NCT01345968终止4 期
Preoperative Intravenous Ferric Carboxymaltose (Ferinject) in Patients With Orthopedic Surgery and High Risk of Blood Loss
University Hospital Muenster2 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2011年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Number of RBC units
研究概览
简要总结
The primary purpose of this study is to evaluate the safety and efficacy of preoperative intravenous ferric carboxymaltose in patients with anemia undergoing hip or knee replacement
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age >= 18 years
- •Patients scheduled to undergo hip or knee replacement
- •8 g/dl < Hb < 13 g/dl for men and 8 g/dl < Hb < 12 g/dl for women at screening (3-4 weeks prior to surgery)
- •signed written informed consent
排除标准
- •immunosuppressive or myelosuppressive therapy
- •history of thromboembolic events
- •a concurrent medical condition(s) that would prevent compliance or participation or jeopardize the health of the patient
- •hypersensitivity to any component of the formulation
- •transfusion within 1 month prior to study inclusion
- •liver values 3 times higher than normal
- •active severe infection/inflammation
- •renal insufficiency
研究组 & 干预措施
NaCl 0.9%
Placebo Comparator
干预措施: NaCl 0.9% (Drug)
Ferinject
Experimental
干预措施: Ferinject 50 mg/ml (Drug)
结局指标
主要结局
Number of RBC units
时间窗: Until postoperative day 7
次要结局
- Frequency of postoperative complications(Until 6 weeks after surgical intervention)
- Length of hospital stay(6 weeks after surgical intervention)
- Blood transfusion rate(Until postoperative day 7)
研究者
研究点 (2)
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进行中（未招募）
不适用
Preoperative Intravenous Ferric Carboxymaltose (Ferinject) in Patients with Orthopaedic Surgery and High Risk of Blood Loss - PRIVIROPatients with iron deficiency anemia scheduled to undergo orthopedic surgery with high risk of bleedingMedDRA version: 14.1Level: PTClassification code 10058829Term: Elective surgerySystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 14.1Level: LLTClassification code 10044088Term: Total hip replacementSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 14.1Level: LLTClassification code 10005127Term: Bleeding postoperativeSystem Organ Class: 10022117 - Injury, poisoning and procedural complicationsMedDRA version: 14.1Level: LLTClassification code 10066573Term: Chronic iron deficiency anemiaSystem Organ Class: 10005329 - Blood and lymphatic system disordersMedDRA version: 14.1Level: LLTClassification code 10057129Term: Revision of total knee arthroplastySystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 14.1Level: LLTClassification code 10051536Term: Intraoperative bleedingSystem Organ Class: 10022117 - Injury, poisoning and procedural complicationsMedDRA version: 14.1Level: LLTClassification code 10022975Term: Iron deficiency anemia secondary to blood loss (chronic)System Organ Class: 10005329 - Blood and lymphatic system disordersMedDRA version: 14.1Level: PTClassification code 10069749Term: Internal fixation of spineSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 14.1Level: LLTClassification code 10051386Term: Wound bleedingSystem Organ Class: 10022117 - Injury, poisoning and procedural complicationsMedDRA version: 14.1Level: PTClassification code 10020096Term: Hip arthroplastySystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 14.1Level: LLTClassification code 10022976Term: Iron deficiency anemia secondary to inadequate dietary iron intakeSystem Organ Class: 10005329 - Blood and lymphatic system disordersMedDRA versionEUCTR2010-024115-14-DEniversity Hospital Muenster
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