Fibrinogen and Bleeding After Cardiac Surgery

Coronary Artery Disease Clinical Trial

— Fibro-3  

Official title:

Fibrinogen and Bleeding After Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00968045
• Other study ID #: Fibro 01/07
• Secondary ID: EudraCT-nr:2007-
• Status: Completed
• Phase: Phase 2
• First received: August 27, 2009
• Last updated: May 19, 2015
• Start date: April 2009
• Est. completion date: May 2015

Study information

• Verified date: May 2015
• Source: Sahlgrenska University Hospital, Sweden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products AgencySweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

The study hypothesis is that prophylactic fibrinogen infusion reduces postoperative bleeding and transfusion requirements after coronary artery bypass surgery (CABG) in patients with endogenous fibrinogen levels in the lower normal range. 60 patients will be included in a prospective, randomized double-blind placebo-controlled single center study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: May 2015
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Males and Females

• Age 18 years and above

• Patients eligible for a first-time coronary artery bypass(CABG) surgery with a preoperative fibrinogen plasma concentration under 3,8 g/L

• Signed informed consent to participate in the study

Exclusion Criteria:

• Patients undergoing redo surgery

• Clinical or laboratory signs of bleeding disorder

• Clinical or laboratory signs of significant liver disease, or,other significant disease or condition which in the investigators judgment interfere with hemostasis

• Any medications with agents which may interfere with hemostasis within 14 days prior to study start. Clopidogrel and warfarin are withdrawn at least 24 hours before surgery. Oral aspirin is allowed co-medication.

• Administration of other investigational drugs within eight weeks preceding the preentry examination

• Pregnant or lactating women

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bleeding
• Complications
• Coronary Artery Disease
• Coronary Disease
• Hemorrhage
• Myocardial Ischemia

Intervention

Drug:
• Fibrinogen
Fibrinogen 2 gr in 100 ml sterile water. The infusion is given during 15 minutes

Locations

Country	Name	City	State
Sweden	Cardiothoracic Surgery unit, Sahlgrenska University Hospital	Gothenburg

Sponsors (1)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate safety of prophylactic fibrinogen infusion in patients with fibrinogen levels in the lower normal range undergoing cardiac surgery		2 years	Yes
Primary	Blood loss first 12 postoperative hours		12h	No
Secondary	Transfusions		7 days	No
Secondary	Biomarkers of coagulation, fibrinolysis and platelet function		7 days	No
Secondary	Pharmcoeconomic analysis		2 years	No