Protocol Number: 04-CC-0178
Patients 18 years of age and older who have blood clots in a deep vein of the pelvis or leg may be eligible for this study if they have had symptoms for 14 days or less and if they have never had clots in their deep veins before. Participants are admitted to hospital for 3 to 5 days. On the first treatment day, the patient has a venogram to show the location of the clots. The radiologist injects an x-ray contrast material into a small vein in the foot and watches the dye by x-ray as it moves up the leg, revealing the clot(s). A catheter (plastic tube) is then inserted into a vein either behind the knee, in the groin, or in the neck, and advanced until it reaches the clots. When the catheter is in place, rtPA is injected while the radiologist watches the vein under the x-ray image. The amount of rtPa needed will depends on the size of the clot. Up to five venograms may be done if the clot requires the maximum four rtPA treatments allowed in this study. During the treatments, patients receive standard doses of heparin, given continuously by vein, and Coumadin, another blood thinner, taken by mouth. Patients continue taking Coumadin for 6 months. Blood samples are drawn shortly before the first dose of rtPa and at five time points afterward to measure the rtPa in the circulation and other factors that indicate whether the rtPa is affecting clotting ability. Blood also is drawn at least once a day to monitor heparin levels. To evaluate the impact of treatment on the function of the leg, patients are evaluated in the Rehabilitation Medicine Department before receiving rtPA and again at the end of the hospitalization. Patients are also fitted for a compression stocking for the leg, which should be worn to reduce the chance of swelling.
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National Institutes of Health Clinical Center
Bethesda, Maryland 20892. Last update: 01/30/2009
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