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Patients with Leg Blood Clots Sought for Clinical Study

Washington University interventional radiologists are seeking participants for a study comparing two treatments for deep vein thromboses (DVTs).

Post-thrombotic syndrome (PTS) is a serious long-term complication of DVT and occurs in 25 percent to 50 percent of DVT patients despite conventional treatment. PTS causes chronic leg pain, swelling and difficulty walking, and it sometimes progresses to open sores on the leg. Conventional treatment with bloodthinning drugs can prevent clot migration and new clot formation but does not actively break up the original clot, which ultimately damages the leg veins and leads to PTS.

The multicenter ATTRACT (Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis) Trial will test the ability of catheter-based methods of dissolving blood clots to prevent the post-thrombotic syndrome and improve quality of life in patients with DVT. The catheter-based treatment includes the injection of the clot-busting drug tissue plasminogen activator directly into the blood clot. While this is believed to remove the clot and reduce the long-term risk of PTS, excessive bleeding is a potential risk.

The purpose of the study is to determine whether using this new clot-dissolving technology as a first-line treatment for DVTs along with conventional blood-thinning drugs provides better outcomes than bloodthinning drugs alone.

Researchers are seeking to enroll 50 participants into the St. Louis portion of the study. They can enroll patients within two weeks of DVT diagnosis. Participants accepted for the two-year trial will be randomly assigned to receive conventional treatment with or without the catheter-based treatment and may be responsible for treatment costs not covered by their insurance or Medicare.

Suresh Vedantham, MD, a Washington University interventional radiologist within the school’s Mallinckrodt Institute of Radiology, is the national principal investigator for the trial.

“This is the first large-scale test of these techniques,” says Vedantham. “If the trial is positive, it will alter the paradigm to say we don’t just prevent the next clot, we’ve got to also remove the existing clot first.”

The $10 million trial is funded by the National Heart, Lung and Blood Institute, part of the National Institutes of Health.

For more information, call 1-866-974-CLOT (2568) or visit www.attract.wustl.edu.

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