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Completed

NCT Number: NCT04804345

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Grenoble University Hospital, La Tronche, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard of care

Other

retrospective study: standard of care

Primary outcomes

  1. Proportion of patients with severe peri-operative bleeding

    Time frame: 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 outcomes

  1. distribution of patients by UDPB classification category

    Time frame: day 30 after surgery

    proportion of patients with category 0 UDPB.

  2. distribution of patients by UDPB classification category

    Time frame: day 30 after surgery

    proportion of patients with category 1 UDPB.

  3. distribution of patients by UDPB classification category

    Time frame: day 30 after surgery

    proportion of patients with category 2 UDPB.

  4. distribution of patients by UDPB classification category

    Time frame: day 30 after surgery

    proportion of patients with category 3 UDPB.

  5. distribution of patients by UDPB classification category

    Time frame: day 30 after surgery

    proportion of patients with category 4 UDPB.

  6. blood loss

    Time frame: 24 hours after chest closure

    post operative chest tube blood loss

  7. rescue surgery for bleeding

    Time frame: day 30 after surgery

    proportion of rescue surgery for bleeding

  8. length of stay

    Time frame: through intensive care unit discharge, an average of 30 days

    intensive care unit length of stay

  9. length of stay

    Time frame: through hospital discharge, an average of 30 days

    hospital length of stay

  10. KDIGO score greater than or equal to 2

    Time frame: day 7 after surgery

    acute kidney injury defined by KDIGO score greater than or equal to 2

  11. mechanical ventilation time

    Time frame: through intensive care unit discharge, an average of 30 days

    duration of artificial ventilation (hours)

  12. mechanical ventilation

    Time frame: 48 hours after surgery

    need to use mechanical ventilation for more than 48 hours

  13. need for transfusion

    Time frame: up to 48 hours after surgery

    need for labil blood products and medicinal products derived from blood

  14. need for transfusion

    Time frame: up to seven day after surgery

    need for labil blood products and medicinal products derived from blood

  15. need for vasopressors/inotropes

    Time frame: beyond 24 hours after surgery

    need for use postoperative vasopressors/inotropes for more than 24 hours

  16. vital status

    Time frame: 30 days after surgery

    mortality after surgery

  17. new renal replacement therapy

    Time frame: up to day 30 after surgery

    need for renal replacement therapy

  18. short term mechanical circulatory support

    Time frame: up to 30 day after surgery

    need for short term mechanical circulatory support (extra corporeal life support, Impella TM pump, intra aortic balloon pump)

  19. myocardial infarction

    Time frame: up to 30 day after surgery

    occurrence of myocardial infarction

  20. embolic or thrombotic event

    Time frame: up to 30 day after surgery

    occurrence of embolic or thrombotic event

  21. stroke

    Time frame: up to 30 day after surgery

    occurrence of stroke

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Acronym: APACHE

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 18, 2021
Registry last updated
Mar 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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