Kinetics of Plasma Fibrinogen in Cardiac Surgery

Fibrinogens, Abnormal Clinical Trial

Official title:

Kinetics of Plasma Fibrinogen During Cardiac and Thoracic Aortic Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02605330
• Other study ID #: 193/15
• Status: Completed
• Phase: N/A
• First received: November 11, 2015
• Last updated: September 15, 2017
• Start date: November 2015
• Est. completion date: September 14, 2017

Study information

• Verified date: September 2017
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: September 14, 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibrinogens, Abnormal

Intervention

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.

Locations

Country	Name	City	State
Switzerland	University Hospital Bern	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma fibrinogen concentration	Conventional (Clauss) and thromboelastometric measurement (FIBTEM)	through study completion, an average of 1 year
Secondary	Periprocedural thromboembolic complications		through study completion, an average of 1 year
Secondary	Thoracic drain loss	Measurement of the amount of blood collected by the thoracic drain (ml)	through study completion, an average of 1 year
Secondary	In-hospital mortality		through study completion, an average of 1 year
Secondary	Intensive Care Unit (ICU) length of stay		through study completion, an average of 1 year
Secondary	Platelet count	Measurement of platelet count in the laboratory	through study completion, an average of 1 year
Secondary	Prothrombin time (Quick)	Measurement of Quick in the laboratory	through study completion, an average of 1 year
Secondary	Activated partial thromboplastin time (aPTT)	Measurement of aPTT in the laboratory	through study completion, an average of 1 year
Secondary	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
Secondary	Thrombin concentration	Thrombin concentration in the plasma as measured in the laboratory	through study completion, an average of 1 year