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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The aprotinin group, | 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. |
| |
| The tranexamic acid group | all patient receiving tranexamic acid following each local center standarded protocol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| standard of care | Other | retrospective study: standard of care |
|
| 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 |
| 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. |
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Inclusion Criteria:
patients undergoing cardiac on pump surgery at high risk for bleeding defined by :
Exclusion Criteria:
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consecutive patients undergoing cardiac surgery with a high risk of hemorrhage who have received a prophylactic infusion of either tranexamic acid or aprotinin and meeting the protocol criteria between july 2017 and october 2020 in seven university hospital centers.
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| Name | Affiliation | Role |
|---|---|---|
| Alexandre OUATTARA, MD, PhD | University Hospital, Bordeaux | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grenoble University Hospital | La Tronche | 38700 | France | |||
| Lyon University Hospital |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| 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 |
| Lyon |
| 69500 |
| France |
| Montpellier University Hospital | Montpellier | 34295 | France |
| Nantes University Hospital | Nantes | 44093 | France |
| North Val de Seine Paris University Hospital | Paris | 75877 | France |
| Georges Pompidou European University Hospital | Paris | 75908 | France |
| Bordeaux University Hospital | Pessac | 33604 | France |