• Users Online: 1415
  • Print this page
  • Email this page

 Table of Contents    
Year : 2011  |  Volume : 55  |  Issue : 3  |  Page : 310-311  

Authors' reply

Department of Anaesthesia, Jaslok Hospital and Research Centre, Mumbai, Maharashtra, India

Date of Web Publication7-Jul-2011

Correspondence Address:
Jalpa Makwana
Department of Anaesthesiology, Jaslok Hospital and Research Centre, Mumbai - 400 026, Maharashtra
Login to access the Email id

Source of Support: None, Conflict of Interest: None

PMID: 21808413

Rights and PermissionsRights and Permissions

How to cite this article:
Makwana J, Paranjape S, Goswami J. Authors' reply. Indian J Anaesth 2011;55:310-1

How to cite this URL:
Makwana J, Paranjape S, Goswami J. Authors' reply. Indian J Anaesth [serial online] 2011 [cited 2021 Jan 17];55:310-1. Available from: https://www.ijaweb.org/text.asp?2011/55/3/310/82653


We appreciate the interest of the authors and thank them for their comments [1] regarding our article titled "Antifibrinolytics in Liver Surgery". [2]

We agree with the authors about their views regarding recombinant factor VIIa (rFVIIa). Because our topic of discussion was "Antifibrinolytics in Liver Surgery" and because rFVIIa is not an antifibrinolytic agent, we did not mention it.

However, there are a good number of evidences to prove the efficacy of rFVIIa beyond doubt to control severe bleeding that is refractory to other conventional therapy. But, in spite of different studies and reports including two large, well-conducted, randomized studies, [3],[4] the definite conclusions on the use of rFVIIa during orthotopic liver transplantation (OLT) have yet to be drawn. [5] Prophylactic use of rFVIIa at the beginning of the OLT may reduce the perioperative transfusion requirements in a selected group of patients with prolonged PT and a high Model of End-stage Liver Disease (MELD) score. [6] But, this effect was not found to be very significant. [7] Four randomized controlled trials (RCTs) evaluating the prophylactic administration of rFVIIa during OLT [3],[4],[7],[8] demonstrated no difference in mortality or thromboembolic adverse events except in one trial, which showed a reduction in RBC transfusion requirements (300 mL±133 in the rFVIIa group vs. 570 mL±111 in the control group; P<0.017). [7] Although rFVIIa is a very effective procoagulant, there is always a concern about hepatic artery thrombosis, which is a dreadful complication during OLT. Recently, Levi et al. studied a large and comprehensive cohort of persons in placebo-controlled trials of rFVIIa from 35 RCTs involving 4468 subjects and found that the rate of thromboembolic events among rFVIIa users was 11.1% (498 of 4468 subjects). They also observed that the rate of arterial thromboembolic events was higher among those who received rFVIIa than in those receiving placebo (5.5% vs. 3.2%), whereas the rate of venous thromboembolism was almost similar to placebo (5.3% vs. 5.7%). [9]

Consensus recommendations for the off-label use of rFVIIa were published by a multidisciplinary panel convened jointly by the Society for the Advancement of Blood Management and the University HealthSystem Consortium. [10] Rescue therapy with rFVIIa was deemed appropriate for patients with uncontrolled bleeding in the setting of cardiac, aortic, hepatic, or orthopaedic surgery if they failed to achieve haemostasis with significant clotting factor replacement (20 mL/kg or 6 units of fresh frozen plasma, 6 units of platelets twice for platelet counts less than 50,000, and/or 10 bags of cryoprecipitate twice when fibrinogen is low). [10],[11]

Therefore, on the basis of the current literature, there is no evidence to support an extensive use of rFVIIa. It appears that there is a consensus that rFVIIa can be used with good results as a rescue therapy in extremely severe bleeding situations based on individual clinical conditions and patient risk/benefit profile. [12],[13],[14],[15]

