Efficacy, Safety, and Strategies for Recombinant Activated Factor VII in Cardiac Surgical Bleeding: a Narrative Review: Recombinant Activated Factor VII in Cardiac Surgical Bleeding

2021 ◽  
Author(s):  
Brent Kidd ◽  
Lauren Sutherland ◽  
Craig S. Jabaley ◽  
Brigid Flynn
Keyword(s):  
Narrative Review ◽  
Factor Vii ◽  
Recombinant Activated Factor Vii ◽  
Activated Factor Vii ◽  
Surgical Bleeding

Change of coagulation after NovoSeven® use for bleeding during cardiac surgery

2017 ◽  
Vol 25 (2) ◽  
pp. 99-104 ◽  
Author(s):  
Emi Tomita ◽  
Hajime Takase ◽  
Keiichi Tajima ◽  
Yoshihiro Suematsu
Keyword(s):  
Cardiovascular Surgery ◽  
International Normalized Ratio ◽  
Factor Vii ◽  
Coagulation System ◽  
Recombinant Activated Factor Vii ◽  
Excessive Bleeding ◽  
Normal Platelet ◽  
Activated Factor Vii ◽  
Normal Ranges ◽  
Surgical Bleeding

Objectives Recombinant activated factor VII has been used for the treatment of hemophilia, factor VII deficiency, and Glanzmann’s thrombasthenia. Off-label uses have recently been increasing, and there are reports that recombinant activated factor VII is effective for the treatment of excessive bleeding during or after cardiovascular surgery. We retrospectively reviewed the effectiveness of recombinant activated factor VII and its influence on the coagulation system as a treatment for uncontrollable bleeding during cardiovascular surgery. Methods Between April 2009 and May 2015, recombinant activated factor VII was used to treat uncontrollable bleeding during cardiovascular surgery in 17 patients at our hospital. The indications for recombinant activated factor VII administration were critical uncontrollable bleeding during surgery and normal platelet and fibrinogen levels. Results Blood loss significantly decreased in every case after recombinant activated factor VII administration ( p < 0.05). No adverse thromboembolic events were encountered. The prothrombin time-international normalized ratio, activated partial thromboplastin time, fibrin degradation product and D-dimer levels decreased significantly after recombinant activated factor VII administration. One day later, all blood coagulation test values were almost within the normal ranges. Conclusions Recombinant activated factor VII has a strong hemostatic action, but it is necessary to exclude surgical bleeding to exhibit the hemostatic effect. Administration that does not comply with the indications for recombinant activated factor VII may lead to serious complications such as thromboembolism. In properly selected patients, recombinant activated factor VII is an effective agent for the treatment of uncontrollable bleeding during cardiovascular surgery.

Validation of the European Practice Guidelines for the Use of Recombinant Activated Factor VII In Patients with Massive Bleeding

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 4744-4744
Author(s):  
Prasad Pillai ◽  
Raghuveer Ranganathan ◽  
Rodina Vatanparast ◽  
Ravindar Reddimallu ◽  
Sarah Lantz ◽  
...  
Keyword(s):  
Cardiac Surgery ◽  
Hemophilia A ◽  
Penetrating Trauma ◽  
Massive Bleeding ◽  
Factor Vii ◽  
Recombinant Activated Factor Vii ◽  
Off Label ◽  
European Guidelines ◽  
Activated Factor Vii ◽  
Surgical Bleeding

