An observational study in Cardiac Surgery, Cardiopulmonary Bypass and High Risk Bleeding, sponsored by University Hospital, Bordeaux. Completed at 7 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-03.
Sponsored by University Hospital, Bordeaux · Observational
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.
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.
University Hospital, Bordeaux is the lead sponsor of 803 studies on the registry; 194 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
patients undergoing cardiac on pump surgery at high risk for bleeding defined by :
Exclusion Criteria:
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.
Other: standard of care
all patient receiving tranexamic acid following each local center standarded protocol
Other: standard of care
retrospective study: standard of care
Proportion of patients with severe peri-operative bleeding
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
distribution of patients by UDPB classification category
proportion of patients with category 0 UDPB.
Time frame: day 30 after surgery
distribution of patients by UDPB classification category
proportion of patients with category 1 UDPB.
Time frame: day 30 after surgery
distribution of patients by UDPB classification category
proportion of patients with category 2 UDPB.
Time frame: day 30 after surgery
distribution of patients by UDPB classification category
proportion of patients with category 3 UDPB.
Time frame: day 30 after surgery
distribution of patients by UDPB classification category
proportion of patients with category 4 UDPB.
Time frame: day 30 after surgery
blood loss
post operative chest tube blood loss
Time frame: 24 hours after chest closure
rescue surgery for bleeding
proportion of rescue surgery for bleeding
Time frame: day 30 after surgery
length of stay
intensive care unit length of stay
Time frame: through intensive care unit discharge, an average of 30 days
length of stay
hospital length of stay
Time frame: through hospital discharge, an average of 30 days
KDIGO score greater than or equal to 2
acute kidney injury defined by KDIGO score greater than or equal to 2
Time frame: day 7 after surgery
mechanical ventilation time
duration of artificial ventilation (hours)
Time frame: through intensive care unit discharge, an average of 30 days
mechanical ventilation
need to use mechanical ventilation for more than 48 hours
Time frame: 48 hours after surgery
need for transfusion
need for labil blood products and medicinal products derived from blood
Time frame: up to 48 hours after surgery
need for transfusion
need for labil blood products and medicinal products derived from blood
Time frame: up to seven day after surgery
need for vasopressors/inotropes
need for use postoperative vasopressors/inotropes for more than 24 hours
Time frame: beyond 24 hours after surgery
vital status
mortality after surgery
Time frame: 30 days after surgery
new renal replacement therapy
need for renal replacement therapy
Time frame: up to day 30 after surgery
short term mechanical circulatory support
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
myocardial infarction
occurrence of myocardial infarction
Time frame: up to 30 day after surgery
embolic or thrombotic event
occurrence of embolic or thrombotic event
Time frame: up to 30 day after surgery
stroke
occurrence of stroke
Time frame: up to 30 day after surgery
Plan to share: No
No publications or documents are linked to this record.
Ran from Mar 2021 to primary completion in Aug 2021, 5 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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