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

University Hospital of Bordeaux

Status: Completed

Conditions: Cardiac Surgery; Cardiopulmonary Bypass; High Risk Bleeding

Treatments: Other: standard of care

Study type: Observational

Funder types: Other

Identifiers

NCT04804345

CHUBX 2020/67

Details and patient eligibility

About

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.

Full 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.

Enrollment: 693 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

693 participants in 2 patient groups

The aprotinin group,

Description:

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.

Treatment:

Other: standard of care

The tranexamic acid group

Description:

all patient receiving tranexamic acid following each local center standarded protocol

Treatment:

Other: standard of care