EmbolismPhase 1NCT00001713
Treatment for Blood Clots in the Veins of the Legs
A Phase 1 study testing Recombinant Tissue Plasminogen Activator, Heparin and Warfarin in people with Embolism and Thrombophlebitis, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial summary
Acute deep venous thrombosis (ADVT) of the lower extremity is a common disorder. Traditional treatment with anticoagulation therapy is effective in reducing the associated risk of pulmonary embolism, but is ineffective in restoring patency of the venous system of the lower extremity. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Embolism, Thrombophlebitis
- What is being tested?
- Recombinant Tissue Plasminogen Activator, Heparin and Warfarin
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 1998to Jan 2006
- Phase
- Phase 1
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must be 18 years or older. A negative pregnancy test is required for all female patients of child-bearing age.
- Only patients with first onset acute DVT will be accepted. Acute DVT-LE must be documented by ultrasonography or venogram and will be defined as thrombosis of a major deep vein segment above the popliteal vein less than 14 days since onset of symptoms or diagnosis. Extension of thrombosis from the popliteal vein into calf veins is acceptable, but isolated calf vein thrombosis will not be treated under this protocol, as the benefits of thrombolytic therapy do not outweigh the risks.
Who cannot join
- Current familial or acquired bleeding diathesis not attributable to heparin (prothrombin time greater than 15 s, a PTT greater than 36 s, fibrinogen less than 150 mg/dL); platelet count less than 50,000/gL unsupportable with platelet transfusions; creatinine greater than 2 mg/dL; severe hypertension (systolic greater than 200 mm Hg, or diastolic greater than 100 mm Hg); atrial fibrillation; known right-to-left shunts; pregnancy; breast feeding; history of anaphylactic reactions to contrast media; history or evidence of heparin-induced thrombocytopenia. Patients with underlying coagulopathy must be evaluated and cleared by Dr. Horne or a consulting NIH hematologist before they can be accepted for the treatment protocol.
- Any of the following within the previous 2 weeks: gastrointestinal hemorrhage, active peptic ulcer disease, hemoptysis, genitourinary tract hemorrhage (except microscopic hematuria), major surgery, trauma, or biopsy of a non-compressible site.
- Any of the following within the previous 2 months: cerebrovascular accident or hemorrhage.
- Patients with hematocrits less than 30 percent or hemoglobin's less than 19 g/dl, based on Clinical Center testing will not be asked to participate in the Thrombolytic Enzyme Kinetic Study.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center (CC)
Bethesda, Maryland, 20892
About this study
Official title: Treatment of Acute Deep Vein Thrombosis of the Lower Extremity With Intraclot, Pulse-Sprayed Recombinant Tissue Plasminogen Activator, Plus Heparin and Warfarin: A Pilot Study
Acute deep venous thrombosis (ADVT) of the lower extremity is a common disorder. Traditional treatment with anticoagulation therapy is effective in reducing the associated risk of pulmonary embolism, but is ineffective in restoring patency of the venous system of the lower extremity. While systemic thrombolytic therapy has been shown to be more effective than anticoagulation, catheter directed local thrombolytic therapy is the most effective treatment in restoring venous patency. Current treatment regimens are based on use of urokinase, infused continuously through catheters imbedded into the thrombus. These treatment regimens require doses on the order of 10,000,000 units of urokinase, resulting in significant bleeding complications and prohibitive costs.
Experience at NIH with pulse-spray treatment of axillary subclavian venous thrombosis with rtPA indicates that this is a highly effective and safe alternative thrombolytic regimen. The proposed protocol is designed to evaluate the efficiency, safety, and doses of rtPA associated with pulse spray directed rtPA treatment of the more extensive venous thrombosis encountered in the lower extremity.
