-
1.
Comparative Efficacy of Early TIPS, Non-Early TIPS, and Standard treatment in patients with cirrhosis and acute variceal bleeding: a network meta-analysis
Huang, Y., Wang, X., Li, X., Sun, S., Xie, Y., Yin, X.
International journal of surgery (London, England). 2023
-
-
-
Free full text
-
-
Editor's Choice
Abstract
BACKGROUND Cirrhosis is a chronic disease characterized by chronic liver inflammation and diffuse fibrosis. A combination of vasoactive drugs, preventive antibiotics, and endoscopy is the recommended standard treatment for patients with acute variceal bleeding; however, this has been challenged. We compared the effects of early transjugular intrahepatic portosystemic shunt (TIPS), non-early TIPS, and standard treatment in patients with cirrhosis and acute variceal bleeding. MATERIALS AND METHODS The present network meta-analysis was conducted in accordance with the criteria outlined in the Preferred Reporting Items for Systematic Reviews and Meta-Analyses and Assessing the methodological quality of systematic reviews guidelines. The review has been registered with the International Prospective Register of Systematic Reviews. The PubMed, Embase, Cochrane Library, ClinicalTrials.gov, and World Health Organization-approved trial registry databases were searched for randomized controlled trials (RCTs) evaluating early TIPS, non-early TIPS, and standard treatment in patients with cirrhosis and acute variceal bleeding. RESULTS Twenty-four RCTs (1,894 patients) were included in the review. Compared with standard treatment, early TIPS (odds ratio [OR], 0.53; 95% credible interval [CrI], 0.30-0.94; surface under the cumulative ranking curve [SUCRA], 98.3) had a lower risk of all-cause mortality (moderate-to-high-quality evidence), and early TIPS (OR, 0.19; 95% CrI, 0.11-0.28; SUCRA, 98.2) and non-early TIPS (OR, 0.30, 95% CrI: 0.23-0.42; SUCRA, 1.8) were associated with a lower risk of rebleeding (moderate-to-high-quality evidence). Early TIPS was not associated with a reduced risk of hepatic encephalopathy, and non-early TIPS (OR, 2.78; 95% CrI, 1.89-4.23, SUCRA, 0) was associated with an increased incidence of hepatic encephalopathy (moderate-to-high-quality evidence). There was no difference in the incidence of new or worsening ascites (moderate-to-high-quality evidence) among the three interventions. CONCLUSION Based on the moderate-to-high quality evidence presented in this study, early TIPS placement was associated with reduced all-cause mortality [with a median follow-up of 1.9 years (25th-75th percentile range 1.9-2.3 years)] and rebleeding compared to standard treatment and non-early TIPS. Although early TIPS and standard treatment had a comparable incidence of hepatic encephalopathy, early TIPS showed superiority over non-early TIPS in this aspect. Recent studies have also shown promising results in controlling TIPS-related hepatic encephalopathy. However, it is important to consider individual patient characteristics and weigh the potential benefits against the risks associated with early TIPS. Therefore, we recommend that clinicians carefully evaluate the patient's condition, considering factors such as severity of variceal bleeding, underlying liver disease, and overall clinical status, before making a treatment decision. Further well-designed RCTs comparing early TIPS with non-early TIPS are needed to validate these findings and provide more definitive guidance.
PICO Summary
Population
Patients with cirrhosis and acute variceal bleeding (24 randomised controlled trials, n= 1,894).
Intervention
Early transjugular intrahepatic portosystemic shunt (TIPS).
Comparison
Non-early TIPS. Standard treatment.
Outcome
Compared with standard treatment, early TIPS (odds ratio (OR) 0.53; 95% credible interval (CrI), [0.30, 0.94]; surface under the cumulative ranking curve [SUCRA], 98.3) had a lower risk of all-cause mortality (moderate-to-high-quality evidence), and early TIPS (OR, 0.19; 95% CrI [0.11, 0.28]; SUCRA, 98.2) and non-early TIPS (OR, 0.30; 95% CrI [0.23, 0.42]; SUCRA, 1.8) were associated with a lower risk of rebleeding (moderate-to-high-quality evidence). Early TIPS was not associated with a reduced risk of hepatic encephalopathy, and non-early TIPS (OR 2.78; 95% CrI [1.89, 4.23] SUCRA, 0) was associated with an increased incidence of hepatic encephalopathy (moderate-to-high-quality evidence). There was no difference in the incidence of new or worsening ascites (moderate-to-high-quality evidence) among the three interventions.
