Can tromboelastography guide recombinant factor VIIA therapy for refractory hemorrhage after cardiac surgery? An observational study

2008 ◽  
Vol 55 (S1) ◽  
pp. 4754571-4754572
Author(s):  
Massimiliano Meineri ◽  
Marcin Wasowicz ◽  
Stuart McCLuskey ◽  
Nicholas Mitsakakis ◽  
Keyvan Karkouti
Keyword(s):  
Cardiac Surgery ◽  
Observational Study ◽  
Recombinant Factor Viia ◽  
Factor Viia

Recombinant Factor VIIa in the Treatment of Postoperative Hemorrhage After Cardiac Surgery

2005 ◽  
Vol 80 (1) ◽  
pp. 66-71 ◽  
Author(s):  
Peter Raivio ◽  
Raili Suojaranta-Ylinen ◽  
Anne H. Kuitunen
Keyword(s):  
Cardiac Surgery ◽  
Recombinant Factor Viia ◽  
Factor Viia ◽  
Postoperative Hemorrhage

Recombinant Factor VIIa Is Associated With Increased Thrombotic Complications in Pediatric Cardiac Surgery Patients

2017 ◽  
Vol 124 (5) ◽  
pp. 1431-1436 ◽  
Author(s):  
Laura Downey ◽  
Morgan L. Brown ◽  
David Faraoni ◽  
David Zurakowski ◽  
James A. DiNardo
Keyword(s):  
Cardiac Surgery ◽  
Recombinant Factor Viia ◽  
Factor Viia ◽  
Pediatric Cardiac Surgery ◽  
Thrombotic Complications

PRO-PACT: Retrospective observational study on the prophylactic use of recombinant factor VIIa in hemophilia patients with inhibitors

2012 ◽  
Vol 130 (6) ◽  
pp. 864-870 ◽  
Author(s):  
Guy Young ◽  
Guenter Auerswald ◽  
Victor Jimenez-Yuste ◽  
Thierry Lambert ◽  
Massimo Morfini ◽  
...  
Keyword(s):  
Observational Study ◽  
Recombinant Factor Viia ◽  
Factor Viia ◽  
Retrospective Observational Study ◽  
Prophylactic Use

Role Of Recombinant Factor Viia In The Management Of Severe Perioperative Bleeding In Cardiac Surgery, Qatari Experience

2014 ◽  
Author(s):  
Hesham Ahmed Ewila ◽  
Mahmoud Abdallah ◽  
Alejandro Kohn Tuli ◽  
Abdul Rasheed Pattath ◽  
Shaban Mohammed
Keyword(s):  
Cardiac Surgery ◽  
Recombinant Factor Viia ◽  
Factor Viia ◽  
Perioperative Bleeding

Off-Label Use of Recombinant Factor VIIa in United States Hospitals: 2000-2008.

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 67-67
Author(s):  
Aaron C. Logan ◽  
Veronica Yank ◽  
Randall S. Stafford
Keyword(s):  
United States ◽  
Cardiac Surgery ◽  
Hospital Mortality ◽  
Intracranial Hemorrhage ◽  
Recombinant Factor Viia ◽  
Factor Viia ◽  
Off Label Use ◽  
Off Label ◽  
Academic Hospitals ◽  
Label Use

