EUCTR2010-019760-36-CZ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
Grifols Therapeutics, Incorporated0 个研究点目标入组 160 人开始时间: 2010年8月16日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 160
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 (Note: Only the sites that have the capability of correcting the underlying lesion in the native artery [eg, appropriate supply of the
- •required stents or long angioplasty balloons] will enroll subjects with occluded native artery.)
- •4. Diagnosis of occlusive thrombus in the graft or artery by arteriography after informed consent is obtained
- •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 35
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 35
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™),
- •XML File Identifier: 5lUQYyZboSugeIeEkSwfhzFzVcs=
- •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
研究者
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