NCT01805180已完成不适用
A Controlled Evaluation of the Spectra Optia® Apheresis System's Granulocyte / Polymorphonuclear (PMN) Cell Collection Procedure
Terumo BCT6 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2013年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 6
- 主要终点
- Granulocyte/PMN Cell Collection Efficiency
研究概览
简要总结
The purpose of this study is to compare the procedures for the collection PMN cells on Terumo BCT's Spectra Optia® and COBE® Spectra Apheresis Systems.
详细描述
The purpose of this study is to compare the procedures for the collection of granulocyte/ polymorphonuclear (PMN) cells on Terumo BCT's Spectra Optia® and COBE® Spectra Apheresis Systems and to establish the non-inferiority of the Spectra Optia Apheresis System with respect to the primary study endpoint, granulocyte/PMN cell collection efficiency.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Acceptable health status and vital signs per the AABB blood donation guidelines to permit blood donation, including:
- •Blood pressure ≥ 90/50 and ≤ 200/120 mmHg,
- •Pulse > 40 and < 100 beats/min, and
- •Temperature < 99.5ºFahrenheit (F).
- •Able to read, understand, and sign an English informed consent form.
- •Age ≥ 18 years.
- •Weight ≥ 50kg and < 227kg.
- •Male or non-pregnant, non-nursing female (a negative serum pregnancy test at screening and a negative urine pregnancy test prior to each mobilization).
- •Acceptable screening laboratory test results prior to the first PMN cell mobilization, including:
- •WBC count in the range: 3,500-10,800/uL,
- •Hematocrit in the range: 38-65%,
- •Platelet count in the range: 150,000-400,000/uL,
- •Coagulation tests: PT not greater than 1.1 times the upper limit of the local laboratory reference range; PTT not greater than 1.2 times the upper limit of the local laboratory reference range,
- •Serum electrolyte concentrations: potassium in the range 3.6-5.1 mmol/L; calcium in the range 8.5-10.3 mg/dL,
- •Serum creatinine not greater than 1.5mg/dL, and
- •ALT not greater than 1.5 times the upper limit of the local laboratory reference range. *** Up to two (2) of the above screening laboratory test results may fall outside of these ranges, if in the judgment of the principal investigator or designee, they do not constitute a significant risk to the subject. Any excused deviations from the above will be listed and summarized with the final report.***
- •Adequate dual peripheral venous access to allow collection of granulocytes (PMN cells) and return of remaining cells, platelets and plasma.
- •If male, willing to use a condom during sexual relations with a female partner of child bearing potential until 48 hours following each G-CSF injection.
- •If female, willing to use a medically-acceptable contraceptive until 48 hours following each G-CSF injection.
排除标准
- •Positive screening for any of the following: HIV, HBV (except isolated HB core Ab reactivity), HCV, HTLV, Syphilis or West Nile Virus.
- •Currently pregnant or breast-feeding.
- •Collection or loss of specific volumes of whole blood or blood components during specified timeframes:
- •more than 550mL of whole blood within the prior 56 days, or
- •more than 3L of whole blood or 1.5L of red blood cells within the prior 12 months, or
- •more than 12L of plasma within the prior 12 months, or
- •a leukapheresis within the prior six weeks, or
- •a plateletpheresis within the prior 48 hours or two within the prior 7 days or twenty-four within the last 12 months, or
- •a plasmapheresis within the prior 48 hours or two within the prior 7 days.
- •History of congestive heart failure.
- •History of uncontrolled hypertension (SBP/DBP >200/120 mmHg).
- •History or suspicion of active, peptic ulcer disease.
- •History of diabetes mellitus.
- •History of hematologic malignancy or chronic hematologic disorder.
- •Family history (parents, siblings, children) of hematologic malignancy.
- •History of deep vein thrombosis or venous thromboembolism, or bleeding disorder.
- •History of sickle cell disease or a positive SickleDex screen.
- •History of iritis or episcleritis.
- •History of autoimmune condition or disorder, unless approved by principal investigator.
- •Presence of psychological traits, or physiological or medical conditions that, in the opinion of the investigator, would make the subject unlikely to tolerate the procedures or complete the study.
- •History of use/anticipated need for lithium.
- •Received a G-CSF injection in the prior 4 months.
- •Known hypersensitivity to ethylene oxide.
- •Known hypersensitivity to G-CSF or hypersensitivity to any E. coli-derived products.
- •Known hypersensitivity to HES or corn.
- •Concurrent participation in another clinical trial or participation in a clinical trial within the past 30 days.
- •Subject is being treated with calcium channel blockers and/or antiepileptic medications. Note: This applies only to Subjects at Bonfils Blood Center whose collected product will undergo neutrophil function testing.
结局指标
主要结局
Granulocyte/PMN Cell Collection Efficiency
时间窗: within 1 hour prior and within 5 minutes after each collection procedure
The primary endpoint is the granulocyte/PMN cell collection efficiency (CE) associated with the Granulocyte (PMN) Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems. CE is a measurement of device performance calculated using donor and blood product blood counts collected immediately before and after the PMN collection procedure.
次要结局
- Characterization of Blood Product - PMN Cell Yield(within 5 minutes after each collection procedure)
- Characterization of Blood Product - PMN Cell Yield Per Liter of Blood Processed(within 5 minutes after each collection procedure)
- Characterization of the Blood Product - PMN Cell Viability(within 5 minutes after collection procedure)
- Characterization of the Blood Product - Volume(within 5 minutes after collection procedure)
- Usability/Assessment of System Operation - Device Malfunctions(Result know immediately upon successful completion of procedure)
- Performance(within 1 hour prior and within 5 minutes after each collection procedure)
- Characterization of the Blood Product - RBC Contamination(within 5 minutes after collection procedure)
- Safety(48-hours after last procedure)
- Usability/Assessment of System Operation - Time(Result captured immediately upon completion of procedure)
- Usability/Assessment of System Operation - Adjustments(Adjustments known immediately upon completion of the procedure)
研究者
研究点 (6)
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