Fibrinogen and Bleeding After Cardiac Surgery

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00968045

Acronym

Fibro-3

Enrollment

Registered

2009-08-28

Start date

2009-04-30

Completion date

2015-05-31

Last updated

2015-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complications, Bleeding, Coronary Artery Disease

Keywords

Fibrinogen, Postoperative bleeding, Transfusions, CABG

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.

Interventions

DRUGFibrinogen

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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 Clopidogrel and warfarin are withdrawn at least 24 hours before surgery.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

Design outcomes

Primary

Measure	Time frame
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

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

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026