Standard of care
Otherretrospective study: standard of care
NCT Number: NCT04804345
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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Notify Me18 year and older
All sexes
Observational
Grenoble University Hospital, La Tronche, France
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.
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 :
Exclusion criteria
retrospective study: standard of care
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.
Time frame: day 30 after surgery
proportion of patients with category 0 UDPB.
Time frame: day 30 after surgery
proportion of patients with category 1 UDPB.
Time frame: day 30 after surgery
proportion of patients with category 2 UDPB.
Time frame: day 30 after surgery
proportion of patients with category 3 UDPB.
Time frame: day 30 after surgery
proportion of patients with category 4 UDPB.
Time frame: 24 hours after chest closure
post operative chest tube blood loss
Time frame: day 30 after surgery
proportion of rescue surgery for bleeding
Time frame: through intensive care unit discharge, an average of 30 days
intensive care unit length of stay
Time frame: through hospital discharge, an average of 30 days
hospital length of stay
Time frame: day 7 after surgery
acute kidney injury defined by KDIGO score greater than or equal to 2
Time frame: through intensive care unit discharge, an average of 30 days
duration of artificial ventilation (hours)
Time frame: 48 hours after surgery
need to use mechanical ventilation for more than 48 hours
Time frame: up to 48 hours after surgery
need for labil blood products and medicinal products derived from blood
Time frame: up to seven day after surgery
need for labil blood products and medicinal products derived from blood
Time frame: beyond 24 hours after surgery
need for use postoperative vasopressors/inotropes for more than 24 hours
Time frame: 30 days after surgery
mortality after surgery
Time frame: up to day 30 after surgery
need for renal replacement therapy
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)
Time frame: up to 30 day after surgery
occurrence of myocardial infarction
Time frame: up to 30 day after surgery
occurrence of embolic or thrombotic event
Time frame: up to 30 day after surgery
occurrence of stroke
University Hospital, Bordeaux
Other
Acronym: APACHE
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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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