Status:
COMPLETED
Low-Dose Alteplase to Treat Blood Clots in Deep Leg Veins
Lead Sponsor:
Richard Chang, M.D.
Collaborating Sponsors:
National Institutes of Health Clinical Center (CC)
Conditions:
Acute Deep Venous Thrombosis of the Lower Extremity
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study will test the effectiveness of low-dose recombinant tissue plasminogen activator (rtPA, or alteplase) in dissolving blood clots in deep leg veins. Alteplase is used to clear blood clots in ...
Detailed Description
Deep venous thrombosis (DVT) of the lower extremities is routinely treated with anticoagulants, which is very effective in preventing pulmonary embolism, but does not reliably restore venous function ...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA
- Only adult patients (18 years old or older) are included.
- Patients must have thrombosis documented by ultrasound or venography to involve the deep veins of the pelvis and/or a lower extremity proximal to the calf veins, i.e., the popliteal vein or above.
- The thrombosis must be the patient's first DVT.
- The thrombosis must have been symptomatic for no more than 14 days.
- Patients must be able to give informed consent and be able to follow the prescribed anticoagulation regimen.
- Patients on concurrent NIH protocols will be eligible as well as patients from the community and the rest of the U.S. who are not already on NIH protocols.
- EXCLUSION CRITERIA
- Pregnant patients are not eligible, although postpartum mothers over 10 days from delivery are eligible if they refrain from breast feeding their infants for 24 hours after each study with x-ray contrast material.
- Serum creatinine greater than than 2 mg/dL.
- Any current bleeding diathesis not attributable to heparin or warfarin. Fibrinogen less than 150 mg/dL. Any patient with a prothrombin time (PTT) greater than 15 s, an activated partial thromboplastin time (aPTT) greater than 35 s, or a platelet count less than 100,000/microliter must be evaluated by the Hematology Service for a coagulopathy before being included.
- Within the previous 10 days: major surgery or trauma, puncture of a noncompressible vessel, organ biopsy, or cardiopulmonary resuscitation.
- Within the previous 2 months: cerebrovascular infarction or hemorrhage, or intracranial or intraspinal surgery or trauma.
- Within the previous 6 months: major internal bleeding.
- Active intracranial disease (aneurysm, vascular malformation, neoplasm).
- Life expectancy less than 6 months.
- Patients with hemoglobin concentration less than 9g/dL will not participate in the pharmacokinetic portion of the protocol.
- Uncontrolled systolic blood pressure greater than 180 mm Hg or diastolic greater than 100 mm Hg.
- Atrial fibrillation, unless a cardiac echocardiogram excludes the presence of intracardiac thrombus.
- Known right-to-left intracardiac shunt.
- Pericarditis, infective endocarditis.
- History of heparin-induced thrombocytopenia within 6 months or the presence of persistent anti-heparin antibodies by ELISA.
- History of anaphylactic reactions to x-ray contrast media.
- Known retinopathy unless cleared by an ophthalmologist at NIH.Evidence of uncontrolled congestive heart failure or a history of diabetes mellitus.
Exclusion
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00082355
Start Date
May 1 2004
End Date
October 1 2014
Last Update
November 6 2014
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892