Clinical trial NCT04804345: AProtinin Versus Tranexamic Acid in Cardiac Surgery Patients With High-risk for Excessive Bleeding
Official title: AProtinin Versus Tranexamic Acid in Cardiac Surgery Patients With High-risk for Excessive Bleeding
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Surgery
Cardiopulmonary Bypass
High Risk Bleeding
Keywords: cardiac surgery
cardiopulmonary bypass
massive peri-operative bleeding
antifibrinolytics
blood products transfusion
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2021-03-18
Enrollment: 693
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: consecutive patients undergoing cardiac surgery with a high risk of hemorrhage who have received a prophylactic infusion of either tranexamic acid or aprotinin and meeting the protocol criteria between july 2017 and october 2020 in seven university hospital centers.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients with severe peri-operative bleeding
timeFrame: day 30 after surgery
Secondary outcomes:
measure: distribution of patients by UDPB classification category
timeFrame: day 30 after surgery
measure: distribution of patients by UDPB classification category
timeFrame: day 30 after surgery
measure: distribution of patients by UDPB classification category
timeFrame: day 30 after surgery
measure: distribution of patients by UDPB classification category
timeFrame: day 30 after surgery
measure: distribution of patients by UDPB classification category
timeFrame: day 30 after surgery
measure: blood loss
timeFrame: 24 hours after chest closure
measure: rescue surgery for bleeding
timeFrame: day 30 after surgery
measure: length of stay
timeFrame: through intensive care unit discharge, an average of 30 days
measure: length of stay
timeFrame: through hospital discharge, an average of 30 days
measure: KDIGO score greater than or equal to 2
timeFrame: day 7 after surgery
measure: mechanical ventilation time
timeFrame: through intensive care unit discharge, an average of 30 days
measure: mechanical ventilation
timeFrame: 48 hours after surgery
measure: need for transfusion
timeFrame: up to 48 hours after surgery
measure: need for transfusion
timeFrame: up to seven day after surgery
measure: need for vasopressors/inotropes
timeFrame: beyond 24 hours after surgery
measure: vital status
timeFrame: 30 days after surgery
measure: new renal replacement therapy
timeFrame: up to day 30 after surgery
measure: short term mechanical circulatory support
timeFrame: up to 30 day after surgery
measure: myocardial infarction
timeFrame: up to 30 day after surgery
measure: embolic or thrombotic event
timeFrame: up to 30 day after surgery
measure: stroke
timeFrame: up to 30 day after surgery
Other outcomes:
Locations:
city: La Tronche
country: France
facility: Grenoble University Hospital
city: Lyon
country: France
facility: Lyon University Hospital
city: Montpellier
country: France
facility: Montpellier University Hospital
city: Nantes
country: France
facility: Nantes University Hospital
city: Paris
country: France
facility: North Val de Seine Paris University Hospital
city: Paris
country: France
facility: Georges Pompidou European University Hospital
city: Pessac
country: France
facility: Bordeaux University Hospital
Study officials:
affiliation: University Hospital, Bordeaux
name: Alexandre OUATTARA, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: