Prospective Double Blinded Randomized Control Study of the Use of Fibrinogen in High-Risk Cardiac Surgery

• Status: Completed
• Trial end date: 2019-06-30
• Target enrollment: 0
• Participant gender: All

Summary

The aim of the study is to show that first line treatment with concentrated fibrinogen has superiority over the conventional therapy with fresh frozen plasma (FFP), platelets, and cryoprecipitate in perioperative management of bleeding after complex cardiac surgery.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nova Scotia Health Authority

Criteria

Inclusion Criteria:

All patients who are scheduled for elective complex cardiac surgical procedures including

• double procedures (aortic valve replacement (AVR)+CABG, mitral valve repair/replacement (MVR)+CABG, AVR+MVR)

• Redo-sternotomies

• Aortic root repair +/- AVR

Exclusion Criteria:

• Any known congenital or pre-existing bleeding disorder

• pre-existing clinically significant abnormal fibrinogen level (normal: 2.5-4.79g/l)

• severe liver disease (alanine aminotransferase or aspartate aminotransferase > 150 U/l)

• inability to provide informed consent

• emergency surgery

• pregnancy or nursing

• age under 18 years

• intake of anti-platelet drugs within2- 5 days preoperatively (low dose ASA is allowed)

• allergy to concentrated fibrinogen or other components in the product

• anemia (Hgb < 110)

• diagnosed deep vein thrombosis (DVT)

• pulmonary embolism

• acute stroke

• acute myocardial infarction