Replies to post #8490 on GTC Biotherapeutics (fka GTCB)

[DewDiligence]

rFVIIa in Cardiac Surgery: Experience from the
Australian and New Zealand Haemostasis Registry

http://tinyurl.com/2cg8b6

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Ann Thorac Surg. 2008 Mar;85(3):836-44

Dunkley S, Phillips L, McCall P, Brereton J, Lindeman R, Jankelowitz G, Cameron P.

Royal Prince Alfred Hospital, Sydney, New South Wales, Australia.

BACKGROUND: Data from the Australian and New Zealand Haemostasis Registry (ANZHR) were used to report on the efficacy, mortality, and outcomes of a cohort of cardiac surgical cases receiving recombinant activated factor VII (rFVIIa).

METHODS: The ANZHR collects retrospective and contemporaneous data on the use of rFVIIa in patients with critical bleeding from hospitals throughout Australia and New Zealand. Participating centers commit to the collection of data on all patients without hemophilia treated with rFVIIa, which limits bias and prevents the reporting of only positive or anecdotal experiences.

RESULTS: At September 2006, the cardiac surgical cohort comprised 304 patients (43%) of a total of 695 cases reported to the ANZHR from 46 hospitals. The 304 cases date from January 2001. The median patient age was 66 years (interquartile range [IQR], 53 to 75 years), and 73% were men. After administration of rFVIIa, all blood product usage was significantly reduced. Patients received a median dose of 93 mug/kg (IQR, 82 to 102), and 85% of patients received a single dose. The documented response rate to a single dose of rFVIIa was 84%, of which 23% reported cessation of bleeding and 61% reported a reduction in bleeding. Patients received a median volume of 6 U of red blood cells before rFVIIa treatment. The median reduction in red blood cells after the rFVIIa dose compared with before was 4 U. Response was reduced in patients with a lower baseline hemoglobin, coagulopathy (determined by international normalized ratio, fibrinogen, and platelets), the number of red blood cell units transfused before rFVIIa, advanced age, more complex operations, hypothermia, and acidosis. Responders had a significantly reduced mortality (p < 0.001). The percentage of patients alive at 28 days was 95% if bleeding ceased after rFVIIa, 86% if bleeding reduced, and 60% for nonresponders. A 7% adverse event rate attributed as "probably" or "possibly" associated with rFVIIa was reported with a 4% reported thromboembolic event rate.

CONCLUSIONS: Recombinant FVIIa is a potential rescue therapy in severe uncontrollable critical bleeding after cardiac operations. The observed response rate was high, and response was associated with improved mortality. There was an observed reduction in blood product usage after rFVIIa. The adverse event rate reported was similar to documented adverse event rates in complex cardiac surgical patients. In the absence of randomized controlled trials, this registry provides a basis for understanding current clinical practice with rFVIIa in cardiac surgical procedures.
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[DewDiligence]

Reference List of rFVIIa Papers

[Added miscellaneous abstracts.]


Prophylactic use in hereditary hemophilia
#msg-25160331von Willebrand disease
#msg-22471666
#msg-19404190
#msg-15650473


Acquired hemophilia
#msg-27452658 Australia/New Zealand registry
#msg-26121985 Postpartum hemorrhage (European registry)
#msg-24267861 Negative review from Italy
#msg-23278399 Reversing effects of anticoagulants
#msg-23666744 Postpartum hemorrhage
#msg-21829544 CABG
#msg-19965112 Aortic Dissection
#msg-18991424 Meta-analysis in acquired hemophilia
#msg-16035848 Pediatric hemorrhage
#msg-16035824 CABG
#msg-15749216 Hepatic trauma
#msg-15679338 Reversing Plavix bleeding
#msg-14833495 Postcardiotomy bleeding
#msg-13784060 Reversing Lepirudin (Refludan) bleeding


Trauma and military settings
#msg-27464741
#msg-24304079 Profile of chief military surgeon
#msg-22196042
#msg-19667761
#msg-15971893
#msg-14921693
#msg-13925693


Intracerebral hemorrhage
#msg-19364652 Review
#msg-15742148 Non-surgical ICH
#msg-15122036
#msg-14833043
#msg-14634515


Economic analysis
#msg-27139814
#msg-26421408 Prevention of joint damage
#msg-16326768
#msg-16169770
#msg-15971893
#msg-15063643


Miscellaneous
Everything you wanted to know about FVIIa in practice
#msg-25220261 FVIIa FoB’s (highly technical)
#msg-22375431 FVIII+FVIIa combination therapy
#msg-14700217 FVIIa analogs
#msg-14673432 Titration method