Fresh Autologous Whole Blood Transfusion After Cardiopulmonary Bypass
מילות מפתח
תַקצִיר
תיאור
Cardiac surgery carries a significant risk of bleeding requiring transfusion of stored blood products and blood transfusion associated with cardiac surgery consumes 20% of the blood supply worldwide. Although transfusion may be life-saving, significant risks of complications such as lung injury or even an increase in mortality are associated with transfusion. Decreasing transfusion requirements during cardiac surgery has the potential to reduce the rate of complications, improve patient outcomes, and reduce cost resulting in increased value for both the patient and the health system as a whole. Collection of autologous blood before cardiopulmonary bypass (CPB) for transfusion after CPB has been shown to be both safe and effective for reducing blood loss during cardiac surgery, but this intervention has not been targeted to a patient population at high risk for bleeding and transfusion. Fresh whole blood has the capacity to restore coagulation system function during profound coagulopathy in a trauma setting or following massive transfusion by an unknown mechanism. One unit of fresh whole blood is able to restore clotting function equivalent to that achieved by 10 units of pooled platelets. Autologous whole blood collection prior to CPB for transfusion post-operatively has been shown to improve coagulation and decrease clot lysis but is not routinely performed because 90% to 95% of patients do not have extensive blood loss and subsequent coagulopathy. Coupling accurate pre-operative bleeding risk prediction with autologous fresh whole blood collection for transfusion after CPB would target an established, low cost, low risk intervention to an at risk patient population who may experience significant benefit.
Red blood cell transfusion is performed to correct insufficient oxygen carrying capacity or oxygen delivery, but no robust measure of tissue oxygen delivery is currently available. Specific aim 2 will address this gap in knowledge by performing absolute quantification of citric acid cycle intermediates using mass spectrometry that are markers of mitochondrial respiration. Of particular interest, increased plasma levels of succinate have been shown to be associated with trauma associated mortality and the accumulation of succinate is likely due to reversal of flow of the succinate dehydrogenase complex in the absence of oxygen (unpublished data). Measurement of these markers before and after transfusion will determine the resuscitative capacity of allogenic packed red blood cells compared to fresh autologous whole blood.
תאריכים
| אומת לאחרונה: | 12/31/2019 |
| הוגש לראשונה: | 06/26/2017 |
| ההרשמה המשוערת הוגשה: | 06/28/2017 |
| פורסם לראשונה: | 07/01/2017 |
| העדכון האחרון הוגש: | 01/13/2020 |
| עדכון אחרון פורסם: | 01/17/2020 |
| תאריך תחילת לימוד בפועל: | 04/30/2020 |
| תאריך סיום משוער משוער: | 08/31/2020 |
| תאריך סיום משוער ללימודים: | 07/31/2021 |
מצב או מחלה
התערבות / טיפול
Other: Fresh Autologous whole blood transfusion
Other: Standard of Care Expectant Management of bleeding
שלב
קבוצות זרועות
| זְרוֹעַ | התערבות / טיפול |
|---|---|
| Experimental: Fresh Autologous whole blood transfusion The experimental group will have 15% of the estimated blood volume of autologous blood collected. This transfusion will be given at the end of the procedure. | Other: Fresh Autologous whole blood transfusion Subjects randomized this arm will receive fresh autologous whole blood |
| Active Comparator: Standard of Care Expectant Management of bleeding the control group that will receive the standard of care expectant management of bleeding and transfusion of allogenic banked blood products | Other: Standard of Care Expectant Management of bleeding the control group that will receive the standard of care expectant management of bleeding and transfusion of allogenic banked blood products |
קריטריונים לזכאות
| גילאים הזכאים ללימודים | 18 Years ל 18 Years |
| מינים הזכאים ללימודים | All |
| מקבל מתנדבים בריאים | כן |
| קריטריונים | Inclusion Criteria: 1. Adult subjects aged 18 to 90 2. Able to provide informed consent 3. Willing to accept autologous or allogenic blood transfusion 4. Scheduled for elective cardiac surgery with cardiopulmonary bypass Exclusion Criteria: 1. Pre-operative administration of allogenic blood bank products in the previous 3 months 2. Hemodynamically unstable defined as a systolic blood pressure less than 90 mmHg with a heart rate greater 100 or requiring intravenous vasopressor medications 3. Significant active infection or sepsis defined by positive blood culture or positive wound culture 4. Less than 50% predicted rate of requiring a blood transfusion during the perioperative time period 5. Hemoglobin less than 7 g/dl |
תוֹצָאָה
מדדי תוצאות ראשוניים
1. Estimated Blood Loss [Within 24 hours after surgery]
אמצעי תוצאה משניים
1. Number of allogenic transfusions given [31 days]
2. Severity of peri-operative stroke [31 days]
3. Incident of peri-operative stroke [31 days]
4. Development of Post-operative delirium [31 days]
5. Development of Myocardial Infarction [31 days]
6. Development of Heart failure [31 days]
7. Detection of New Onset Atrial fibrillation [31 days]
8. Development of Lung injury [31 days]
9. Time to extubation [31 days]
10. Development of Acute Kidney Injury [31 days]
11. Initiation of renal replacement therapy [31 days]
12. ICU length of stay [31 days]
13. Evaluation of Vasopressor requirements (1) [31 days]
14. Evaluation of Vasopressor requirements (2) [31 days]