   References Top

1.Bhatia P. Use of recombinant factor VIIa in orthotopic liver transplant. Indian J Anaesth 2011;55:309-10.  Back to cited text no. 1
  Medknow Journal  
2.Makwana J, Paranjape S, Goswami J. Antifibrinolytics in liver surgery. Indian J Anaesth 2010;54:489-95.  Back to cited text no. 2
[PUBMED]  Medknow Journal  
3.Lodge JP, Jonas S, Jones RM, Olausson M, Mir-Pallardo J, Soefelt S, et al. Efficacy and safety of repeated perioperative doses of recombinant factor VIIa in liver transplantation. Liver Transpl 2005;11:973-9.  Back to cited text no. 3
4.Planinsic RM, Van der Meer J, Testa G, Grande L, Candela A, Porte RJ, et al. Safety and efficacy of a single bolus administration of recombinant factor VIIa in liver transplantation due to chronic liver disease. Liver Transpl 2005;11:895-900.  Back to cited text no. 4
5.Gasperi AD, Baudo F. Use of recombinant factor VIIa during orthotopic liver transplantation. Liver Transpl 2006;12:1176-7.  Back to cited text no. 5
6.Niemann CU, Behrends M, Quan D, Eilers H, Gropper MA, Roberts JP, et al. Recombinant factor VIIa reduces transfusion requirements in liver transplant patients with high MELD scores. Transfus Med 2006;16:93-100.  Back to cited text no. 6
7.Pugliese F, Ruberto F, Summonti D, Perrella S, Cappannoli A, Tosi A, et al. Activated recombinant factor VII in orthotopic liver transplantation. Transplant Proc 2007;39:1883-5.  Back to cited text no. 7
8.Liu JP, Chen T, Wang J, Al E. Hemorrhagic features and the application of recombinant activated factor VII in liver transplantation. J Clin Rehabil Tissue Eng Res 2009;13:3580-4.  Back to cited text no. 8
9.Levi M, Levy JH, Andersen HF, Truloff D. Safety of recombinant activated factor VII in randomized clinical trials. N Engl J Med 2010;363:1791-800.   Back to cited text no. 9
10.Shander A, Goodnough LT, Ratko T, Matuszewski KA, Cohn S, Diringer M, et al. Consensus recommendations for the off-label use of recombinant human factor VIIa (NovoSeven) therapy. Pharm Ther 2005;30:644-58.  Back to cited text no. 10
11.Logan AC, Goodnough LT. Recombinant factor VIIa: An assessment of evidence regarding its efficacy and safety in the off-label setting. consultative hematology: Hemostasis and thrombosis Available from: http://asheducationbook.hematologylibrary.org/cgi/content/full/2010/1/1532010. [accessed on 2011 Feb 25].  Back to cited text no. 11
12.Viana JS. Recombinant factor VIIa in major abdominal surgery and liver transplantation. Transplant Proc 2006;38:818-9.  Back to cited text no. 12
13.Squizzato A, Ageno W. Recombinant activated factor VII as a general haemostatic agent: evidence-based efficacy and safety. Curr Drug Saf 2007;2:155-61.  Back to cited text no. 13
14.Cozzi P, Chiumello D, Tubiolo D, Sicignano A, Brandi G, Bianchi P, et al. Total hepatectomy, recombinant activated factor VII and rescue liver transplantation. Minerva Anestesiol 2010;76:550-3.  Back to cited text no. 14
15.Gala B, Quintela J, Aguirrezabalaga J, Fernández C, Fraguela J, Suárez F, et al. Benefits of recombinant activated factor VII in complicated liver transplantation. Transplant Proc 2005;37:3919.  Back to cited text no. 15


    Similar in PUBMED
   Search Pubmed for
   Search in Google Scholar for
    Access Statistics
    Email Alert *
    Add to My List *
* Registration required (free)  

  In this article

 Article Access Statistics
    PDF Downloaded239    
    Comments [Add]    

Recommend this journal