deep Vein Thrombosis, Pulmonary Embolism
- Keywords
- Deep Vein Thrombosis, Pulmonary Embolism, D-dimer, Recurrence, Duration of Anticoagulation, Vitamin K Antagonists
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 355 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Collaborators
- Italian Federation of Anticoagulation Clinics (FCSA)
- Study start
- Aug 2005
- Primary completion
- Jun 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 15 Dec 2005 (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 results of the Prolong study, currently submitted for publication, show that patients with a first unprovoked venous thromboembolic event who have altered D-dimer levels, measured one month after anticoagulation with vitamin K antagonists is stopped, have a high rate of recurrences (about 14%) and a prolongation of anticoagulation is effective in reducing significantly this rate. Those patients with normal D-dimer (about 60% of all patients examined) have a low rate of recurrences (about 5%) and likely a prolongation of anticoagulation in all these patients cannot be recommended.
In line with these results, the Prolong-Two study aims at assessing the predictive role for recurrence of D-dimer levels measured: a) during anticoagulation, b) one month after its withdrawal and c) periodically during follow up.
Patients with a first unprovoked venous thromboembolism (including proximal deep vein thrombosis of a leg and/or pulmonary embolism) which are treated with vitamin K antagonists for not less than 6 months are considered for the study. D-dimer assay is performed during anticoagulation and patients with altered results continue the anticoagulation for 6 more months. Those with normal D-dimer stop the anticoagulant treatment and are again examined one month later. Anticoagulation is resumed for 6 more months in those patients with abnormal D-dimer results but is permanently stopped in those with a normal assay. The latter patients are examined and D-dimer assay performed again every two months to evaluate the natural history of the assay after anticoagulation is stopped and the possible predictive value for recurrence of a change of the assay during follow-up from normal to abnormal results.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 82 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with a single previous idiopathic venous thromboembolic event who stop anticoagulation
Key inclusion criteria (4 listed)
- Age > 18 years
- After a first documented idiopathic proximal deep vein thrombosis and/or pulmonary embolism
- After at least 6 months of oral anticoagulation
- After written informed consent
Key exclusion criteria (14 listed)
- Age > 82 y
- Recurrent venous thromboembolism
- If the Venous thromboembolism occurred:
- during pregnancy or puerperium
- after recent (i.e. within three months) fracture or plaster casting of a leg,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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.
- Derived from this study: PubMed 23306310Cosmi B, Legnani C, Pengo V, Ghirarduzzi A, Testa S, Poli D, Prisco D, Tripodi A, Palareti G; PROLONG Investigators (on behalf of FCSA, Italian Federation of Anticoagulation Clinics). The influence of factor V Leiden and G20210A prothrombin mutation on the presence of residual vein obstruction after idiopathic deep-vein thrombosis of the lower limbs. Thromb Haemost. 2013 Mar;109(3):510-6. doi: 10.1160/TH12-01-0041. Epub 2013 Jan 10.
- Derived from this study: PubMed 19965693Cosmi B, Legnani C, Tosetto A, Pengo V, Ghirarduzzi A, Testa S, Prisco D, Poli D, Tripodi A, Marongiu F, Palareti G; PROLONG Investigators (on behalf of Italian Federation of Anticoagulation Clinics). Usefulness of repeated D-dimer testing after stopping anticoagulation for a first episode of unprovoked venous thromboembolism: the PROLONG II prospective study. Blood. 2010 Jan 21;115(3):481-8. doi: 10.1182/blood-2009-08-237354. Epub 2009 Nov 16.
- Derived from this study: PubMed 17940483Palareti G, Cosmi B, Legnani C. D-dimer testing to determine the duration of anticoagulant therapy. Curr Opin Pulm Med. 2007 Sep;13(5):393-7. doi: 10.1097/MCP.0b013e3282058b94.
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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.
Gualtiero Palareti, MD study chair
Dept. Angiology & Blood Coagulation, University Hospital S. Orsola-Malpighi, Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Deep Vein Thrombosis and Pulmonary Embolism, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site 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 14 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 1 site 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. 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?
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00266045, which also lists 3 linked publications.
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; AzTrials last refreshed its copy on 26 Oct 2026.