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

Completed
Conditions
High Risk Bleeding
Cardiopulmonary Bypass
Cardiac 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
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Proportion of patients with severe peri-operative bleedingday 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
NameTimeMethod
distribution of patients by UDPB classification categoryday 30 after surgery

proportion of patients with category 4 UDPB.

blood loss24 hours after chest closure

post operative chest tube blood loss

rescue surgery for bleedingday 30 after surgery

proportion of rescue surgery for bleeding

length of staythrough hospital discharge, an average of 30 days

hospital length of stay

mechanical ventilation48 hours after surgery

need to use mechanical ventilation for more than 48 hours

new renal replacement therapyup to day 30 after surgery

need for renal replacement therapy

mechanical ventilation timethrough intensive care unit discharge, an average of 30 days

duration of artificial ventilation (hours)

KDIGO score greater than or equal to 2day 7 after surgery

acute kidney injury defined by KDIGO score greater than or equal to 2

need for vasopressors/inotropesbeyond 24 hours after surgery

need for use postoperative vasopressors/inotropes for more than 24 hours

myocardial infarctionup to 30 day after surgery

occurrence of myocardial infarction

need for transfusionup to seven day after surgery

need for labil blood products and medicinal products derived from blood

short term mechanical circulatory supportup 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 eventup to 30 day after surgery

occurrence of embolic or thrombotic event

strokeup to 30 day after surgery

occurrence of stroke

vital status30 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

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