Abstract Abstract 4744 Recombinant activated factor VII (rfVIIa) is approved for the treatment of bleeding in patients with hemophilia A or B with inhibitors, congenital factor VII deficiency and Glanzman's thrombasthenia. Since its approval there has been an increase in off-label use of rfVIIa in patients with massive bleeding. In 2006, a European consensus guideline was developed for the use of rfVIIa as an adjunctive therapy for massive bleeding1. The European guidelines recommend using rFVIIa in patients with massive bleeding from blunt trauma, post-partum hemorrhage and uncontrolled post surgical bleeding including cardiac surgery. The guidelines do not recommend use of rfVIIa for penetrating trauma, elective or liver surgery prophylaxis and bleeding in patients with cirrhosis. It is recommended that the efficacy of rfVIIa should be assessed visually and based on transfusion requirements. We conducted a retrospective study in 60 consecutive patient admissions to the Hahnemann University Hospital who were given rfVIIa over the past 2.5 years. The data was analyzed to assess the efficacy according to the clinical indications to validate the European practice guidelines. Details of the results are shown in the table below. In our analysis, use of rfVIIa in patients with inhibitors and uncontrolled post-surgical bleeding including cardiac surgery was effective in achieving hemostasis in an average of 6.4 hours. Conversely in blunt trauma we did not find significant hemostasis. We suspect that this was attributable to the presumed cirrhosis and active anticoagulation therapy in four of the eleven patients. Our study supports the consensus that rfVIIa therapy is not effective in bleeding patients with cirrhosis and penetrating trauma in achieving hemostasis. The average utilization of PRBC/Platelets/FFP in patients with penetrating trauma and cirrhosis were 4.3/0.9/4.2 in comparison with 1.1/0.3/1.0 in patients with inhibitors and uncontrolled peri-operative bleeding including cardiac surgery. The dosing and frequency of rfVIIa was inconsistent, ranging from 60–120 mcg/kg every 2–12 hours and over 1 to 45 days. We observed only one adverse event of venous-thromboembolism at a median follow up of 11 days in the entire group. We conclude that our study validates the efficacy of rfVIIa as an adjunctive therapy for massive bleeding in selected patient populations as recommended in the European guidelines. In addition, there is wide variation in the off-label usage of this product emphasizing the need for a clinical practice guideline for the use of recombinant activated factor VII in the USA. *Diffuse alveolar hemorrhage, Hemorrhage on anticoagulation, AML/MDS with thrombocytopenia, Congenital Hemophilia A, and Type I vWD. 1. Vincent JL, Rossaint R, Riou B, Ozier Y, Zideman D, Spahn DR: Recommendations on the use of recombinant activated factor VII as an adjunctive treatment for massive bleeding – a European perspective, Crit Care 2006, 10:R120. Disclosures: Off Label Use: Recombinant activated factor VIIa (rfVIIa) is approved for the treatment of bleeding in patients with hemophilia A or B with inhibitors, congenital factor VII deficiency and Glanzman's thrombasthenia.

scholarly journals Recombinant activated factor VII in haemostasis after radical nephrectomy

2008 ◽  
Vol 136 (Suppl. 3) ◽  
pp. 259-262
Author(s):  
Petar Jovanovic ◽  
Dragan Ivanovic ◽  
Sladjan Timotijevic ◽  
Sladjana Trpkovic ◽  
Predrag Bojovic ◽  
...  
Keyword(s):  
Cardiac Arrest ◽  
Renal Cell ◽  
Radical Nephrectomy ◽  
Human Factor ◽  
Surgical Intervention ◽  
Factor Viia ◽  
Factor Vii ◽  
Recombinant Activated Factor Vii ◽  
Activated Factor Vii ◽  
Surgical Bleeding

INTRODUCTION. The paper presents important facts in the application of recombinant human factor VIIa (rFVIIa) and in the treatment of renal cell carcer. CASE REPORT. A 69-year old male with infiltrative renal cell carcer underwent radical nephrectomy using Hasagawa`s approach. The extirpated tumor was 35 cm in diameter. During surgery, the patient suffered cardiac arrest with 3500 ml blood loss. Twenty-four hours after operation, he lost additional 2100 ml of blood. Despite adequate blood substitution with intensive surgical attempts to treat haemostasis, bleeding did not stop until the application of rFVIIa (300 IU). The patient survived and fully recovered. CONCLUSION. To control massive non-surgical bleeding additionally complicated by paraneoplastic syndrome, extensive surgical intervention, haemodilution and massive blood substitution, the application of rFVIIa has proved to be most successful.

Local application of recombinant activated factor VII for massive surgical bleeding

2021 ◽  
Vol 85 (3) ◽  
pp. 78
Author(s):  
A.Yu. Lubnin ◽  
D.Yu. Usachev ◽  
A.A. Kurbasov ◽  
A.V. Shmigelsky ◽  
G.I. Gvazava ◽  
...  
Keyword(s):  
Local Application ◽  
Factor Vii ◽  
Recombinant Activated Factor Vii ◽  
Activated Factor Vii ◽  
Surgical Bleeding
Sign in / Sign up

Export Citation Format

Share Document