Fibrinogen and Bleeding After Cardiac Surgery

Phase 2

Completed

• Conditions: Complications; Bleeding; Coronary Artery Disease
• Interventions: Drug: Fibrinogen

• Registration Number: NCT00968045
• Lead Sponsor: Sahlgrenska University Hospital, Sweden

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-08-27
• Study First Submitted QC: 2009-08-27
• Study First Posted: 2009-08-28
• Primary Completion: 2012-02
• Status Verified: 2015-05
• Study Completion: 2015-05
• Last Update Submitted: 2015-05-19
• Last Update Posted: 2015-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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 Clopidogrel and warfarin are withdrawn at least 24 hours before surgery.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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Fibrinogen	100 ml infusion of saline is given during 15 minutes after anesthesia induction before start of surgery.
Study drug	Fibrinogen	Fibrinogen 2g in 100 ml sterile water given during 15 minutes after anestesiainduction before surgery start

Primary Outcome Measures

Name	Time	Method
To evaluate safety of prophylactic fibrinogen infusion in patients with fibrinogen levels in the lower normal range undergoing cardiac surgery	2 years
Blood loss first 12 postoperative hours	12h

Secondary Outcome Measures

Name	Time	Method
Transfusions	7 days
Biomarkers of coagulation, fibrinolysis and platelet function	7 days
Pharmcoeconomic analysis	2 years

Trial Locations

Locations (1)

Cardiothoracic Surgery unit, Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Sweden