Fibrinogen and Bleeding After Cardiac Surgery

Study Overview
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Brief Summary
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The study hypothesis is that prophylactic fibrinogen infusion reduces postoperative bleeding and transfusion requirements after coronary artery bypass surgery (CABG) in patients with endogenous fibrinogen levels in the lower normal range. 60 patients will be included in a prospective, randomized double-blind placebo-controlled single center study.

Official Title
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Fibrinogen and Bleeding After Cardiac Surgery

Conditions
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Complications, Bleeding, Coronary Artery Disease

Intervention / Treatment
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* Drug: Fibrinogen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and Females Age 18 years and above Patients eligible for a first-time coronary artery bypass(CABG) surgery with a preoperative fibrinogen plasma concentration under 3,8 g/L Signed informed consent to participate in the study Exclusion Criteria: Patients undergoing redo surgery Clinical or laboratory signs of bleeding disorder Clinical or laboratory signs of significant liver disease, or,other significant disease or condition which in the investigators judgment interfere with hemostasis Any medications with agents which may interfere with hemostasis within 14 days prior to study start. Clopidogrel and warfarin are withdrawn at least 24 hours before surgery. Oral aspirin is allowed co-medication. Administration of other investigational drugs within eight weeks preceding the preentry examination Pregnant or lactating women

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>100 ml infusion of saline is given during 15 minutes after anesthesia induction before start of surgery. | Drug: Fibrinogen<br>* Fibrinogen 2 gr in 100 ml sterile water. The infusion is given during 15 minutes<br>* Other names: Haemocomplettan;|
| Experimental: Study drug<br>Fibrinogen 2g in 100 ml sterile water given during 15 minutes after anestesiainduction before surgery start | Drug: Fibrinogen<br>* Fibrinogen 2 gr in 100 ml sterile water. The infusion is given during 15 minutes<br>* Other names: Haemocomplettan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate safety of prophylactic fibrinogen infusion in patients with fibrinogen levels in the lower normal range undergoing cardiac surgery |  | 2 years | 
| Blood loss first 12 postoperative hours |  | 12h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transfusions |  | 7 days | 
| Biomarkers of coagulation, fibrinolysis and platelet function |  | 7 days | 
| Pharmcoeconomic analysis |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fibrinogen, Postoperative bleeding, Transfusions, CABG