-
2.
Rotational thromboelastometry guided blood component use in cirrhotic children undergoing invasive procedures: Randomized Controlled Trial
Maria A, Lal BB, Khanna R, Sood V, Mukund A, Bajpai M, Alam S
Liver international : official journal of the International Association for the Study of the Liver. 2022
-
-
-
-
Editor's Choice
Abstract
BACKGROUND & AIMS This randomized controlled trial (RCT) was conducted with the aim to evaluate the efficacy and safety of using ROTEM-based transfusion strategy in cirrhotic children undergoing invasive procedures. METHODS This was a open-label, RCT which included (i) children under 18 years of age with liver cirrhosis; (ii) INR between 1.5 and 2.5; and/or (iii) platelet count between 20x10(9) /L to 50x10(9) /L (for procedures other than liver biopsy) and between 40x10(9) /L to 60x10(9) /L (for liver biopsy); and (iv) listed for invasive procedures. Stratified randomization was done for children undergoing liver biopsies. Patients randomized to the ROTEM and conventional groups received blood component transfusion using predefined criteria. RESULTS A total of 423 invasive procedures were screened for inclusion of which 60 were randomized (30 in each group with comparable baseline parameters). The volume of total blood components, fresh frozen plasma (FFP) and platelets transfused was significantly lower in ROTEM as compared to conventional group. Only 46.7% of children in ROTEM group received a blood component compared to 100% in conventional group (p<0.001). The requirement of FFP (ROTEM 43.3%, Conventional: 83.3%, p = 0.001) was significantly lower in the patients receiving ROTEM guided transfusions. There was no difference in procedure related bleed and transfusion related complications between the 2 groups. ROTEM was cost effective (p=0.002) despite the additional cost of the test. CONCLUSION ROTEM-based transfusion strategies result in lower blood component transfusion in cirrhotic children undergoing invasive procedures without an increase in risk of procedure-related bleed. ROTEM-guided transfusion strategy is cost-effective.
PICO Summary
Population
Children with liver cirrhosis undergoing invasive procedures (n= 60).
Intervention
ROTEM-based transfusion strategy (n= 30).
Comparison
Conventional coagulation tests-based transfusion strategy (n= 30).
Outcome
The volume of total blood components, fresh frozen plasma (FFP) and platelets transfused was significantly lower in ROTEM as compared to conventional group. Only 46.7% of children in ROTEM group received a blood component compared to 100% in conventional group. The requirement of FFP (ROTEM: 43.3%, conventional: 83.3%) was significantly lower in the patients receiving ROTEM guided transfusions. There was no difference in procedure related bleed and transfusion related complications between the two groups. ROTEM was cost-effective despite the additional cost of the test.
-
3.
