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临床试验/NCT01676740
NCT01676740Unknown不适用

Randomized Ttrial to Establish the Efficacy of Hematinic Agents in Patietns With Mild Anemia Undergoing Total Hip or Knee Replacement in Avoiding Blood Transfusion

Meir Medical Center1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2012年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
120
试验地点
1
主要终点
Perioperative blood transfusion

研究概览

简要总结

To establish the efficacy of screening for anemia and treatment of mild anemia with iron and vitamins prior to THR and TKR as a means of increasing hemoglobin and reducing perioperative allogeneic blood transfusion.

详细描述

Patients with mild anemia will be identified at preoperative clinic visit

  • Patients will be screened for inclusion and exclusion criteria
  • Eligible patients will have laboratory testing performed as follows: CBC, liver and kidney function tests, serum iron, transferrin, ferritin, serum folic acid, vitamin B12 and C-reactive protein
  • Patients will be assigned to a deficient group or non-deficient group depending upon laboratory hematinic values
  • Patients in the "non-deficient' group will be randomized using a computer-generated code to treatment or no treatment
  • Treatment will begin within 2 weeks of laboratory testing and 4-6 weeks prior to surgery.
  • Hematinic therapy will consist of oral ferric hydrochloride polymaltose 200 mg/d and folic acid 0.4 mg/d; sublingual vitamin B12 1000 µg three times a week
  • On the day of surgery laboratory testing will be performed as follows: CBC, kidney and liver function tests, serum iron, transferrin, ferritin, serum folic acid, vitamin B12 and C-reactive protein.
  • The same surgical team in each center will operate on all study patients and will be blinded to the preoperative hemoglobin
  • Routine postoperative management will be provided as determined by the treating physicians
  • Blood transfusion will be decided upon by a study physician at each center blinded to the patients' group assignment and preoperative hemoglobin
  • The primary outcome will be perioperative blood transfusion (from 24 hours prior to surgery until hospital discharge)
  • Secondary outcomes will be length of hospitalization, postoperative wound infection, walking ability across room at 30 days

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
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

入选标准

  • Age > 50 years
  • Ability to provide informed consent
  • Elective THR or TKR
  • Mild anemia: Hematocrit 29-39% in men, 29-36% in women

排除标准

  • Identified cause of anemia excluding hematinic deficiency
  • Known source of blood loss
  • Known coagulopathy
  • Unstable coronary syndrome in the previous 3 months
  • Pathologic fracture, presence of malignancy
  • Repeat THR or TKR
  • Orthopedic trauma within the previous 3 months
  • ASA class ≥ 4
  • Creatinine clearance < 30 ml/min
  • AST/ALT > 2x upper limit of normal
  • Preexisting use of hematinic agents
  • Planned acute normovolemic hemodilution
  • Refusal to receive blood products

研究组 & 干预措施

Mild anemia, normal hematinics

Placebo Comparator

Mild anemia, normal iron studies, serum folate and vitamin B12 levels - will receive placebo

干预措施: Placebo (Drug)

Anemia, normal hematinics

Experimental

Mild anemia, deficient iron, folate or vitamin B12 levels Iron supplement will be given

干预措施: Iron Supplement, (Drug)

Deficeicnt hematinics

Other

Iron supplement will be provided

干预措施: Iron Supplement, (Drug)

结局指标

主要结局

Perioperative blood transfusion

时间窗: 1 day prior to surgery until hospital discharge

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Martin Ellis

Head Hematology Institute

Meir Medical Center

研究点 (1)

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