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Treatment for Blood Clots in the Veins of the Legs
This study has been completed.
Sponsored by: National Institutes of Health Clinical Center (CC)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00001713
  Purpose

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.


Condition Intervention Phase
Embolism
Thrombophlebitis
Drug: Recombinant Tissue Plasminogen Activator
Drug: Heparin
Drug: Warfarin
Phase I

MedlinePlus related topics: Blood Thinners Deep Vein Thrombosis
Drug Information available for: Warfarin Warfarin potassium Warfarin sodium Heparin Alteplase Tissue-type plasminogen activator
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Safety 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

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 20
Study Start Date: February 1998
Estimated Study Completion Date: January 2006
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA:

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.

EXCLUSION CRITERIA:

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00001713

Locations
United States, Maryland
National Institutes of Health Clinical Center (CC)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Publications:
Study ID Numbers: 980067, 98-CC-0067
Study First Received: November 3, 1999
Last Updated: March 3, 2008
ClinicalTrials.gov Identifier: NCT00001713  
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
rtPA
Catheter Directed
Thrombolysis
Anticoagulation
Emboli
Acute Deep Venous Thrombosis
TPA
DVT

Study placed in the following topic categories:
Peripheral Vascular Diseases
Vasculitis
Vascular Diseases
Tissue Plasminogen Activator
Warfarin
Thrombosis
Calcium heparin
Embolism and Thrombosis
Embolism
Phlebitis
Venous Thrombosis
Plasminogen
Heparin
Thrombophlebitis

Additional relevant MeSH terms:
Fibrin Modulating Agents
Anticoagulants
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Hematologic Agents
Fibrinolytic Agents
Cardiovascular Diseases
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009