A double-blind randomized placebo-controlled trial of albumin in patients with hepatic encephalopathy: HEAL study
Fagan A, Gavis EA, Gallagher ML, Mousel T, Davis B, Puri P, Sterling RK, Luketic VA, Lee H, Matherly SC, et al
Journal of hepatology. 2022
-
-
-
Full text
-
Editor's Choice
Abstract
BACKGROUND AND AIMS Even after recovery from overt hepatic encephalopathy (HE), minimal HE (MHE), which impairs quality of life (QOL), can persist. Treatment options are limited. AIM: Determine the impact of albumin versus saline on MHE and QOL in patients with prior HE already on standard of care using double-blind, placebo-controlled randomized clinical trial. METHODS Outpatients with cirrhosis and prior HE, MHE and hypoalbuminemia already on HE-treatment were included. Patients on regular IV albumin infusions were excluded. Subjects were randomized 1:1 to receive either weekly infusions of 25% IV albumin 1.5g/kg or saline over 5 weeks (end-of-drug,EOD) and then 1-week post-infusion (end-of-study,EOS). MHE was defined using either Psychometric hepatic encephalopathy score (PHES), Stroop or Critical clicker frequency. MHE and QOL using Sickness Impact profile (SIP total, physical, psychosocial domain, higher=worse) and serum (inflammation, endothelial dysfunction, and ischemia-modified albumin IMA) were compared between baseline, EOD and EOS. RESULTS 48(24/group) subjects were randomized and were balanced at baseline, including HE-medication use. Adverse events were similar, with MELD and ammonia remaining stable between/within groups. Albumin levels increased and IMA decreased only in the albumin group at EOD and EOS vs baseline. PHES and Stroop MHE reversal and improvement was greater in albumin group at EOD and persisted at EOS. SIP total and psychosocial, but not physical domain improved in the albumin but not placebo group versus baseline at EOD and EOS along with significant reduction in IL-1β, and endothelial dysfunction markers. CONCLUSION In a double-blind, placebo controlled RCT of outpatients with cirrhosis, prior HE and current MHE, albumin infusions were associated with improved cognitive function and psychosocial quality of life likely through amelioration of endothelial dysfunction. LAY SUMMARY Patients who have liver cirrhosis often develop confusion that can result in difficulty thinking and processing information, which can negatively impact their quality of life. We performed a clinical trial of weekly injections of albumin (a protein normally made by the liver, and which is low in cirrhosis) and placebo in patients with cirrhosis and persistent brain problems and found that those who received albumin did better on their brain function and quality of life compared to those who received placebo. Albumin injections were also associated with reduction in inflammation and other blood factors that could potentially be a mechanism of this benefit.
PICO Summary
Population
Patients with hepatic encephalopathy enrolled in the HEAL study (n= 48).
Intervention
Albumin (n= 24).
Comparison
Saline (n= 24).
Outcome
Adverse events were similar, with MELD and ammonia remaining stable between/within groups. Albumin levels increased and ischemia-modified albumin decreased only in the albumin group at end-of-drug and end-of-study vs. baseline. Psychometric hepatic encephalopathy score and Stroop minimal hepatic encephalopathy reversal and improvement was greater in albumin group at end-of-drug and persisted at end-of-study. Sickness impact profile total and psychosocial, but not physical domain improved in the albumin but not placebo group vs. baseline at end-of-drug and end-of-study along with significant reduction in IL-1β, and endothelial dysfunction markers.
-
4.
Thromboelastography-Guided Therapy Enhances Patient Blood Management in Cirrhotic Patients: A Meta-analysis Based on Randomized Controlled Trials
Hartmann J, Dias JD, Pivalizza EG, Garcia-Tsao G
Seminars in thrombosis and hemostasis. 2022
-
-
-
Free full text
-
Full text
-
Editor's Choice
Abstract
Patients with cirrhosis often have abnormal hemostasis, with increased risk of hemorrhage and thrombosis. Thromboelastography provides a rapid assessment of the coagulation status and can guide product transfusions in adult patients with cirrhosis. This study aimed to determine whether the use of thromboelastography in adult patients with cirrhosis decreases blood product use and impacts adverse events or mortality compared with standard practice. A registered (PROSPERO CRD42020192458) systematic review and meta-analysis was conducted for randomized controlled trials (RCTs) comparing thromboelastography-guided hemostatic management versus standard practice (control). Co-primary outcomes were the number of transfused platelet units and fresh frozen plasma (FFP) units. Secondary outcomes were mortality, adverse events, utilization of individual blood products, blood loss or excessive bleeding events, hospital/intensive care unit stay, and liver transplant/intervention outcomes. The search identified 260 articles, with five RCTs included in the meta-analysis. Platelet use was five times lower with thromboelastography versus the control, with a relative risk of 0.17 (95% confidence interval [CI]: [0.03-0.90]; p = 0.04), but FFP use did not differ significantly. Thromboelastography was associated with less blood product (p < 0.001), FFP + platelets (p < 0.001), and cryoprecipitate (p < 0.001) use. No differences were reported in bleeding rates or longer term mortality between groups, with the thromboelastography group having lower mortality at 7 days versus the control (relative risk [95% CI] = 0.52 [0.30-0.91]; p = 0.02). Thromboelastography-guided therapy in patients with cirrhosis enhances patient blood management by reducing use of blood products without increasing complications.
