Randomized Ttrial to Establish the Efficacy of Hematinic Agents in Patietns With Mild Anemia Undergoing Total Hip or Knee Replacement in Avoiding Blood Transfusion
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
- 否
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
Mild anemia, normal iron studies, serum folate and vitamin B12 levels - will receive placebo
干预措施: Placebo (Drug)
Anemia, normal hematinics
Mild anemia, deficient iron, folate or vitamin B12 levels Iron supplement will be given
干预措施: Iron Supplement, (Drug)
Deficeicnt hematinics
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
Martin Ellis
Head Hematology Institute
Meir Medical Center