Abstract Abstract 67 Background: Recombinant factor VIIa (rFVIIa) is FDA-approved for treatment of bleeding due to factor VIII or factor IX inhibitors in the setting of congenital or acquired hemophilia or due to congenital factor VII deficiency. When first introduced into clinical practice in 1999, rFVIIa was used predominantly for these labeled indications. Over the years since it became widely available, rFVIIa has been employed extensively for off-label indications. The data to support these uses are sparse or, in some cases, contradictory. Objective: To estimate patterns of off-label rFVIIa use in United States hospitals. Data source: We evaluated data from the Premier Perspectives database of United States hospitals. This representative sample was used to extrapolate national usage patterns of rFVIIa. For each hospitalization at member institutions, the database includes information on patient demographics, primary and secondary diagnoses, medications dispensed, service items used, and disposition at discharge. We examined data encompassing hospitalizations between January 1, 2000 and December 31, 2008. Results: Use of rFVIIa was reported in 235 of 615 hospitals (38%) in the Premier database. 12,644 hospitalizations involving administration of rFVIIa during the study period were identified. Based on statistical weights for each member hospital, this translates to an estimated 73,747 hospitalizations nationwide during which rFVIIa was employed, 18,311 (25%) of which occurred during 2008. Between 2000 and 2008, off-label use of rFVIIa increased more than 140-fold, such that in 2008, 97% of in-hospital indications were off-label. In contrast, in-hospital use for the hemophilias has increased 3.7-fold since 2000 and appears to have plateaued, such that on-label use accounted for only 4.2% of use overall and 2.7% of use in 2008. We found cardiac surgery (29% of use in 2008), trauma (28%), and intracranial hemorrhage (11%) to be the most common off-label indications for rFVIIa use. Consistent with the growth of these and other off-label indications, there has been a significant increase in the mean age of patients receiving rFVIIa from 3 years in 2000 to 59 years in 2008. Conditions with a prominent proportion of use in the elderly (>65 years) included aortic aneurysm (82%), prostatectomy (66%), brain trauma (64%), intracranial hemorrhage (58%), cardiac surgery (57%), and gastrointestinal bleeding (57%). Across all indications, in-hospital mortality has increased substantially over time from 5% in 2000 to 27% in 2008. The highest in-hospital mortality rates were associated with aortic aneurysm (57%), neonatal use (54%), variceal bleeding (51%), other liver disease (49%), liver biopsy (45%), vascular procedures (43%), intracranial hemorrhage (43%), brain trauma (40%), body trauma (36%), and gastrointestinal bleeding (35%). The population receiving rFVIIa for the most common indication, adult cardiac surgery, experienced 24% in-hospital mortality. Amongst all patients treated with rFVIIa in 2008, 43% were discharged to home. Most of the remaining patients were transferred to other facilities, including nursing homes, rehabilitation hospitals, and other acute care facilities. In contrast, hemophilia patients receiving rFVIIa experienced a 3.8% in-hospital mortality rate, while 85% were discharged directly home. Finally, we identified a significant shift in rFVIIa use from academic hospitals (89% in 2000) to non-academic hospitals (67% in 2008). Conclusions: In hospitalized patients, off-label use of rFVIIa far exceeds use for the small number of licensed indications. Cardiac surgery, trauma, and non-traumatic intracranial hemorrhage represent the top indications for in-hospital rFVIIa use in the United States, together accounting for an estimated 12,448 of 18,311 (68%) uses during 2008. Across all off-label indications, in-hospital mortality is high, suggesting a substantial proportion of 'end-stage' use of rFVIIa. Use in such circumstances raises concerns about efficacy, associated adverse events, and allocation of resources. The marked shift in off-label use from academic to non-academic hospitals suggests wide acceptance despite these concerns. These patterns of expanding use are concerning given the absence of strong and consistent evidence to support the off-label application of rFVIIa. Disclosures: Off Label Use: This work characterizes patterns of off-label use of recombinant factor VIIa in United States hospitals..

Recombinant Factor VIIa for Refractory Bleeding After Cardiac Surgery Secondary to Anticoagulation with the Direct Thrombin Inhibitor Lepirudin

2006 ◽  
Vol 26 (4) ◽  
pp. 576-577 ◽  
Author(s):  
Jennifer J Oh ◽  
Wendell S Akers ◽  
Daniel Lewis ◽  
Chand Ramaiah ◽  
Jeremy D Flynn
Keyword(s):  
Cardiac Surgery ◽  
Recombinant Factor Viia ◽  
Factor Viia ◽  
Direct Thrombin Inhibitor ◽  
Thrombin Inhibitor

scholarly journals The role of recombinant factor VIIa in on-pump cardiac surgery: Proceedings of the Canadian Consensus Conference

2007 ◽  
Vol 54 (7) ◽  
pp. 573-582 ◽  
Author(s):  
Keyvan Karkouti ◽  
W. Scott Beattie ◽  
Mark A. Crowther ◽  
Jeannie L. Callum ◽  
Rosaleen Chun ◽  
...  
Keyword(s):  
Cardiac Surgery ◽  
Recombinant Factor Viia ◽  
Factor Viia ◽  
Consensus Conference

148: A COMPARISON OF LOW- AND HIGH-DOSE RECOMBINANT FACTOR VIIA AFTER CARDIAC SURGERY

2020 ◽  
Vol 48 (1) ◽  
pp. 57-57
Author(s):  
Megan Van Berkel Patel ◽  
Lauren Caldwell ◽  
Cimaron Blalock
Keyword(s):  
Cardiac Surgery ◽  
Recombinant Factor Viia ◽  
Factor Viia ◽  
High Dose

Determinants of complications with recombinant factor VIIa therapy in patients with refractory blood loss after cardiac surgery

2006 ◽  
Vol 23 (Supplement 38) ◽  
pp. 3-4
Author(s):  
A. E. Van Rensburg ◽  
M. Meineri ◽  
M. Wasowicz ◽  
K. Karkouti ◽  
S. Beattir
Keyword(s):  
Cardiac Surgery ◽  
Blood Loss ◽  
Recombinant Factor Viia ◽  
Factor Viia

Treatment of Excessive Bleeding in Jehovah's Witness Patients after Cardiac Surgery with Recombinant Factor VIIa (NovoSeven®)

2003 ◽  
Vol 98 (6) ◽  
pp. 1513-1515 ◽  
Author(s):  
Kenichi A. Tanaka ◽  
Amr A. Waly ◽  
William A. Cooper ◽  
Jerrold H. Levy
Keyword(s):  
Cardiac Surgery ◽  
Recombinant Factor Viia ◽  
Factor Viia ◽  
Excessive Bleeding ◽  
Jehovah’S Witness ◽  
Jehovah's Witness
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