Phase 3 N=62 Randomized Triple-blind Treatment

Prospective Double Blinded Randomized Control Study of the Use of Fibrinogen in High-Risk Cardiac Surgery

Cardiac Complication During Procedure

Bottom Line

View on ClinicalTrials.gov: NCT01623531 ↗

Enrolled (actual)

Serious AEs

25.0%

Results posted

May 2020

Primary outcome: Primary: Cumulative Transfusion Units — 0; 0 Transfusion Units — p=.908

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Fibrinogen (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Nova Scotia Health Authority
Primary completion: Mar 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Cumulative Transfusion Units	0; 0	.908
SECONDARY Fibrinogen Plasma Concentration (g/L)	4.65; 4.15	.047 sig
SECONDARY Hematocrit (%)	0.29; 0.28	.729
SECONDARY Hemoglobin Concentration (g/L)	95; 95	.93
SECONDARY Platelet Count (10^3/μL)	129; 117	.169
SECONDARY Partial Thromboplastin Time (s)	31; 28.5	.035 sig
SECONDARY International Normalized Ratio	1.2; 1.2	.794
SECONDARY Prothrombin Time (s)	13.9; 13.8	.828
SECONDARY EXTEM Clotting Time (s)	68; 68	.941
SECONDARY EXTEM Maximum Clot Firmness (mm)	66; 64	.09
SECONDARY INTEM Clotting Time (s)	161; 164	.658
SECONDARY INTEM Maximum Clot Firmness (mm)	64; 63	.182
SECONDARY FIBTEM Clotting Time (s)	64; 59	.549
SECONDARY FIBTEM MCF (Maximum Clot Firmness)	27; 23	.022 sig
SECONDARY HEPTEM Clotting Time (s)	162; 162	.455
SECONDARY HEPTEM Maximum Clot Firmness (mm)	62; 61	.5
SECONDARY Total Avoidance of Transfusions	20; 21; 7; 8	1.0

Summary

The aim of the study is to show that first line treatment with concentrated fibrinogen has superiority over the conventional therapy with fresh frozen plasma (FFP), platelets, and cryoprecipitate in perioperative management of bleeding after complex cardiac surgery.

Eligibility Criteria

Inclusion Criteria

All patients who are scheduled for elective complex cardiac surgical procedures including

double procedures (aortic valve replacement (AVR)+CABG, mitral valve repair/replacement (MVR)+CABG, AVR+MVR)
Redo-sternotomies
Aortic root repair +/- AVR

Exclusion Criteria

Any known congenital or pre-existing bleeding disorder
pre-existing clinically significant abnormal fibrinogen level (normal: 2.5-4.79g/l)
severe liver disease (alanine aminotransferase or aspartate aminotransferase > 150 U/l)
inability to provide informed consent
emergency surgery
pregnancy or nursing
age under 18 years
intake of anti-platelet drugs within2- 5 days preoperatively (low dose ASA is allowed)
allergy to concentrated fibrinogen or other components in the product
anemia (Hgb < 110)
diagnosed deep vein thrombosis (DVT)
pulmonary embolism
acute stroke
acute myocardial infarction

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01623531). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.