Kinetics of Plasma Fibrinogen in Cardiac Surgery

Kinetics of Plasma Fibrinogen During Cardiac and Thoracic Aortic Surgery

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.

Study Overview

• Status: Completed
• Conditions: Fibrinogens, Abnormal
• Intervention / Treatment: Procedure: Fibrinogen plasma level

• Study Type: Observational
• Enrollment (Actual): 26

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • University Hospital Bern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing cardiac surgery with extracorporeal bypass

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

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

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

Collaborators and Investigators

• Sponsor: University Hospital Inselspital, Berne
• Investigators: Principal Investigator: Gabor Erdoes, MD, University of Bern

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): September 14, 2017

Study Registration Dates

• First Submitted: November 11, 2015
• First Submitted That Met QC Criteria: November 13, 2015
• First Posted (Estimate): November 16, 2015

Study Record Updates

• Last Update Posted (Actual): September 18, 2017
• Last Update Submitted That Met QC Criteria: September 15, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 193/15