APACHE: AProtinin Versus Tranexamic Acid in Cardiac Surgery Patients With High-risk for Excessive Bleeding
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Other: standard of care
retrospective study: standard of care
|
| The tranexamic acid group all patient receiving tranexamic acid following each local center standarded protocol |
Other: standard of care
retrospective study: standard of care
|
Outcome Measures
Primary Outcome Measures
- Proportion of patients with severe peri-operative bleeding [day 30 after surgery]
Proportion of patients with severe peri-operative bleeding defined by an UDPB (the Universal Definition of Perioperative Bleeding ) classification of 3 and 4.
Secondary Outcome Measures
- distribution of patients by UDPB classification category [day 30 after surgery]
proportion of patients with category 0 UDPB.
- distribution of patients by UDPB classification category [day 30 after surgery]
proportion of patients with category 1 UDPB.
- distribution of patients by UDPB classification category [day 30 after surgery]
proportion of patients with category 2 UDPB.
- distribution of patients by UDPB classification category [day 30 after surgery]
proportion of patients with category 3 UDPB.
- distribution of patients by UDPB classification category [day 30 after surgery]
proportion of patients with category 4 UDPB.
- blood loss [24 hours after chest closure]
post operative chest tube blood loss
- rescue surgery for bleeding [day 30 after surgery]
proportion of rescue surgery for bleeding
- length of stay [through intensive care unit discharge, an average of 30 days]
intensive care unit length of stay
- length of stay [through hospital discharge, an average of 30 days]
hospital length of stay
- KDIGO score greater than or equal to 2 [day 7 after surgery]
acute kidney injury defined by KDIGO score greater than or equal to 2
- mechanical ventilation time [through intensive care unit discharge, an average of 30 days]
duration of artificial ventilation (hours)
- mechanical ventilation [48 hours after surgery]
need to use mechanical ventilation for more than 48 hours
- need for transfusion [up to 48 hours after surgery]
need for labil blood products and medicinal products derived from blood
- need for transfusion [up to seven day after surgery]
need for labil blood products and medicinal products derived from blood
- need for vasopressors/inotropes [beyond 24 hours after surgery]
need for use postoperative vasopressors/inotropes for more than 24 hours
- vital status [30 days after surgery]
mortality after surgery
- new renal replacement therapy [up to day 30 after surgery]
need for renal replacement therapy
- short term mechanical circulatory support [up to 30 day after surgery]
need for short term mechanical circulatory support (extra corporeal life support, Impella TM pump, intra aortic balloon pump)
- myocardial infarction [up to 30 day after surgery]
occurrence of myocardial infarction
- embolic or thrombotic event [up to 30 day after surgery]
occurrence of embolic or thrombotic event
- stroke [up to 30 day after surgery]
occurrence of stroke
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Grenoble University Hospital | La Tronche | France | 38700 | |
| 2 | Lyon University Hospital | Lyon | France | 69500 | |
| 3 | Montpellier University Hospital | Montpellier | France | 34295 | |
| 4 | Nantes University Hospital | Nantes | France | 44093 | |
| 5 | North Val de Seine Paris University Hospital | Paris | France | 75877 | |
| 6 | Georges Pompidou European University Hospital | Paris | France | 75908 | |
| 7 | Bordeaux University Hospital | Pessac | France | 33604 |
Sponsors and Collaborators
- University Hospital, Bordeaux
Investigators
- Principal Investigator: Alexandre OUATTARA, MD, PhD, University Hospital, Bordeaux
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CHUBX 2020/67