Read the detailed description
Acute deep venous thrombosis (ADVT) of the lower extremity is a common disorder. Traditional treatment with anticoagulation therapy is effective in reducing the associated risk of pulmonary embolism, but is ineffective in restoring patency of the venous system of the lower extremity. While systemic thrombolytic therapy has been shown to be more effective than anticoagulation, catheter directed local thrombolytic therapy is the most effective treatment in restoring venous patency. Current treatment regimens are based on use of urokinase, infused continuously through catheters imbedded into the thrombus. These treatment regimens require doses on the order of 10,000,000 units of urokinase, resulting in significant bleeding complications and prohibitive costs.
Experience at NIH with pulse-spray treatment of axillary subclavian venous thrombosis with rtPA indicates that this is a highly effective and safe alternative thrombolytic regimen. The proposed protocol is designed to evaluate the efficiency, safety, and doses of rtPA associated with pulse spray directed rtPA treatment of the more extensive venous thrombosis encountered in the lower extremity.
- Conditions
- Embolism, Thrombophlebitis
- Being tested
- Recombinant Tissue Plasminogen Activator, Heparin, Warfarin
- Keywords
- rtPA, Catheter Directed, Thrombolysis, Anticoagulation, Emboli, Acute Deep Venous Thrombosis, TPA, DVT
- Medical subject headings
- Embolism, Thrombophlebitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Tissue Plasminogen ActivatorDrug
HeparinDrug
WarfarinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study startFeb 1998
- Study completionJan 2006
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 EmbolismStudies 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 1
- Primary purpose
- Treatment
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001713
- Sponsor's protocol ID
- 980067
- Other IDs
- 98-CC-0067
- Status last verified
- Jan 2006
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Semba CP, Dake MD. Iliofemoral deep venous thrombosis: aggressive therapy with catheter-directed thrombolysis. Radiology. 1994 May;191(2):487-94. doi: 10.1148/radiology.191.2.8153327.
PubMed 8153327Chang R, Horne MK 3rd, Mayo DJ, Doppman JL. Pulse-spray treatment of subclavian and jugular venous thrombi with recombinant tissue plasminogen activator. J Vasc Interv Radiol. 1996 Nov-Dec;7(6):845-51. doi: 10.1016/s1051-0443(96)70858-8.
PubMed 8951751Thrombolytic therapy in thrombosis: a National Institutes of Health consensus development conference. Ann Intern Med. 1980 Jul;93(1):141-4. doi: 10.7326/0003-4819-93-1-141. No abstract available.
PubMed 7396293
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Acute Deep Vein Thrombosis of the Lower Extremity With Intraclot, Pulse-Sprayed Recombinant Tissue Plasminogen Activator, Plus Heparin and Warfarin: A Pilot Study
- ClinicalTrials.gov ID
- NCT00001713
- Acronym / sponsor ID
- 980067
- Conditions
- Embolism, Thrombophlebitis
- Keywords
- rtPA, Catheter Directed, Thrombolysis, Anticoagulation, Emboli, Acute Deep Venous Thrombosis, TPA, DVT
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- Feb 1998
- Study completion
- Jan 2006
- First posted
- 4 Nov 1999 (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.
Acute deep venous thrombosis (ADVT) of the lower extremity is a common disorder. Traditional treatment with anticoagulation therapy is effective in reducing the associated risk of pulmonary embolism, but is ineffective in restoring patency of the venous system of the lower extremity. While systemic thrombolytic therapy has been shown to be more effective than anticoagulation, catheter directed local thrombolytic therapy is the most effective treatment in restoring venous patency. Current treatment regimens are based on use of urokinase, infused continuously through catheters imbedded into the thrombus. These treatment regimens require doses on the order of 10,000,000 units of urokinase, resulting in significant bleeding complications and prohibitive costs.
Experience at NIH with pulse-spray treatment of axillary subclavian venous thrombosis with rtPA indicates that this is a highly effective and safe alternative thrombolytic regimen. The proposed protocol is designed to evaluate the efficiency, safety, and doses of rtPA associated with pulse spray directed rtPA treatment of the more extensive venous thrombosis encountered in the lower extremity.
