Viewing Study NCT04804345



Ignite Creation Date: 2024-05-06 @ 3:55 PM
Last Modification Date: 2024-10-26 @ 1:59 PM
Study NCT ID: NCT04804345
Status: COMPLETED
Last Update Posted: 2022-03-03
First Post: 2021-03-10

Brief Title: AProtinin Versus Tranexamic Acid in Cardiac Surgery Patients With High-risk for Excessive Bleeding
Sponsor: University Hospital Bordeaux
Organization: University Hospital Bordeaux

Study Overview

Official Title: AProtinin Versus Tranexamic Acid in Cardiac Surgery Patients With High-risk for Excessive Bleeding
Status: COMPLETED
Status Verified Date: 2022-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: APACHE
Brief 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
Detailed 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None