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NESVS Subclavian Vein Thrombosis Protocol
Over a year ago, a group consisting of Drs. Arous, Gertler, Jorgensen, Walsh and Donaldson met to put together a clinical research protocol for management of patients with acute primary subclavian vein thrombosis (Paget-Schroetter syndrome, effort thrombosis). The protocol is aimed at candidates suitable for a relatively aggressive interventional approach based upon recent methods and results reported in the literature. We did not include patients with chronic occlusion nor those who would be best managed conservatively on the basis of low symptom severity or high risk for intervention. After some discussion, the group agreed on a scheme utilizing early radiologic diagnosis and catheter-based thrombolysis, surgical decompression of the thoracic inlet at the same hospitalization, postoperative percutaneous angioplasty when appropriate, oral anticoagulation, followup venography and duplex ultrasound with selected intervention for residual or recurrent intrinsic vein stenosis. Since beginning this project on a trial basis a year ago, we have accrued a small number of patients sufficient to feel confident that this protocol is feasible and likely to be fruitful.
At this stage, we would like to enlist participation from interested members of the New England Society for Vascular Surgery in order to enhance patient enrolment and data accrual. In addition, since this project involving a relatively rare disorder is likely best studied by regional collaboration, the NESVS is a particularly appropriate conduit. If successful, the project may be a valuable prototype for other clinical research under the unofficial umbrella of the NESVS.The original instigators have volunteered to serve as an unofficial Steering Committee. The NESVS will have no official role in the project other than through activities of its members who participate. Each participant will be expected to clear the protocol with his own institution and colleagues in radiology and surgery, and to adhere to the procedures including accurate and timely gathering and reporting of study data. Data monitoring, analysis and presentation will be coordinated by the Steering Committee with participation of any others who are interested, with collegial group authorship if we get that far. No funds will change hands. A copy of the protocol can be obtained from Dr. Donaldson.