Kinetics of Plasma Fibrinogen in Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
The study intends to measure fibrinogen plasma levels during the first 24 hrs in cardiac and thoracic surgical patients who undergo surgical procedures using extracorporeal circulation.

Official Title
-----------------
Kinetics of Plasma Fibrinogen During Cardiac and Thoracic Aortic Surgery

Conditions
-----------------
Fibrinogens, Abnormal

Intervention / Treatment
-----------------
* Procedure: Fibrinogen plasma level


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective patients undergoing coronary artery bypass grafting, aortic valve replacement or thoracic aortic surgery Signed written informed consent Exclusion Criteria: Participation in another study Language barrier to understand study purposes (e.g. french as a native language) Preoperative low level of plasma fibrinogen (< 1.75 g/l) Preoperative anemia (Hb < 10g/dl) Emergency treatment Intake of anticoagulants other than aspirin within 14 days preceding surgery. Known coagulation disorder. Jehovah's witnesses

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Fibrinogen plasma level in CABG<br>In all patients undergoing coronary artery bypass grafting (CABG) the investigators plan to measure the fibrinogen plasma level | Procedure: Fibrinogen plasma level<br>* At 12 different time points investigators plan to measure the plasma fibrinogen level with conventional coagulation tests (Clauss fibrinogen) and with ROTEM.<br>|
| Fibrinogen plasma level in AVR<br>In all patients undergoing aortic valve replacement (AVR) the investigators plan to measure the fibrinogen plasma level | Procedure: Fibrinogen plasma level<br>* At 12 different time points investigators plan to measure the plasma fibrinogen level with conventional coagulation tests (Clauss fibrinogen) and with ROTEM.<br>|
| Fibrinogen plasma level in AAR<br>In all patients undergoing aortic arch replacement (AAR) the investigators plan to measure the fibrinogen plasma level | Procedure: Fibrinogen plasma level<br>* At 12 different time points investigators plan to measure the plasma fibrinogen level with conventional coagulation tests (Clauss fibrinogen) and with ROTEM.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma fibrinogen concentration | Conventional (Clauss) and thromboelastometric measurement (FIBTEM) | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Periprocedural thromboembolic complications |  | through study completion, an average of 1 year | 
| Thoracic drain loss | Measurement of the amount of blood collected by the thoracic drain (ml) | through study completion, an average of 1 year | 
| In-hospital mortality |  | through study completion, an average of 1 year | 
| Intensive Care Unit (ICU) length of stay |  | through study completion, an average of 1 year | 
| Platelet count | Measurement of platelet count in the laboratory | through study completion, an average of 1 year | 
| Prothrombin time (Quick) | Measurement of Quick in the laboratory | through study completion, an average of 1 year | 
| Activated partial thromboplastin time (aPTT) | Measurement of aPTT in the laboratory | through study completion, an average of 1 year | 
| Thromboelastometric (ROTEM) parameters (e.g., INTEM, EXTEM, HEPTEM) | Measurement of ROTEM parameter (unit mm) in the laboratory | through study completion, an average of 1 year | 
| Thrombin concentration | Thrombin concentration in the plasma as measured in the laboratory | through study completion, an average of 1 year |