EUCTR2010-019760-36-DE进行中（未招募）1 期
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 Occlusion - None
Grifols Therapeutics, Incorporated0 个研究点目标入组 230 人开始时间: 2010年8月2日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 230
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Unilateral limb ischemia: symptomatic, SVS acute ischemic Categories I and IIa
- •2. Onset of symptoms = 14 days
- •3. Thrombosed (non-embolic) infrainguinal graft (synthetic, autologous, or single outflow composite) or infrainguinal native artery. For native arteries, occlusions of = 10 cm in length are eligible.
- •4.Diagnosis of occlusive thrombus
- •a.Diagnosis of occlusive thrombus in the graft or artery by arteriography after informed consent is obtained
- •b.Baseline Arteriogram must show a popliteal artery that is open and filling with contrast within which to place the BOC balloon (only for groups I, J and M)
- •5. Ability to access the thrombus with the infusion catheter and successfully embed the infusion segment of the infusion catheter.
- •6. Subject must be able to give written informed consent prior to study entry
- •7. Age = 18 years
- •8. Women of childbearing potential must use adequate contraception for the duration of the study and must have a negative pregnancy test prior to study entry
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 80
排除标准
- •1. Any medical or social condition that may interfere with the subject successfully completing the study
- •2. Women who are pregnant or lactating, or first 10 days post-partum
- •Past Medical History
- •3. Definitive flow on duplex ultrasound through the occluded segment at baseline
- •4. Cardiopulmonary resuscitation in the last year
- •5. Previous systemic or anaphylactoid allergy to contrast agent, streptokinase, or blood products (subjects allergic to shellfish or iodine are permitted to enter the study).
- •6. Ineligible for thrombolytic treatment for any reason
- •Specific exclusions include: a. History of hemorrhagic stroke, b. Thrombotic or embolic stroke or cerebrovascular events (including transient ischemic attack [TIA]) within the past year, c. Intracranial or spinal neuro-surgery or severe intracranial trauma in the past 3 months, d. Major surgery, organ biopsy, or major trauma within the past 10 days, e. Lumbar puncture or non-compressible arterial puncture in the past 10 days, f. Intra-ocular surgery within the past 10 days, g. Active gastrointestinal or organ bleeding. Minor bleeding such as normal menses, cystitis, or minor hemorrhoidal bleeding are not exclusions, h.Uncontrolled arterial hypertension, defined as a systolic blood pressure >180 millimeters of mercury (mmHg) or diastolic blood pressure >110 mmHg. The subject will be eligible if the hypertension is controlled at the time of study enrollment., i. Known intracranial neoplasm, aneurysm, or arterio-venous malformation, j. Current bleeding diathesis, k. Platelet count <75 x 109/L, l. Subtherapeutic levels of unfractionated heparin anticoagulation as indicated by partial thromboplastin time (aPTT) <50 seconds or activated clotting time (ACT) <300 seconds (subtherapeutic anticoagulation level may be corrected by administration of additional heparin). Testing (aPTT or ACT) may be repeated prior to randomization.
- •7. Active graft infection
- •8. Occlusion occurred within one month of synthetic graft placement.
- •9. Occlusion occurred within 6 months of autologous graft placement
- •10. A sequential composite graft with dual outflows to correct multiple occlusions
- •11. Deemed by the Investigator to be medically unable to tolerate open vascular procedure
- •12. Known prothrombotic state, e.g., anti-cardiolipin antibody, human immunodeficiency virus (HIV)-associated peripheral vascular disease
- •13. Known contraindication to heparin (e.g., history of heparin-induced thrombocytopenia)
- •14. Hemoglobin <10.0 g/dL (low hemoglobin at screening in the absence of active bleeding may be corrected by transfusion). Hemoglobin testing can be repeated.
- •15. Impaired renal function or renal disease that constitutes a contraindication to contrast arteriography, including a screen/baseline creatinine of >2.0 mg/dL. Creatinine may be repeated following hydration for prerenal azotemia.
- •16. Active cancer except non-malignant tumors or basal cell carcinoma
- •17. Previous treatment with Plasmin
- •18. Treatment with full dose plasminogen activator (e.g., streptokinase (e.g., Streptase®, Kabikinase®), anistreplase (Eminase®), alteplase (e.g., Activase®), reteplase (e.g., Retavase®), tenecteplase (TNKase™), urokinase (UK, [Abbokinase®]) within the last 48 hours
- •19. Treatment with a glycoprotein IIb/IIIa class of platelet inhibitor within 5 days prior to study entry or at any time during the study, e.g., abciximab (ReoPro®), eptifibatide (Integrilin®) or tirofiban (Aggrastat®)
- •20. Treatment with oral an
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