Fresh Frozen Plasma Transfusion before Invasive Procedure in Patients with Cirrhosis and Severe ‎Coagulopathy‎ ‎

INTRODUCTION

Bleeding is a featured complication in cirrhotic patients with significant coagulopathy [1,2]. ‎Coagulopathy, as defined by deranged conventional coagulation tests, international normalized ratio ‎‎(INR), and activated partial thromboplastin time (aPTT), is directly related to the severity of ‎cirrhosis. Guidelines have recommended the correction of coagulation test (INR, aPTT) through the ‎use of fresh frozen plasma (FFP) before invasive procedures to prevent bleeding [3,4]. ‎Consequently, FFP is frequently transfused before the invasive procedure in patients with advanced ‎decompensated cirrhosis and a deranged coagulation test to reduce presumed high bleeding risk ‎‎[5,6]. This practice was traced by a British study that reported that 30% of the patients with cirrhosis ‎were transfused with FFP; furthermore, 24 to 48 % of the transfused plasma in the United States was ‎prophylactically requested for patients undergoing an invasive procedure [7,8]. However, clinical ‎evidence is still scarce for this practice [8,9]. This work aimed to assess the efficacy of prophylactic ‎FFP transfusion before the invasive procedures in patients with cirrhosis and severe coagulopathy‎.

PATIENTS‎ AND METHODS

This randomized pilot study enrolled 42 adult patients with cirrhosis and deranged coagulation test (INR ≥ 2) who was planned to have an invasive procedure. The patients were recruited from the hospitalized or endoscopy list of the Nizwa General Hospital, Ministry of Health, Sultanate of Oman from  July 2021 to January 2022. Cirrhosis was‎ diagnosed on clinical, laboratory, imaging, and/or histology.

Exclusion criteria: Platelet count ≤ 50000/ul, anticoagulant or antiplatelet medications, ongoing bleeding, congenital or acquired coagulation disorder unresponsive to FFP transfusion, previous or current thromboembolic event sepsis and hemodialysis n last seven days, preexisting heart failure or acute lung injury. After informed consent, patients were randomly distributed to 1:1 rato to receive FPP transfusion (group A) or no transfusion (group B). FFP was entirely transfused within 6 hours before a procedure at a dose of 10 cc per kg (maximum five units) with concomitant diuretic administration as needed per the attending physician. Demographic and clinical characters were recorded, and routine blood chemistry was performed. Post-procedure; the patients were clinically re-examined daily after the procedures, recording any bleeding if it occurred. INR and hemoglobin levels were done daily for two days post-procedure. The following outcomes were traced; 

Pre-procedure:

-       Mean INR levels before and after FFP transfusion.

-       Transfusion side effects within 6 hours, e.g., new heart failure or acute lung injury.

Post-procedure:

-       Occurrence of bleeding either overt, hemoglobin drop requiring transfusion for target hemoglobin goal of 7-8 g/dl, or significant hemoglobin drop more than 2 gm from the pre-procedure level within the next two days after the procedure.

-       Mean change INR levels for the following two days after the procedure.

-       Mean difference of hemoglobin and INR levels from the pre-procedure level to the least in the next two days after the procedure.

Data analysis

The data were analyzed using SPSS (IBM SPSS Statistics 28.0, United States). Mean and standard deviation (SD) was used for summarizing quantitative data, and a t-test was conducted for their significance assessment. Number and percentages were used to summarize qualitative data, while Chi-square and Fisher's exact test was conducted for their significance assessment. A P value of < 0.05 was statistically significant. 

RESULTS:

The enrolled 42 patients in the study had a mean age of 58 ± 18, 71% were men, and 29% were female. There was no significant difference between the two groups in the pre-procedure characters (body weight, etiology of cirrhosis, MELD score, CTP score, and class). Patients with a CTP class C represented 54.7 % of the study population. Two patients had transfusion-related adverse effects in the form of volume overload and could be managed by diuretics. On the other side, three patients had procedure-related bleeding (2 group B with a significant hemoglobulin drop of ≥ 2 gm and one in group A without a significant hemoglobulin drop) (table 1). Paracentesis was the most common procedure (38.1%), esophageal varices band ligation (19.05%), as shown in table 2. Table 3 showed no significant difference in the pre-procedure INR level between the two groups before randomization (2.26 ± 0.2 and 2.31 ± 0.22 respectively). However, the pre-procedure change of INR in group A after FFP transfusion was significantly higher than in group B (- 0.38 ± 0.22 and - 0.02 ± 0.08 respectively) and continued over the consecutive two days post-procedure. There was no significant difference in the pre-procedure hemoglobulin level between the two groups and no significant difference in post-procedure hemoglobulin level change to the lowest within the two consecutive days.

CHCV; chronic hepatitis C virus. CHBV; chronic hepatitis B virus. MELD; model of end-stage liver disease..

CTP; Child-Turcotte-Pugh.

Table (2):Procedure type and distribution between the two groups.

*Fisher´s exact test. P < 0.05 is significant.

Table (3):  Pre-procedure and Post-Procedure INR and HGB  levels

* t-test p value (significant < 0.05). HGB; hemoglobulin. INR: international normalized ratio.SD; standard deviation

DISCUSSION