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.

Study Timeline

• Study First Submitted: 2021-03-10
• Study First Submitted QC: 2021-03-15
• Study First Posted: 2021-03-18
• Study Start: 2021-03-31
• Primary Completion: 2021-08-31
• Study Completion: 2021-08-31
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-02
• Last Update Posted: 2022-03-03

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

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