Management of Bleeding in Post-liver Disease, Surgery and Biopsy in Patients With High Uncorrected International Normalized Ratio With Prothrombin Complex Concentrate: An Iranian Experience

Abstract

Background:To evaluate the efficacy of prothrombin complex concentrate (PCC) in the management of bleeding in patients with liver disease and patients undergoing surgery or biopsy who had a high uncorrected international normalized ratio (INR).Objectives:In this study, we examined an Iranian sample and investigated the efficacy of PCC to manage bleeding in patients with liver disease and also patients with high uncorrected INR who were scheduled for surgery or biopsy.Materials and Methods:A total of 25 patients including 16 patients with post-liver disease bleeding (group 1) and 9 patients with high uncorrected INR who were scheduled for surgery or biopsy (group 2) were enrolled. All patients were treated with 25 IU/kg PCC, and efficacy was defined as any reduction in or cessation of bleeding episodes and correction of INR before surgery or biopsy. The patients were also evaluated for any adverse effects.Results:INR decreased significantly in both groups of patients, with no bleeding episodes during or after the study in group 1 and during or after surgery/biopsy in group 2. All patients tolerated the therapy well without any significant adverse effects.Conclusions:The efficacy of PCC therapy was satisfactory in this study. PCC therapy in patients with liver disease and patients undergoing surgery or biopsy seems to be effective and safe, and may be a good treatment strategy for these patients, if fresh frozen plasma or vitamin K are not effective.

Prophylactic fresh frozen plasma versus prothrombin complex concentrate for preprocedural management of the coagulopathy of liver disease: A systematic review

“…Two of the nine eligible studies included both a PCC and FFP group 23,24 . The others were single‐arm studies of FFP ( n = 4) 25‐28 or PCC ( n = 2) 29,30 . In one trial, patients could receive prothrombin complex concentrate and/or fibrinogen based on a rotational thromboelastometry (ROTEM) algorithm 31 .…”

“… 23 , 24 The others were single‐arm studies of FFP ( n = 4) 25 , 26 , 27 , 28 or PCC ( n = 2). 29 , 30 In one trial, patients could receive prothrombin complex concentrate and/or fibrinogen based on a rotational thromboelastometry (ROTEM) algorithm. 31 Seven studies were observational, one was a nonrandomized interventional trial of PCC versus FFP, 23 and one was a randomized controlled trial comparing solvent‐treated versus standard FFP.…”

“…Ochi et al28 described a retrospective multicenter study of 537 patients with coagulopathy secondary to liver disease who were undergoing elective or emergent procedures. A total of 119 patients received FFP before the procedure; 5.0% (6/119) had procedural-related bleeding.Two studies assessed PCC only 29,30. Parand et al29 reported a case series of nine patients with liver disease and an elevated INR, who were scheduled for an unspecified biopsy or other procedure.…”

“…A total of 119 patients received FFP before the procedure; 5.0% (6/119) had procedural-related bleeding.Two studies assessed PCC only 29,30. Parand et al29 reported a case series of nine patients with liver disease and an elevated INR, who were scheduled for an unspecified biopsy or other procedure. All were treated with 25 IU/kg of 4F-PCC.…”

The Use of Kcentra® in the Reversal of Coagulopathy of Chronic Liver Disease

“…2 Three other studies investigated the efficacy of 4F-PCC formulations other than Kcentra (albeit still a 4F-PCC) in patients with CCLD; one study as a reversal prior to liver transplant and two for rapid reversal in life-threatening bleeds. 1,10,23 All 3 studies used formulations of 4F-PCC at a dose of 25 units/kg and concluded that 4F-PCC is safe and effective for the emergent treatment of CCLD when FFP or vitamin K is not an option or fails. 1,10,23 Although these studies demonstrated the applicability and successful use of 4F-PCC, they were limited in that there was no comparative treatment, namely FFP.…”