CTRI/2011/04/001657招募中2 期
T05018-2004: A Phase 2, Randomized, Open-label (with BlindedPlasminogen 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 Grafi Occlusion
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 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
入排标准
入选标准
- •Inclusion Criteria
- •1. Unilateral limb ischemia: symptomatic, SVS acute ischemic Categories I and IIa
- •2. Onset of symptoms less than or equal to 14 days
- •3. Thrombosed (non-embolic) infrainguinal graft (synthetic, autologous, or single
- •outflow composite) or infrainguinal native artery. For native arteries, occlusions
- •of greater than or equal to 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 greater than or equal to 18 years
- •8. Women of child bearing potential must use adequate contraception for the duration
- •of the study and must have a negative pregnancy test prior to study entry
- •(Since there is no upper age limit defined for this trial for the CTRI registration purpose we have included the upper age limit to be considered as 99 years).
排除标准
- •Exclusion Criteria
- •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).
- •Contraindications To Thrombolysis
- •5. 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. Thesubject 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 Current Medical Status
- •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.
- •Prior/Concurrent Therapy
- •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.
- •19. Participation in another clinical study within 30 days prior to entry (imaging studies without investigative treatment are permitted), or concomita
研究者
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