PICO Summary
Population
Patients with cirrhosis (5 studies, n= 302).
Intervention
Thromboelastography-guided haemostatic management.
Comparison
Standard coagulation testing (standard practice).
Outcome
Platelet use was five times lower with thromboelastography vs. standard practice, with a relative risk of 0.17 (95% confidence interval [CI]: [0.03-0.90]), but fresh frozen plasma (FFP) use did not differ significantly. Thromboelastography was associated with less blood product, FFP + platelets, and cryoprecipitate use. No differences were reported in bleeding rates or longer-term mortality between groups, with the thromboelastography group having lower mortality at 7 days vs. standard practice (relative risk [95% CI] = 0.52 [0.30-0.91]).
-
5.
Low-dose continuous terlipressin infusion is effective and safer than intravenous bolus injections in reducing portal pressure and control of acute variceal bleeding
Arora V, Choudhary SP, Maiwall R, Vijayaraghavan R, Jindal A, Kumar G, Sarin SK
Hepatology international. 2022
-
-
-
Full text
-
Editor's Choice
Abstract
BACKGROUND AND AIMS Continuous infusion of terlipressin is better tolerated, and equally effective at lower doses than intravenous boluses in type 1 hepatorenal syndrome. This approach in cirrhosis patients with acute esophageal variceal bleed was investigated by comparing the efficacy and adverse events of continuous versus bolus administration of terlipressin. METHODS One hundred ten consecutive cirrhosis patients with acute esophageal variceal bleed (AEVB) were randomized to receive either terlipressin as bolus (BOL, n = 55), 2 mg every 4 h, or, continuous infusion (CONI, n = 55), 4 mg/24 h for 5 days. Hepatic venous pressure gradient (HVPG) was measured at baseline, 12 and 24 h and response to terlipressin was defined as > 10% decline from baseline. RESULTS Baseline demographics, model for end-stage liver disease (MELD) and HVPG were comparable between groups. The primary objective of HVPG response at 24 h was achieved in significantly more patients in CONI than BOL group {47/55(85.4%) vs. 32/55(58.2%), p = 0.002}. Early HVPG response at 12 h was also higher in CONI group (71.5 vs. 49.1%, p < 0.01). Median dose of terlipressin was significantly lower {4.25 ± 1.26 mg vs. 7.42 ± 1.42 mg/24 h, p < 0.001)} and adverse events were fewer {20/55(36.3%) vs. 31/55(56.4%), p = 0.03} in the CONI than BOL group. Significantly higher incidence of very early rebleed was noted in BOL group {8/55 (14.5%) vs. 1/55, (1.8%), p = 0.03}. Baseline HVPG (OR 1.90, 95% CI = 1.25-2.89, p = 0.002) and MELD (OR 1.18, 95% CI = 0.99-1.41, p = 0.05) were predictors of rebleed. CONCLUSION "HVPG-tailored" continuous terlipressin infusion is more effective than bolus administration in reducing HVPG at a lower dose with fewer adverse events in cirrhotic patients. CLINICAL TRIAL IDENTIFIER NCT02695862.
PICO Summary
Population
Patients with cirrhosis and acute esophageal variceal bleed (n= 110).
Intervention
Intravenous bolus injections of terlipressin (BOL group), (n= 55).
Comparison
Low-dose of continuous terlipressin infusion (CONI group), (n= 55).
Outcome
The primary objective of hepatic venous pressure gradient (HVPG) response at 24 hours was achieved in significantly more patients in CONI than BOL group (47/55 (85.4%) vs. 32/55 (58.2%)). Early HVPG response at 12 hours was also higher in CONI group (71.5 vs. 49.1%). Median dose of terlipressin was significantly lower (4.25 ± 1.26 mg vs. 7.42 ± 1.42 mg/24 h) and adverse events were fewer (20/55 (36.3%) vs. 31/55 (56.4%)) in the CONI than BOL group. Significantly higher incidence of very early rebleed was noted in BOL group (8/55 (14.5%) vs. 1/55, (1.8%)). Baseline HVPG (OR 1.90, 95% CI 1.25 to 2.89) and model for end-stage liver disease (OR 1.18, 95% CI 0.99 to 1.41) were predictors of rebleed.
