The Benefits of a Preoperative Anemia Management Program (PAMP)
2015年5月26日 更新者：Thomas R. Vetter, MD, MPH、University of Alabama at Birmingham
The goal of this study is to gain further insight into the comparative effectiveness of treating patients, who are found to be anemic before their elective surgery, with a series of weekly subcutaneous doses of a drug given before surgery, which stimulates the natural production of red blood cells (a so-called erythropoietic stimulating agent [ESA]) along with intravenous iron, in reducing the need for blood transfusions (donated by someone other than the patient) during and after adult total hip arthroplasty (hip replacement surgery).
The effects of a Preoperative Anemia Management Program (PAMP) on the patient's quality of recovery, health-related quality of life, fatigue, and rehabilitation pattern after surgery will also be examined.
A cost-effectiveness analysis will be performed to compare the cost of these commercially available, FDA-approved medications versus the cost of transfused blood
研究概览
详细说明
Patient blood management (PBM) involves the timely and conscientious use of the current best evidence in making medical and surgical decisions about the care of patients to maintain red blood cell levels, optimize blood clotting, and minimize blood loss, in an effort to improve patient outcome. PBM focuses on the treatment of the individual patient and comprises transfusion therapy and drug therapy. PBM is based on three points: (1) optimization of the (preoperative) red blood cell volume, (2) reduction of diagnostic, therapeutic, or intraoperative blood loss, and (3) increasing individual tolerance towards anemia and accurate blood transfusion triggers. PBM primarily identifies patients at risk for transfusion and provides a management plan aimed at reducing or eliminating anemia and the need for blood transfusion donated from someone other than the patient (allogeneic transfusion), thus reducing the risks, blood bank inventory pressures, and the escalating costs associated with transfusion. The implementation of a formal UAB Preoperative Anemia Management Program (PAMP) may help achieve consistent PBM.
Efforts will be made to coordinate patients' scheduled surgery date and their initial evaluation in the UAB Highlands Hospital Preoperative Assessment, Consultation, and Treatment (HPACT) Clinic, so that their first PACT Clinic visit occurs approximately 14 days prior to the planned total hip replacement or total knee replacement
研究类型
介入性
注册 (实际的)
51
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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Alabama
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Birmingham、Alabama、美国、35294
- UAB Highlands Hospital
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
19年 至 80年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 19 years to 80 years of age
- American Society of Anesthesiologists 1-3 status
- Undergoing total hip arthroplasty for osteoarthritis, (either a primary or replacement procedure, but not a revision procedure) OR avascular necrosis (AVN); OR undergoing total knee arthroplasty (replacement) for osteoarthritis
Exclusion Criteria:
- American Society of Anesthesiologists 4 status
- Severe anemia, defined as a hematocrit of < 30%
- History of hypercoagulability or thrombophilia (e.g, factor V Leiden)
- History of deep venous thrombosis (DVT) or venous thromboembolism (VTE) within last 12 months
- Current use of anticoagulants (e.g., heparin, warfarin, dabigatran, etc)
- Diagnosis of chronic renal insufficiency requiring dialysis
- Morbid obesity (BMI > 40)
- History of allergic reaction to intravenous iron
- History of allergic reaction to an erythropoietic stimulating agent (ESA)
- History of sickle cell disease
- History of hemochromatosis
- History of liver dysfunction or congestive heart failure
- History of substance abuse disorder
- History of major psychiatric disorder (e.g., major depression, bipolar disorder, axis II personality disorder, schizophrenia)
- Uncontrolled hypertension (defined as a systolic pressure ≥ 160 mmHg and/or a diastolic pressure ≥ 110 mmHg)
- History of uncontrolled cardiac arrhythmias, cerebrovascular accident (CVA), transient ischemic attack (TIA), acute coronary syndrome (ACS), or other arterial thrombosis. ACS includes unstable angina, Q wave myocardial infarction (QwMI), and non-Q wave myocardial infarction (NQMI) within 6 months
- History of pure red cell aplasia (PRCA) after treatment with an ESA
- History of seizure disorder
- Any active/current cancer within the last 12 months (not including non-melanoma skin cancer)
- Pregnancy or lactation
- Non-native English speaker (because validated Spanish language versions of two of the patient questionnaires are not available)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Anemia Treatment Group (AMG)
Group of patients who are diagnosed preoperatively as being anemic (defined as a Hgb < 13.0 g/dL and MCV < 100 fL, with a hematocrit between 30% and 39%, for males and females), who will receive an ESA (PROCRIT) and iron (Venofer) preoperatively.
