Management of Bleeding Following Cardiopulmonary Bypass

Study Overview
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Brief Summary
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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.

Official Title
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Management of Excessive Bleeding Following Cardiopulmonary Bypass: A Pilot Feasibility Study

Conditions
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Hemorrhage, Cardiopulmonary Bypass

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | end of trial | 
| 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 |  | During and immediately following completion of bypass OR in the first 24 hours after admission to the IUC, if significant bleeding occurs | 
| 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 |  | First 24 hours after operation | 
| Assess the level of compliance to the Bleeding Management Algorithm |  | Immediate peri-operative period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | First 30 days post-operatively or until discharge, whichever comes first | 
| Recording serious adverse events, such as myocardial infarction, thrombo-embolic events, etc. |  | First 30 days post-operatively or discharge, whichever occurs first | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hemorrhage, cardiopulmonary bypass, blood component transfusion, hemostasis, surgical