-
6.
Standard-Volume Plasma Exchange Improves Outcomes in Patients With Acute Liver Failure: A Randomized Controlled Trial
Maiwall R, Bajpai M, Singh A, Agarwal T, Kumar G, Bharadwaj A, Nautiyal N, Tevethia H, Jagdish RK, Vijayaraghavan R, et al
Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association. 2022;20(4):e831-e854
-
-
-
-
Editor's Choice
Abstract
BACKGROUND High volume plasma-exchange (HVPE) improves survival in patients with acute liver failure (ALF), but apprehension regarding volume overload and worsening of cerebral edema remain. METHODS In an open-label randomized controlled trial, 40 consecutive patients of ALF were randomized 1:1 to either standard medical treatment (SMT) or SMT with standard-volume plasma-exchange (SVPE). SVPE was performed using centrifugal apheresis [target volume of 1.5 to 2.0 plasma volumes per session] until desired response was achieved. Cerebral edema was assessed by brain imaging. Results were analyzed in an intention-to-treat analysis. Primary outcome was 21-day transplant-free survival. The levels of cytokines, damage-associated molecular patterns (DAMPs) and endotoxins were analyzed at baseline and day 5. RESULTS ALF patients [aged 31.5 ± 12.2 years, 60% male, 78% viral, 83% hyperacute, 70% with SIRS were included. At day 5, SVPE [mean sessions 2.15 ± 1.42, median plasma volume replaced 5.049 L] compared to SMT alone, resulted in higher lactate clearance (p = .02), amelioration of SIRS (84% vs. 26%; P = .02), reduction in ammonia levels [(221.5 ± 96.9) vs.(439 ± 385.6) μg/dl, P = .02) and SOFA scores [9.9(±3.3) vs. 14.6(±4.8); P = .001]. There were no treatment related deaths. SVPE was associated with a higher 21-day transplant free-survival [75% vs. 45%; P = .04, HR 0.30, 95%CI 0.01-0.88]. A significant decrease in levels of pro-inflammatory cytokines and an increase in anti-inflammatory cytokines along with a decrease in endotoxin and DAMPs was seen with SVPE. CONCLUSION In ALF patients with cerebral edema, SVPE is safe and effective and improves survival possibly by a reduction in cytokine storm and ammonia. CLINICALTRIAL gov (identifier: NCT02718079).
PICO Summary
Population
Patients with acute liver failure (n= 40).
Intervention
Standard medical treatment with standard volume plasma exchange (SVPE), (n= 20).
Comparison
Standard medical treatment (n= 20).
Outcome
Compared to standard medical treatment alone, at day five SVPE resulted in higher lactate clearance, amelioration of systemic inflammatory response syndrome (84% vs. 26%), reduction in ammonia levels [(221.5 ± 96.9) vs. (439 ± 385.6) μg/dl] and sequential organ failure assessment scores [9.9(±3.3) vs. 14.6(±4.8)]. There were no treatment related deaths. SVPE was associated with a higher 21-day transplant free-survival (75% vs. 45%). A significant decrease in levels of pro-inflammatory cytokines and an increase in anti-inflammatory cytokines along with a decrease in endotoxin and damage-associated molecular patterns was seen with SVPE.
-
7.
