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.
調査の概要
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Texas
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Dallas、Texas、アメリカ、75390-8894
- University of Texas Southwestern Medical Center
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
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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
時間枠：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
時間枠：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
時間枠：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
時間枠：Immediate peri-operative period
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Immediate peri-operative period
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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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
時間枠：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.
時間枠：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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協力者と研究者
スポンサー
捜査官
- スタディチェア：Marie E Steiner, MD, MS、University of Minnesota
- 主任研究者：Philip Greilich, MD、University of Texas Souwthwestern Medical Center
- 主任研究者：Nauder Faraday, MD、Johns Hopkins Medical Center
- 主任研究者：Nigel S Key, MB, FRCP、University of North Carolina, Chapel Hill
- 主任研究者：Jerrold Levy, MD、Emory University
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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