Kinetics of Plasma Fibrinogen in Cardiac Surgery

Completed

• Conditions: Fibrinogens, Abnormal
• Interventions: Procedure: Fibrinogen plasma level

• Registration Number: NCT02605330
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-11-11
• Study First Submitted QC: 2015-11-13
• Study First Posted: 2015-11-16
• Primary Completion: 2016-11
• Status Verified: 2017-09
• Study Completion: 2017-09-14
• Last Update Submitted: 2017-09-15
• Last Update Posted: 2017-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Fibrinogen plasma level in AVR	Fibrinogen plasma level	In all patients undergoing aortic valve replacement (AVR) the investigators plan to measure the fibrinogen plasma level
Fibrinogen plasma level in AAR	Fibrinogen plasma level	In all patients undergoing aortic arch replacement (AAR) the investigators plan to measure the fibrinogen plasma level
Fibrinogen plasma level in CABG	Fibrinogen plasma level	In all patients undergoing coronary artery bypass grafting (CABG) the investigators plan to measure the fibrinogen plasma level

Primary Outcome Measures

Name	Time	Method
Plasma fibrinogen concentration	through study completion, an average of 1 year	Conventional (Clauss) and thromboelastometric measurement (FIBTEM)

Secondary Outcome Measures

Name	Time	Method
Periprocedural thromboembolic complications	through study completion, an average of 1 year
In-hospital mortality	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
Prothrombin time (Quick)	through study completion, an average of 1 year	Measurement of Quick in the laboratory
Thoracic drain loss	through study completion, an average of 1 year	Measurement of the amount of blood collected by the thoracic drain (ml)
Intensive Care Unit (ICU) length of stay	through study completion, an average of 1 year
Thrombin concentration	through study completion, an average of 1 year	Thrombin concentration in the plasma as measured in the laboratory
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

Trial Locations

Locations (1)

University Hospital Bern; 🇨🇭 Bern, Switzerland