Deep-Vein ThrombosisPhase 4NCT00245856
Treatment of Upper Extremity Deep-Vein Thrombosis
A Phase 4 study testing Dalteparin sodium injection and Warfarin in people with Deep-Vein Thrombosis, run by University of Oklahoma at 2 sites in United States.
Trial summary
The purpose of this study is to document the long-term outcome or prognosis of patients diagnosed with upper extremity deep-vein thrombosis who are treated with Fragmin (dalteparin sodium injection) for three months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deep-Vein Thrombosis
- What is being tested?
- Dalteparin sodium injection and Warfarin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2002to Dec 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients with confirmed upper extremity DVT diagnosed by ultrasound imaging or venogram
Who cannot join
- Active, clinically significant bleeding
- Known hypersensitivity to heparin or low-molecular weight heparin
- Currently pregnant or less than 1 week post-partum
- Acquired bleeding diathesis
- Known inherited bleeding disorder
- Renal failure
Show all 9Show fewer
- Extremes of weight
- Poor performance status
- Unable to return for repeat diagnostic testing or follow-up visits
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Department of Veterans Affairs Medical Center
Oklahoma City, Oklahoma, 73104
University of Oklahoma Health Science Center
Oklahoma City, Oklahoma, 73117
About this study
The purpose of this study is to document the long-term outcome or prognosis of patients diagnosed with upper extremity deep-vein thrombosis who are treated with Fragmin (dalteparin sodium injection) for three months.
Read the detailed description
Upper extremity deep-vein thrombosis (DVT) is an increasingly common clinical problem and has been found to cause important pulmonary embolism in up to 36% of cases including fatal embolism. The major risk factor for development of DVT is presence of a central venous catheter in which up to 30% of patients may develop venous thrombosis. Peripherally inserted central catheters or (PICC) lines have been more frequently used in order to avoid the morbidity of central venous catheter insertion. There is little data on the incidence of DVT with these catheters, or effective treatment regimen.
The purpose of this study is to document the long-term outcome or prognosis of patients diagnosed with upper extremity deep-vein thrombosis who are treated with Fragmin (dalteparin sodium injection) for three months. About 100 patients will be enrolled in this study at the University of Oklahoma.
All patients with upper extremity DVT will be screened. Each will have a complete baseline and risk factor assessment.
All patients will receive active study drug for a period of 3 months with reassessment of upper extremity DVT by ultrasound.
All patients will participate for a period of 12 months with follow up visits at 5-7 day, and 1, 3, 6, 12 months.
- Conditions
- Deep-Vein Thrombosis
- Being tested
- Dalteparin sodium injection, Warfarin
- Keywords
- Upper Extremity Deep-Vein Thrombosis, DVT, Fragmin, Deep-Vein Thrombosis, Thrombosis
- Medical subject headings
- Venous Thrombosis, Upper Extremity Deep Vein Thrombosis, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dalteparin sodium injectionDrug
Also called Fragmin
200units/kg subcutaneous daily for one month, followed by 150units/kg subcutaneous daily for two additional months or 200 units/kg subcutaneously daily for 5 days followed by warfarin.
WarfarinDrug
Titrated to INR 2-3 through study month 3
| Study group | Role | What they receive |
|---|---|---|
| Treatment of Upper Extremity DVT | Experimental | Participants received dalterparin followed by warfarin or received dalterparin monotherapy for the treatment of upper extremity DVT Receives: Drug: Dalteparin sodium injection; Drug: Warfarin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants That Died at 3 Months
Measured: 3 months
New Venous Thromboembolism at 3 Months
New DVT or PE at 3 months confirmed by diagnostic testing
Measured: 3 months
Secondary outcomes (1)
Bleeding Events
Total major bleeding rate
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2005 (estimated)
- Study startSep 2002
- Primary completionMar 2009
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Deep-Vein ThrombosisStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, Suman Rathbun, University of Oklahoma
- Investigators
- Suman W. Rathbun, M.D., Principal investigator, University of Oklahoma Health Science Center, Dept of Medicine/CardioVascular section
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00245856
- Sponsor's protocol ID
- 10206
- Other IDs
- ORA-20020622
- Status last verified
- Feb 2013
- First submitted
- 26 Oct 2005
- Last updated
- 21 Feb 2013
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Upper Extremity Deep-Vein Thrombosis
- ClinicalTrials.gov ID
- NCT00245856
- Acronym / sponsor ID
- 10206
- Conditions
- Deep-Vein Thrombosis
- Keywords
- Upper Extremity Deep-Vein Thrombosis, DVT, Fragmin, Deep-Vein Thrombosis, Thrombosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Sep 2002
- Primary completion
- Mar 2009 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 28 Oct 2005 (estimated)
- Results
- Posted 4 Feb 2013
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 this study is to document the long-term outcome or prognosis of patients diagnosed with upper extremity deep-vein thrombosis who are treated with Fragmin (dalteparin sodium injection) for three months.
Detailed description
Upper extremity deep-vein thrombosis (DVT) is an increasingly common clinical problem and has been found to cause important pulmonary embolism in up to 36% of cases including fatal embolism. The major risk factor for development of DVT is presence of a central venous catheter in which up to 30% of patients may develop venous thrombosis. Peripherally inserted central catheters or (PICC) lines have been more frequently used in order to avoid the morbidity of central venous catheter insertion. There is little data on the incidence of DVT with these catheters, or effective treatment regimen.
The purpose of this study is to document the long-term outcome or prognosis of patients diagnosed with upper extremity deep-vein thrombosis who are treated with Fragmin (dalteparin sodium injection) for three months. About 100 patients will be enrolled in this study at the University of Oklahoma.
All patients with upper extremity DVT will be screened. Each will have a complete baseline and risk factor assessment.
All patients will receive active study drug for a period of 3 months with reassessment of upper extremity DVT by ultrasound.
All patients will participate for a period of 12 months with follow up visits at 5-7 day, and 1, 3, 6, 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment of Upper Extremity DVT | Experimental | Drug: Dalteparin sodium injection, Drug: WarfarinParticipants received dalterparin followed by warfarin or received dalterparin monotherapy for the treatment of upper extremity DVT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with confirmed upper extremity DVT diagnosed by ultrasound imaging or venogram
Key exclusion criteria (9 listed)
- Active, clinically significant bleeding
- Known hypersensitivity to heparin or low-molecular weight heparin
- Currently pregnant or less than 1 week post-partum
- Acquired bleeding diathesis
- Known inherited bleeding disorder
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 |
|---|---|---|
| Dalteparin sodium injectionAlso: Fragmin200units/kg subcutaneous daily for one month, followed by 150units/kg subcutaneous daily for two additional months or 200 units/kg subcutaneously daily for 5 days followed by warfarin. | Drug | Treatment of Upper Extremity DVT |
| WarfarinTitrated to INR 2-3 through study month 3 | Drug | Treatment of Upper Extremity DVT |
Primary outcome
Percentage of Participants That Died at 3 Months
Time frame: 3 months
New Venous Thromboembolism at 3 Months
Time frame: 3 months
New DVT or PE at 3 months confirmed by diagnostic testing
1 secondary outcome
Bleeding Events
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Suman W. Rathbun, M.D. principal investigator
University of Oklahoma Health Science Center, Dept of Medicine/CardioVascular section
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dalteparin sodium injection and Warfarin in people with Deep-Vein Thrombosis, run by University of Oklahoma at 2 sites in United States.
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 1 inclusion and 9 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 21 Feb 2013. 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 United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Feb 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants That Died at 3 Months (time frame: 3 months). 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 21 Feb 2013.