AProtinin Versus Tranexamic Acid in Cardiac Surgery Patients With High-risk for Excessive Bleeding
- Conditions
- High Risk BleedingCardiopulmonary BypassCardiac Surgery
- Registration Number
- NCT04804345
- Lead Sponsor
- University Hospital, Bordeaux
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 693
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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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 hospital discharge, an average of 30 days hospital length of stay
mechanical ventilation 48 hours after surgery need to use mechanical ventilation for more than 48 hours
new renal replacement therapy up to day 30 after surgery need for renal replacement therapy
mechanical ventilation time through intensive care unit discharge, an average of 30 days duration of artificial ventilation (hours)
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
need for vasopressors/inotropes beyond 24 hours after surgery need for use postoperative vasopressors/inotropes for more than 24 hours
myocardial infarction up to 30 day after surgery occurrence of myocardial infarction
need for transfusion up to seven day after surgery need for labil blood products and medicinal products derived from blood
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)
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
vital status 30 days after surgery mortality after surgery
Trial Locations
- Locations (7)
Grenoble University Hospital
🇫🇷La Tronche, France
Lyon University Hospital
🇫🇷Lyon, France
Montpellier University Hospital
🇫🇷Montpellier, France
Nantes University Hospital
🇫🇷Nantes, France
North Val de Seine Paris University Hospital
🇫🇷Paris, France
Georges Pompidou European University Hospital
🇫🇷Paris, France
Bordeaux University Hospital
🇫🇷Pessac, France
Grenoble University Hospital🇫🇷La Tronche, France