AProtinin Versus Tranexamic Acid in Cardiac Surgery Patients With High-risk for Excessive Bleeding

Study Overview
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Brief Summary
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In this before-after multicenter study the authors tested the hypothesis that the prophylactic use of aprotinin compared to tranexamic acid could reduce the proportion of patients presenting severe perioperative bleeding.

Detailed Description
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Perioperative bleeding remains a real challenge for physicians managing cardiac surgical patients. In patients at high risk for excessive bleeding the prophylactic use of antifibrinolytics may be useful. This study propose to compare the efficacity and innocuity of aprotinin and tranexamic acid to reduce the proportion of patient presenting severe peri-operative bleeding according the Universal Definition of Perioperative Bleeding (UDPB) classification.

Official Title
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AProtinin Versus Tranexamic Acid in Cardiac Surgery Patients With High-risk for Excessive Bleeding

Conditions
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Cardiac Surgery, Cardiopulmonary Bypass, High Risk Bleeding

Intervention / Treatment
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* Other: standard of care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients undergoing cardiac on pump surgery at high risk for bleeding defined by : Aorto-coronary bypasses surgery (2 or more) under dual platelet aggregation therapy (Primary or redo) Heart transplant (Primary or Redo) Infectious endocarditis (Primary or Redo) Ascending acute aortic dissection (Primary or Redo) Artificial heart / LVAD under CEC (Primary or Redo) Combined surgery, Redo Ascending aorta surgery, Redo Exclusion Criteria: Off pump cardiac surgery Patient not meeting the inclusion criteria Patient not receiving antifibrinolytic therapy Patient with absolute contraindication to antifibrinolytics, Patient refusing to give access to their medical chart, Patient not meeting the inclusion criteria Patient protected by the law, under guardianship or trusteeship, Patient deprived of liberty

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| The aprotinin group,<br>all patients receiving a first infusion 1M KIU before surgical incision followed by a steady dose of 250 000 KIU/h with an additional dose of 1M KIU added to the cardiopulmonary bypass unit. | Other: standard of care<br>* retrospective study: standard of care<br>|
| The tranexamic acid group<br>all patient receiving tranexamic acid following each local center standarded protocol | Other: standard of care<br>* retrospective study: standard of care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with severe peri-operative bleeding | Proportion of patients with severe peri-operative bleeding defined by an UDPB (the Universal Definition of Perioperative Bleeding ) classification of 3 and 4. | day 30 after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| distribution of patients by UDPB classification category | proportion of patients with category 0 UDPB. | day 30 after surgery | 
| distribution of patients by UDPB classification category | proportion of patients with category 1 UDPB. | day 30 after surgery | 
| distribution of patients by UDPB classification category | proportion of patients with category 2 UDPB. | day 30 after surgery | 
| distribution of patients by UDPB classification category | proportion of patients with category 3 UDPB. | day 30 after surgery | 
| distribution of patients by UDPB classification category | proportion of patients with category 4 UDPB. | day 30 after surgery | 
| blood loss | post operative chest tube blood loss | 24 hours after chest closure | 
| rescue surgery for bleeding | proportion of rescue surgery for bleeding | day 30 after surgery | 
| length of stay | intensive care unit length of stay | through intensive care unit discharge, an average of 30 days | 
| length of stay | hospital length of stay | through hospital discharge, an average of 30 days | 
| KDIGO score greater than or equal to 2 | acute kidney injury defined by KDIGO score greater than or equal to 2 | day 7 after surgery | 
| mechanical ventilation time | duration of artificial ventilation (hours) | through intensive care unit discharge, an average of 30 days | 
| mechanical ventilation | need to use mechanical ventilation for more than 48 hours | 48 hours after surgery | 
| need for transfusion | need for labil blood products and medicinal products derived from blood | up to 48 hours after surgery | 
| need for transfusion | need for labil blood products and medicinal products derived from blood | up to seven day after surgery | 
| need for vasopressors/inotropes | need for use postoperative vasopressors/inotropes for more than 24 hours | beyond 24 hours after surgery | 
| vital status | mortality after surgery | 30 days after surgery | 
| new renal replacement therapy | need for renal replacement therapy | up to day 30 after surgery | 
| short term mechanical circulatory support | need for short term mechanical circulatory support (extra corporeal life support, Impella TM pump, intra aortic balloon pump) | up to 30 day after surgery | 
| myocardial infarction | occurrence of myocardial infarction | up to 30 day after surgery | 
| embolic or thrombotic event | occurrence of embolic or thrombotic event | up to 30 day after surgery | 
| stroke | occurrence of stroke | up to 30 day after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiac surgery, cardiopulmonary bypass, massive peri-operative bleeding, antifibrinolytics, blood products transfusion