|
AMG patients will receive a standardized and well-accepted intravenous dose of 200 mg of iron sucrose (Venofer®) at -14 days and -7 days before their planned surgery, and if indicated, based upon laboratory testing on the day of their surgery (if patient has a Hgb < 13.0 g/dL and hematocrit between 30% and 39%, for males and females).
An additional dose will be given on postoperative day 2.
其他名称：
AMG patients will receive a standardized and well-accepted subcutaneous dose of 40,000 IU of epoetin alfa (PROCRIT®) plus an intravenous dose of 200 mg of iron sucrose (Venofer®) at -14 days and -7 days before their planned surgery, and if indicated, based upon laboratory testing on the day of their surgery (if patient has a Hgb < 13.0 g/dL and hematocrit between 30% and 39%, for males and females).
其他名称：
An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices.
This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb < 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability.
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其他：Conventional Treatment Group (CTG)
Group of patients who are diagnosed preoperatively as being anemic (defined as a Hgb < 13.0 g/dL and MCV < 100 fL, with a hematocrit between 30% and 39%, for males and females), who will receive our current, conventional perioperative standard of care, which does not involve any preoperative anemia management (other than laboratory testing).
CTG patients will undergo routine perioperative laboratory testing/screening.
|
An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices.
This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb < 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability.
|
|
其他：Non Anemia Group (NAG)
Group of patients who are not anemic preoperatively, who will receive our current, conventional perioperative standard of care.
|
An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices.
This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb < 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of Subjects Requiring at Least One Blood Transfusion During Surgery.
大体时间：During surgery (less than 1 day)
|
The number of subjects who had blood transfusions (at least 1) during surgery
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During surgery (less than 1 day)
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Number of Subjects With Blood Transfusions After Surgery and Prior to Discharge From Hospital
大体时间：post surgery through discharge, an average of 2 days
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Number of subjects that had at least 1 blood transfusion from the end of surgery until discharge from hospital
|
post surgery through discharge, an average of 2 days
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Number of Subjects Requiring Blood Transfusions Post Hospital Discharge Through 90 Days After Surgery
大体时间：post hospital discharge through 90 days after surgery
|
number of subjects requiring blood transfusions after hospital discharge through 90 days after surgery
|
post hospital discharge through 90 days after surgery
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Health-related Quality of Life
大体时间：Baseline at 14 days before, on hospital discharge, and at two-weeks, 30 days, 60 days and 90 days after surgery
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Health-related quality of life measured with the SF-12V2; Western Ontario and McMaster University Osteoarthritis Index (WOMAC) Questionnaire; Oxford Hip Score or Oxford Knee Score; and Multidimensional Assessment of Fatigue (MAF) Scale
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Baseline at 14 days before, on hospital discharge, and at two-weeks, 30 days, 60 days and 90 days after surgery
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Thomas R Vetter, MD, MPH、University of Alabama at Birmingham
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2013年4月1日
初级完成 (实际的)
2015年1月1日
研究完成 (实际的)
2015年1月1日
研究注册日期
首次提交
2013年3月20日
首先提交符合 QC 标准的
2013年6月24日
首次发布 (估计)
2013年6月27日
研究记录更新
最后更新发布 (估计)
2015年5月28日
上次提交的符合 QC 标准的更新
2015年5月26日
最后验证
2015年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.