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

Cardiac Surgery Clinical Trial

— APACHE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04804345
• Other study ID #: CHUBX 2020/67
• Status: Completed
• Start date: March 31, 2021
• Est. completion date: August 31, 2021

Study information

• Verified date: March 2022
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 693
• Est. completion date: August 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Surgery
• Cardiopulmonary Bypass
• Hemorrhage
• High Risk Bleeding

Intervention

Other:
• standard of care
retrospective study: standard of care

Locations

Country	Name	City	State
France	Grenoble University Hospital	La Tronche
France	Lyon University Hospital	Lyon
France	Montpellier University Hospital	Montpellier
France	Nantes University Hospital	Nantes
France	Georges Pompidou European University Hospital	Paris
France	North Val de Seine Paris University Hospital	Paris
France	Bordeaux University Hospital	Pessac

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	day 30 after surgery
Secondary	distribution of patients by UDPB classification category	proportion of patients with category 0 UDPB.	day 30 after surgery
Secondary	distribution of patients by UDPB classification category	proportion of patients with category 1 UDPB.	day 30 after surgery
Secondary	distribution of patients by UDPB classification category	proportion of patients with category 2 UDPB.	day 30 after surgery
Secondary	distribution of patients by UDPB classification category	proportion of patients with category 3 UDPB.	day 30 after surgery
Secondary	distribution of patients by UDPB classification category	proportion of patients with category 4 UDPB.	day 30 after surgery
Secondary	blood loss	post operative chest tube blood loss	24 hours after chest closure
Secondary	rescue surgery for bleeding	proportion of rescue surgery for bleeding	day 30 after surgery
Secondary	length of stay	intensive care unit length of stay	through intensive care unit discharge, an average of 30 days
Secondary	length of stay	hospital length of stay	through hospital discharge, an average of 30 days
Secondary	KDIGO score greater than or equal to 2	acute kidney injury defined by KDIGO score greater than or equal to 2	day 7 after surgery
Secondary	mechanical ventilation time	duration of artificial ventilation (hours)	through intensive care unit discharge, an average of 30 days
Secondary	mechanical ventilation	need to use mechanical ventilation for more than 48 hours	48 hours after surgery
Secondary	need for transfusion	need for labil blood products and medicinal products derived from blood	up to 48 hours after surgery
Secondary	need for transfusion	need for labil blood products and medicinal products derived from blood	up to seven day after surgery
Secondary	need for vasopressors/inotropes	need for use postoperative vasopressors/inotropes for more than 24 hours	beyond 24 hours after surgery
Secondary	vital status	mortality after surgery	30 days after surgery
Secondary	new renal replacement therapy	need for renal replacement therapy	up to day 30 after surgery
Secondary	short term mechanical circulatory support	need for short term mechanical circulatory support (extra corporeal life support, Impella TM pump, intra aortic balloon pump)	up to 30 day after surgery
Secondary	myocardial infarction	occurrence of myocardial infarction	up to 30 day after surgery
Secondary	embolic or thrombotic event	occurrence of embolic or thrombotic event	up to 30 day after surgery
Secondary	stroke	occurrence of stroke	up to 30 day after surgery