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

University Hospital, Bordeaux693 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

693

Conditions

Cardiac Surgery Cardiopulmonary Bypass High Risk Bleeding

Interventions

standard of careOTHER

retrospective study: standard of care

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (7)

Grenoble University Hospital

La Tronche, France

Lyon University Hospital

Lyon, France

Montpellier University Hospital

Montpellier, France

Nantes University Hospital

Nantes, France

Outcomes

Primary Outcomes

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.