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

NCT04804345 | Completed

• 1 other identifier: CHUBX 2020/67
• Study Type: observational
• Target: 693
• Locations: 1 country
• Sites: 7

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.

Conditions

Cardiac Surgery; Cardiopulmonary Bypass; High Risk Bleeding

Keywords

cardiac surgery; cardiopulmonary bypass; massive peri-operative bleeding; antifibrinolytics; blood products transfusion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (21)

• distribution of patients by UDPB classification category

  day 30 after surgery

• distribution of patients by UDPB classification category

  day 30 after surgery

• distribution of patients by UDPB classification category

  day 30 after surgery

• distribution of patients by UDPB classification category

  day 30 after surgery

• distribution of patients by UDPB classification category

  day 30 after surgery

Study Arms (2)

The aprotinin group,

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

The tranexamic acid group

all patient receiving tranexamic acid following each local center standarded protocol

Other: standard of care

Interventions

standard of care OTHER

retrospective study: standard of care

The aprotinin group,; The tranexamic acid group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• Off pump cardiac surgery
• Patient not receiving antifibrinolytic therapy
• Patient with absolute contraindication to antifibrinolytics,
• Patient refusing to give access to their medical chart,
• Patient protected by the law, under guardianship or trusteeship,
• Patient deprived of liberty

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (7)

Grenoble University Hospital

La Tronche, 38700, France

Location

Lyon University Hospital

Lyon, 69500, France

Location

Montpellier University Hospital

Montpellier, 34295, France

Location

Nantes University Hospital

Nantes, 44093, France

Location

North Val de Seine Paris University Hospital

Paris, 75877, France

Location

Georges Pompidou European University Hospital

Paris, 75908, France

Location

Bordeaux University Hospital

Pessac, 33604, France

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Alexandre OUATTARA, MD, PhD

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2021
• First Posted: March 18, 2021
• Study Start: March 31, 2021
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2021
• Last Updated: March 3, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (7)