Phase 3
Completed N=62
Prospective Double Blinded Randomized Control Study of the Use of Fibrinogen in High-Risk Cardiac Surgery
Cardiac Complication During Procedure
Source: ClinicalTrials.gov NCT01623531 ↗
Enrolled (actual)
62
Serious AEs
25.0%
Results posted
May 2020
Primary outcomePrimary: Cumulative Transfusion Units — 0; 0 Transfusion Units — p=.908
◆ Published Evidence
Emerging
▲ Trending
12citations · ~2 / year
The prophylactic use of fibrinogen concentrate in high-risk cardiac surgery.
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.
Linked Publications
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The prophylactic use of fibrinogen concentrate in high-risk cardiac surgery.
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 |
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
Data sourced from ClinicalTrials.gov (NCT01623531) and the linked publication. 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. Informational only — not medical advice.