Detailed description
Acute deep venous thrombosis (ADVT) of the lower extremity is a common disorder. Traditional treatment with anticoagulation therapy is effective in reducing the associated risk of pulmonary embolism, but is ineffective in restoring patency of the venous system of the lower extremity. While systemic thrombolytic therapy has been shown to be more effective than anticoagulation, catheter directed local thrombolytic therapy is the most effective treatment in restoring venous patency. Current treatment regimens are based on use of urokinase, infused continuously through catheters imbedded into the thrombus. These treatment regimens require doses on the order of 10,000,000 units of urokinase, resulting in significant bleeding complications and prohibitive costs.
Experience at NIH with pulse-spray treatment of axillary subclavian venous thrombosis with rtPA indicates that this is a highly effective and safe alternative thrombolytic regimen. The proposed protocol is designed to evaluate the efficiency, safety, and doses of rtPA associated with pulse spray directed rtPA treatment of the more extensive venous thrombosis encountered in the lower extremity.
Study design
- Primary purpose
- Treatment
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients must be 18 years or older. A negative pregnancy test is required for all female patients of child-bearing age.
- Only patients with first onset acute DVT will be accepted. Acute DVT-LE must be documented by ultrasonography or venogram and will be defined as thrombosis of a major deep vein segment above the popliteal vein less than 14 days since onset of symptoms or diagnosis. Extension of thrombosis from the popliteal vein into calf veins is acceptable, but isolated calf vein thrombosis will not be treated under this protocol, as the benefits of thrombolytic therapy do not outweigh the risks.
Key exclusion criteria (4 listed)
- Current familial or acquired bleeding diathesis not attributable to heparin (prothrombin time greater than 15 s, a PTT greater than 36 s, fibrinogen less than 150 mg/dL); platelet count less than 50,000/gL unsupportable with platelet transfusions; creatinine greater than 2 mg/dL; severe hypertension (systolic greater than 200 mm Hg, or diastolic greater than 100 mm Hg); atrial fibrillation; known right-to-left shunts; pregnancy; breast feeding; history of anaphylactic reactions to contrast media; history or evidence of heparin-induced thrombocytopenia. Patients with underlying coagulopathy must be evaluated and cleared by Dr. Horne or a consulting NIH hematologist before they can be accepted for the treatment protocol.
- Any of the following within the previous 2 weeks: gastrointestinal hemorrhage, active peptic ulcer disease, hemoptysis, genitourinary tract hemorrhage (except microscopic hematuria), major surgery, trauma, or biopsy of a non-compressible site.
- Any of the following within the previous 2 months: cerebrovascular accident or hemorrhage.
- Patients with hematocrits less than 30 percent or hemoglobin's less than 19 g/dl, based on Clinical Center testing will not be asked to participate in the Thrombolytic Enzyme Kinetic Study.
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 |
|---|---|---|
| Recombinant Tissue Plasminogen Activator | Drug | – |
| Heparin | Drug | – |
| Warfarin | Drug | – |
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 4 Mar 2008.
- Background: PubMed 8153327Semba CP, Dake MD. Iliofemoral deep venous thrombosis: aggressive therapy with catheter-directed thrombolysis. Radiology. 1994 May;191(2):487-94. doi: 10.1148/radiology.191.2.8153327.
- Background: PubMed 8951751Chang R, Horne MK 3rd, Mayo DJ, Doppman JL. Pulse-spray treatment of subclavian and jugular venous thrombi with recombinant tissue plasminogen activator. J Vasc Interv Radiol. 1996 Nov-Dec;7(6):845-51. doi: 10.1016/s1051-0443(96)70858-8.
- Background: PubMed 7396293Thrombolytic therapy in thrombosis: a National Institutes of Health consensus development conference. Ann Intern Med. 1980 Jul;93(1):141-4. doi: 10.7326/0003-4819-93-1-141. No abstract available.
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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 Phase 1 study testing Recombinant Tissue Plasminogen Activator, Heparin and Warfarin in people with Embolism and Thrombophlebitis, run by National Institutes of Health Clinical Center (CC) at 1 site 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 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 4 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 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001713, 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 4 Mar 2008.