A PHASE 2, RANDOMIZED, OPEN-LABEL (WITH BLINDED PLASMINOGEN ACTIVATOR AND PLACEBO CONTROL GROUPS) STUDY TO EVALUATE THE EFFECTS OF DIFFERENT INTRA-THROMBUS INFUSION REGIMENS OF PLASMIN (HUMAN) COMPARED TO PLASMINOGEN ACTIVATOR AND PLACEBO IN PATIENTS WITH ACUTE LOWER EXTREMITY NATIVE ARTERY OR BYPASS GRAFT OCCLUSIO

TALECRIS BIOTHERAPEUTICS, INC,0 个研究点目标入组 5 人开始时间: 2011年2月18日最近更新: 2023年9月4日

适应症

试验速览

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•Unilateral limb ischemia: symptomatic. Categories I and IIa of Acute Ischemia SCV
•onset of symptoms <14 days
•Infrainguinal graft (synthetic mixed, autologous or one outlet) thrombosed (non-embolic) or infrainguinal native artery. In the case of native arteries, occlusions of> 10cm in length are eligible.
•Diagnosis of thrombus with occlusion in the graft or artery by means of an arteriography after informed consent has been obtained
•Ability to access the thrombus with the infusion catheter and successfully insert the infusion segment of the infusion catheter.
•The subject must be able to sign their informed consent before participating in the study.
•Age> 18 years
•In the case of women of childbearing age, they must use an appropriate method of contraception during the study period and must have a negative pregnancy outcome before participating in the study.

•Any medical or social condition that may interfere with the completion of the study by the subject.
•Pregnant or nursing women, or who are in the first 10 days of postpartum.
•Cardiopulmonary resuscitation in the previous year
•Previous systemic or anaphylactoid allergies to contrast agent, streptokinase or blood components (those allergic to shellfish or iodine may enter the study).
•Not eligible for thrombolytic treatment for any reason
•Active graft infection
•Occlusion occurred within the first month of placement of the synthetic graft
•Occlusion occurred within the first six months of autologous graft placement
•A sequential mixed dual-exit graft to correct multiple occlusions
•In the opinion of the Researcher, he is clinically unable to tolerate an open vascular procedure
•History of prothrombotic state, such as anticardiopillin antibody, peripheral vascular disease associated with acquired immunodeficiency virus (HIV)
•History of contraindication to heparin (eg, history of heparin-induced thrombocytopenia)
•Hemoglobin <10.0 g / dl (if the selection shows low hemoglobin with no active bleeding, this can be corrected by transfusion). The hemoglobin test can be taken again.
•Impaired renal function or renal disease that constitutes a contraindication to contrast arteriography, including a creatinine level> 2.0 mg / dL in the baseline selection / evaluation. The creatinine test can be taken again after hydration by prerenal azotemia.

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