EUCTR2010-019760-36-SK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 100 人开始时间: 2010年7月19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
- 100
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 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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
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. Cardiopulmonary resuscitation in the last year
- •4. Previous systemic or anaphylactoid allergy to contrast agent, streptokinase, or blood products (subjects allergic to shellfish or iodine are permitted to enter the study).
- •5. Ineligible for thrombolytic treatment for any reason
- •6. Active graft infection
- •7. Occlusion occurred within one month of synthetic graft placement
- •8. Occlusion occurred within 6 months of autologous graft placement
- •9. A sequential composite graft with dual outflows to correct multiple occlusions
- •10. Deemed by the Investigator to be medically unable to tolerate open vascular procedure
- •11. Known prothrombotic state, e.g., anti-cardiolipin antibody, human immunodeficiency virus (HIV)-associated peripheral vascular disease
- •12. Known contraindication to heparin (e.g., history of heparin-induced thrombocytopenia)
- •13. 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.
- •14. 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.
- •15. Previous treatment with Plasmin
- •16. 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
- •17. 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®)
- •18. Treatment with oral anticoagulants (e.g., warfarin, acenocumarol), and with an international normalized ratio (INR) of >1.7 (elevated INR at screening may be corrected prior to study enrollment). INR testing can be repeated.
研究者
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