Management of Bleeding Following Cardiopulmonary Bypass
Management of Excessive Bleeding Following Cardiopulmonary Bypass: A Pilot Feasibility Study
We believe ongoing bleeding during complex cardiac surgery can be accurately measured and that administration of a specific blood product replacement strategy designed to optimally slow or stop the bleeding can be followed by the during the operation.
Patients at risk of significant bleeding after complex cardiac surgery will be approached to allow their operation to be watched by study personnel to see if ongoing blood loss can be accurately measured and to see how quickly a prescribed, standardized blood product replacement protocol to control the bleeding does slow or stop the bleeding. Permission to review the medical record to see if bleeding risk features can be identified and permission to follow the patient after surgery to see how they recover is also requested.
研究概览
研究类型
注册 (实际的)
联系人和位置
学习地点
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Texas
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Dallas、Texas、美国、75390-8894
- University of Texas Southwestern Medical Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
Eligible male and female patients will include those who are over 18 kg (identified as the lower inclusion threshold so as to standardize CPB circuit dilution) and less than 75 years old (to limit excessive stroke risk) and at theoretically increased risk for excessive bleeding following cardiopulmonary bypass, including patients:
- undergoing repeat sternotomy, or
- undergoing combined procedures (i.e. - valve and coronary artery surgery), or
- undergoing multiple valve surgery, or
- undergoing aortic root replacement with/without deep hypothermic circulatory arrest, or
- undergoing complex congenital cardiac surgery
Exclusion Criteria:
Ineligible patients include those:
- with known coagulation factor deficiency, or
- refusing to receive donor blood products if necessary, or
- undergoing emergency surgery, or
- undergoing their first coronary artery bypass surgery or their first valve repair/replacement, or
- with history of previous stroke or other significant thromboembolic event within 6 months (such as pulmonary embolism, valve obstruction [if not replacing this valve in upcoming operation], renal vein thrombosis, acute MI, DVT ), or
- with known thrombophilia, or
- with active infection (bacteremia, sepsis, endocarditis, meningitis, urinary tract infection, cholecystitis, cellulitis, pneumonia)
- pregnant, or
- weight > 150 kg or < 18 kg
学习计划
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
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Tabulate the number of high risk subjects that must be screened and consented in order to find twenty subjects that meet the criteria of excessive bleeding following conventional therapy
大体时间：end of trial
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end of trial
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Determine blood loss, bleeding rate and blood transfusion prior to and following completion of algorithm-guided conventional transfusion therapy,including measured loss, rate of loss, volume of transfusion
大体时间：During and immediately following completion of bypass OR in the first 24 hours after admission to the IUC, if significant bleeding occurs
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During and immediately following completion of bypass OR in the first 24 hours after admission to the IUC, if significant bleeding occurs
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Assess the relative accuracy and clinical relevance of measuring bleeding rate, blood loss and blood transfusion in the first 24 hours following designation of "excessive bleeding", including measured hourly outputs, rate of output and volume transfused
大体时间：First 24 hours after operation
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First 24 hours after operation
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Assess the level of compliance to the Bleeding Management Algorithm
大体时间：Immediate peri-operative period
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Immediate peri-operative period
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次要结果测量
结果测量 |
大体时间 |
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Tabulating adverse outcomes, including: 1) rate of re-exploration within the next 24 hours, 2) use of rescue therapeutics in accordance with local practice, and 3) mortality within 30 days
大体时间：First 30 days post-operatively or until discharge, whichever comes first
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First 30 days post-operatively or until discharge, whichever comes first
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Recording serious adverse events, such as myocardial infarction, thrombo-embolic events, etc.
大体时间：First 30 days post-operatively or discharge, whichever occurs first
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First 30 days post-operatively or discharge, whichever occurs first
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合作者和调查者
调查人员
- 学习椅：Marie E Steiner, MD, MS、University of Minnesota
- 首席研究员：Philip Greilich, MD、University of Texas Souwthwestern Medical Center
- 首席研究员：Nauder Faraday, MD、Johns Hopkins Medical Center
- 首席研究员：Nigel S Key, MB, FRCP、University of North Carolina, Chapel Hill
- 首席研究员：Jerrold Levy, MD、Emory University
出版物和有用的链接
一般刊物
- Steiner ME, Despotis GJ. Transfusion algorithms and how they apply to blood conservation: the high-risk cardiac surgical patient. Hematol Oncol Clin North Am. 2007 Feb;21(1):177-84. doi: 10.1016/j.hoc.2006.11.009.
- Levy JH, Tanaka KA, Steiner ME. Evaluation and management of bleeding during cardiac surgery. Curr Hematol Rep. 2005 Sep;4(5):368-72.
- Avidan MS, Alcock EL, Da Fonseca J, Ponte J, Desai JB, Despotis GJ, Hunt BJ. Comparison of structured use of routine laboratory tests or near-patient assessment with clinical judgement in the management of bleeding after cardiac surgery. Br J Anaesth. 2004 Feb;92(2):178-86. doi: 10.1093/bja/aeh037.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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出血的临床试验
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Wake Forest University Health Sciences主动，不招人