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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

693 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-31

Study Completion Date

2021-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cardiac Surgery Cardiopulmonary Bypass High Risk Bleeding

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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The aprotinin group,

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.

standard of care

Intervention Type OTHER

retrospective study: standard of care

The tranexamic acid group

all patient receiving tranexamic acid following each local center standarded protocol

standard of care

Intervention Type OTHER

retrospective study: standard of care

Interventions

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standard of care

retrospective study: standard of care

Intervention Type OTHER

Eligibility Criteria

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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

* Patient not receiving antifibrinolytic therapy
* Patient with absolute contraindication to antifibrinolytics,
* Patient refusing to give access to their medical chart,
* Patient protected by the law, under guardianship or trusteeship,
* Patient deprived of liberty