Randomized Trial of Sucrosomial Iron Vs Intravenous Iron for Preoperative Anemia (RSIVI)
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Change in hemoglobin from baseline to day of surgery or procedure
研究概览
简要总结
50 patients with anemia scheduled for heart surgery or procedures will be randomized to receive either oral sucrosomial iron or standard-of-care intravenous iron before surgery to see if the oral iron is as effective as intravenous iron in increasing the red blood cell count.
详细描述
Participants will be randomly assigned in a 1 to 1 ratio to one of two treatment groups. One group will receive intravenous (IV) iron, and the other group will receive oral sucrosomial iron.
Participants assigned to the IV iron group will receive two infusions at the University of Rochester Medical Center Center for Perioperative Medicine. Intravenous iron will be administered through a small plastic tube placed into a vein. Saline may be used to maintain the IV line as needed.
Participants assigned to the oral sucrosomial iron group will receive capsules to take at home until the date of surgery, with a dosage of two capsules per day.
All other aspects of perioperative care will follow standard practice. A blood sample for complete blood count and iron studies will be obtained on the day of surgery. This is typically collected when the IV is placed, so an additional needle stick is usually not required.
Randomization applies only to the two treatment arms (intravenous iron and oral sucrosomial iron). The third arm is a non randomized observational cohort for data collection only.
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
- Double (Care Provider, Outcomes Assessor)
盲法说明
Observer blinded
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
- •Scheduled for elective cardiac surgical procedures, including:
- •Coronary artery bypass graft surgery (CABG)
- •Valve procedures
- •Aortic root procedures
- •Transcatheter aortic valve implantation (TAVI)
- •Hemoglobin <12 g/dL and ≥10 g/dL on a complete blood count obtained at the Center for Perioperative Medicine pre operative visit
- •Evidence of iron deficiency
- •Able to provide informed consent
- •Able to understand spoken and written English
排除标准
- •Scheduled for cardiac surgery requiring deep hypothermia or circulatory arrest
- •Undergoing heart transplantation or ventricular assist device placement
- •Lacking capacity to provide informed consent or unable to understand spoken and written English
- •Baseline hemoglobin >12 g/dL or <10 g/dL
- •Use of anticoagulant medications within 5 days of the Center for Perioperative Medicine visit, or planned initiation of anticoagulant therapy before surgery
- •History of hemoglobinopathy
- •History of hematologic malignancy
- •Bone marrow suppression from non nutritional causes
- •Vitamin B12 or folate deficiency
- •Known liver disease
- •Known kidney disease
- •Normal serum iron studies at baseline
研究组 & 干预措施
intravenous (IV) iron
If a participant is to receive IV iron, they will be scheduled to have two infusions, at the URMC Center for Perioperative Medicine (CPM). They will receive the iron through an IV, which is a small plastic tube inserted into a vein in the arm using a needle. This may require that saline water be inserted into the tube to keep the tube from clogging.
干预措施: Treatment with intravenous iron (Drug)
Sucrosomial Iron
If a participant is to receive oral iron capsules, they will be provided with enough capsules to last until the date of surgery and will take 2 capsules every day.
干预措施: Treatment with oral sucrosomial iron (Drug)
结局指标
主要结局
Change in hemoglobin from baseline to day of surgery or procedure
时间窗: From the pre operative visit to the day of surgery or procedure, up to approximately eight weeks
Change in hemoglobin in grams per deciliter from the baseline pre operative complete blood count to the complete blood count obtained on the day of surgery or procedure. Change will be calculated as hemoglobin on the day of surgery minus baseline hemoglobin.
次要结局
- Treatment compliance(From the pre operative visit to the day of surgery or procedure, up to approximately eight weeks)
- Proportion of participants receiving any blood transfusion(From the end of surgery or procedure through thirty days post procedure)
- Change in iron study values from baseline to the day of surgery or procedure(From the pre operative visit to the day of surgery or procedure, up to approximately eight weeks)
- Post operative complications(From the end of surgery or procedure through thirty days)
- Length of intensive care unit stay(30 days after hospital discharge)
- Length of hospital stay(30 days after hospital discharge)
研究者
Michael Eaton
Principal Investigator
University of Rochester