Cardiac Complication During Procedure Clinical Trial
Official title:
The Use of Fibrinogen Concentrate in High-Risk Cardiac Surgery. A Prospective, Double-blinded, Randomized, Controlled Study
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.
All patients will be recruited from the Queen Elizabeth II (QEII) Health Sciences Center,
Halifax, Nova Scotia, which is the sole tertiary cardiac surgical referral center in Nova
Scotia that performs approximately 1000 open heart surgical procedures yearly, including more
than 700 isolated coronary artery bypass graft (CABG) procedures.
Inclusion criteria: All patients who are scheduled for elective complex cardiac surgical
procedures including, double procedures (aortic valve replacement+coronary artery bypass
graft , mitral valve replacement+coronary artery bypass graft , aortic valve
replacement+mitral valve replacement), redo-sternotomies, and aortic root repair +/-aortic
valve replacement.
Exclusion criteria: Any known congenital or preexisting bleeding disorder, preexisting
clinically significant abnormal fibrinogen level, severe liver disease (alanine
aminotransferase or aspartate aminotransferase > 150 U/l), inability of providing informed
consent, emergency surgery, pregnancy or nursing, age under 18 years, intake of anti-platelet
drugs within the last 2- 5 days before surgery (low dose aspirin is allowed) allergy to
concentrated fibrinogen or other components in the product, anemia (Hb < 110), diagnosed deep
venous thrombosis, pulmonary embolism, acute stroke or acute myocardial infarction.
The primary outcome: Cumulative perioperative amount (number of units and total volume) of
blood components used between the start of surgery and 24 hours after administration of the
study drug or placebo. 'Blood Components' are defined as all fresh components of blood (RBCs,
plasma, platelets, and Cryo).
The secondary outcomes: Fibrinogen levels, hematocrit, prothrombin time (PT), partial
prothrombin time (PTT), INR, platelet count, Hemoglobin (Hb), Thromboelastometry (ROTEM®,
clotting time (CT), clot formation time (CFT), Angle, maximum clot firmness (MCF),
Cardiovascular intensive care unit (CVICU-stay), Hospital-stay, In-Hospital Mortality,
Hemoglobin, adverse events (anaphylaxis, stroke, myocardial infarction, pulmonary embolism,
and deep vein thromboembolism) and usage of factor VII concentrate and human prothrombin
complex (factors II, VII,IX, X), total avoidance of transfusion after cardiopulmonary bypass
(CPB) 24h after administration of study drug or placebo.
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