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| ID | Type | Description | Link |
|---|---|---|---|
| 20100962-A1 |
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| Name | Class |
|---|---|
| University of Texas Southwestern Medical Center | OTHER |
| Johns Hopkins University | OTHER |
| Emory University | OTHER |
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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.
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| 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 |
| 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. |
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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:
Exclusion Criteria:
Ineligible patients include those:
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Study populations includes male and female patients over 18 kg in weight and less than 75 years old who are undergoing cardiopulmonary bypass and are theoretically at risk for significant bleeding in the peri-operative period
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| Name | Affiliation | Role |
|---|---|---|
| Marie E Steiner, MD, MS | University of Minnesota | Study Chair |
| Philip Greilich, MD | University of Texas Souwthwestern Medical Center | Principal Investigator |
| Nauder Faraday, MD | Johns Hopkins Medical Center | Principal Investigator |
| Nigel S Key, MB, FRCP | University of North Carolina, Chapel Hill | Principal Investigator |
| Jerrold Levy, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390-8894 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17258126 | Background | 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. | |
| 16131437 | Background | Levy JH, Tanaka KA, Steiner ME. Evaluation and management of bleeding during cardiac surgery. Curr Hematol Rep. 2005 Sep;4(5):368-72. |
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| First 30 days post-operatively or discharge, whichever occurs first |
| 14722166 | Background | 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. |