Fibrinogens, Abnormal
Conditions
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.
Interventions
PROCEDUREFibrinogen plasma level
At 12 different time points investigators plan to measure the plasma fibrinogen level with conventional coagulation tests (Clauss fibrinogen) and with ROTEM.
Sponsors
Insel Gruppe AG, University Hospital Bern
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma fibrinogen concentration | through study completion, an average of 1 year | Conventional (Clauss) and thromboelastometric measurement (FIBTEM) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Thoracic drain loss | through study completion, an average of 1 year | Measurement of the amount of blood collected by the thoracic drain (ml) |
| 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 | through study completion, an average of 1 year | Measurement of platelet count in the laboratory |
| Periprocedural thromboembolic complications | through study completion, an average of 1 year | — |
| Activated partial thromboplastin time (aPTT) | through study completion, an average of 1 year | Measurement of aPTT in the laboratory |
| Thromboelastometric (ROTEM) parameters (e.g., INTEM, EXTEM, HEPTEM) | through study completion, an average of 1 year | Measurement of ROTEM parameter (unit mm) in the laboratory |
| Thrombin concentration | through study completion, an average of 1 year | Thrombin concentration in the plasma as measured in the laboratory |
| Prothrombin time (Quick) | through study completion, an average of 1 year | Measurement of Quick in the laboratory |
Countries
Switzerland
Outcome results
None listed