EUCTR2005-003637-41-GB进行中（未招募）1 期
A Phase II, Multi-Center, Single-Blinded, Placebo-Controlled Study to Evaluate the Safety and Feasibility of Hemoglobin-Based Oxygen Carrier-201 (HBOC-201, hemoglobin-glutamer-250 (bovine)]) on Wound Healing in Patients with Peripheral Vascular Disease and Who are Undergoing a Lower Limb Amputation due to Critical Lower Limb Ischemia (Phase II - Safety and Feasibility) - Effect of HBOC-201 on Wound Healing in Patients with Limb Amputation
Biopure Corporation0 个研究点开始时间: 2005年10月3日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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
- •-Subjects >18 years of age and <75 years of age
- •-Patients are scheduled for amputation at or above the ankle joint or a more proximal location but below or through the knee joint
- •-Patients have a documented severe lower extremity peripheral artery occlusive disease confirmed by:
- •-Clinical symptoms of critical limb ischemia and
- •-Frankly gangrenous tissue that merits amputation or
- •-Angiographic evidence of occlusive peripheral artery disease within one month of screening
- •-Patient or legal representative is willing to sign informed consent
- •-Patient is willing to follow the study instructions and follow-up visit
- •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
- •Patients with life expectancy less than 60 days.
- •-Any patient in whom the administration of 250 mL of colloidal solution daily for four consecutive days would be considered medically inappropriate.
- •-Patient has amputation above the knee joint or below the ankle joint.
- •-Patient has any amputation whereby primary skin closure is not technically feasible (e.g. Guillotine). These patients can later be randomized at the time of definitive amputation provided they meet the inclusion criteria.
- •-Patient has any amputation in which there is known infection at the site of skin closure, unless the infection is successfully treated prior to enrollment.
- •-Patient is a candidate for percutaneous or open surgery revascularization.
- •-Patient with peripheral vascular occlusion due to a cardioarterial emboli.
- •-Patient is a pregnant or breastfeeding woman.
- •-Previously demonstrated beef product allergy.
- •-Renal dysfunction requiring dialysis, or serum creatinine level >2.50 mg/dL(>220 micromol/L)
- •-Cardiac failure as defined by a NY class III/IV or left ventricular ejection fraction
- •-Myocardial infarction within the last 30 days
- •-Patients with cardiogenic shock (defined by a cardiac index < 2 L/min/m2 PCWP
- •> 18 mm Hg)
- •-Symptomatic cerebrovascular disease (e.g., stroke) diagnosed within last 6 months or known high grade carotid stenosis
- •-Uncontrolled diabetes as defined by a blood glucose = 400 mg/dL ( = 22 mmol/L)
- •-Patients with uncontrolled hypertension as defined by a blood pressure > 160 / 90 mm Hg despite the use of at least two antihypertensive medications or > 180 / 100 mm Hg if untreated
- •-Severe liver dysfunction as defined by total bilirubin = 3 mg/dL ( = 51 micromol/L) or an increase two times over the normal level of serum aspartate aminotransferase (AST) or serum alanine aminotransferase (ALT)
- •-Systemic mastocytosis
- •-Participation in another trial with an investigational drug or device including the follow-up period, within the last 30 days before enrollment
- •-Severe or unstable hepatic, gastrointestinal, cardiovascular, respiratory, neurological, psychiatric, hematological, renal or dermatological disease, or any other medical condition that might interfere with the evaluation of study medication
- •-Patient or legal representative is unable to provide informed consent
研究者
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