A Randomized Trial of Albumin Infusions in Hospitalized Patients with Cirrhosis
China L, Freemantle N, Forrest E, Kallis Y, Ryder SD, Wright G, Portal AJ, Becares Salles N, Gilroy DW, O'Brien A
The New England journal of medicine. 2021;384(9):808-817
-
-
-
-
Editor's Choice
Abstract
BACKGROUND Infection and increased systemic inflammation cause organ dysfunction and death in patients with decompensated cirrhosis. Preclinical studies provide support for an antiinflammatory role of albumin, but confirmatory large-scale clinical trials are lacking. Whether targeting a serum albumin level of 30 g per liter or greater in these patients with repeated daily infusions of 20% human albumin solution, as compared with standard care, would reduce the incidences of infection, kidney dysfunction, and death is unknown. METHODS We conducted a randomized, multicenter, open-label, parallel-group trial involving hospitalized patients with decompensated cirrhosis who had a serum albumin level of less than 30 g per liter at enrollment. Patients were randomly assigned to receive either targeted 20% human albumin solution for up to 14 days or until discharge, whichever came first, or standard care. Treatment commenced within 3 days after admission. The composite primary end point was new infection, kidney dysfunction, or death between days 3 and 15 after the initiation of treatment. RESULTS A total of 777 patients underwent randomization, and alcohol was reported to be a cause of cirrhosis in most of these patients. A median total infusion of albumin of 200 g (interquartile range, 140 to 280) per patient was administered to the targeted albumin group (increasing the albumin level to ≥30 g per liter), as compared with a median of 20 g (interquartile range, 0 to 120) per patient administered to the standard-care group (adjusted mean difference, 143 g; 95% confidence interval [CI], 127 to 158.2). The percentage of patients with a primary end-point event did not differ significantly between the targeted albumin group (113 of 380 patients [29.7%]) and the standard-care group (120 of 397 patients [30.2%]) (adjusted odds ratio, 0.98; 95% CI, 0.71 to 1.33; P = 0.87). A time-to-event analysis in which data were censored at the time of discharge or at day 15 also showed no significant between-group difference (hazard ratio, 1.04; 95% CI, 0.81 to 1.35). More severe or life-threatening serious adverse events occurred in the albumin group than in the standard-care group. CONCLUSIONS In patients hospitalized with decompensated cirrhosis, albumin infusions to increase the albumin level to a target of 30 g per liter or more was not more beneficial than the current standard care in the United Kingdom. (Funded by the Health Innovation Challenge Fund; ATTIRE EudraCT number, 2014-002300-24; ISRCT number, N14174793.).
PICO Summary
Population
Hospitalized patients with cirrhosis enrolled in the ATTIRE trial (n= 777).
Intervention
Targeted 20% human albumin solution (n= 380).
Comparison
Standard care (n= 397).
Outcome
The composite primary end point was new infection, kidney dysfunction, or death between days 3 and 15 after the initiation of treatment. The percentage of patients with a primary end point event did not differ significantly between the targeted albumin group (113 of 380 patients [29.7%]) and the standard-care group (120 of 397 patients [30.2%]). A time-to-event analysis in which data were censored at the time of discharge or at day 15 also showed no significant between-group difference. More severe or life-threatening serious adverse events occurred in the albumin group than in the standard-care group.
-
8.
Albumin in the management of hepatic encephalopathy: a systematic review and meta-analysis
Is B, Bombassaro IZ, Tovo CV, de Mattos ÂZ, Ahlert M, Chiesa T, de Mattos AA
Annals of hepatology. 2021;:100541
-
-
-
Free full text
-
Editor's Choice
Abstract
INTRODUCTION AND OBJECTIVES It has been suggested that albumin administration could alter the natural history of cirrhosis, and also, that long-term treatment with albumin might be associated with improvement in survival, control of ascites, reduction in the incidence bacterial infections, renal dysfunction, hepatic encephalopathy (HE) and hyponatremia, as well as reduction in length of hospitalization in patients with cirrhosis and ascites. The objective of the present study is to evaluate the role of albumin in the management of HE. MATERIALS AND METHODS This is a systematic review of randomized controlled trials that evaluated the use of albumin in adult patients with cirrhosis and HE. The search for eligible studies was performed in MEDLINE, EMBASE, and Cochrane CENTRAL databases until June 2020. The outcomes of interest were the complete reversal of HE and mortality. Meta-analysis was performed using the random effects model, through the Mantel-Haenszel method. RESULTS This systematic review was registered at the PROSPERO platform (CRD42020194181). The search strategy retrieved 1,118 articles. After reviewing titles and abstracts, 24 studies were considered potentially eligible, but 22 were excluded after full-text analysis. Finally, 2 studies were included. In the meta-analysis, albumin was associated to significant lower risks of persistent HE (risk ratio - RR=0.60; 95% confidence interval - CI=0.38-0.95, p=0.03) and mortality (RR=0.54; 95% CI=0.33-0.90, p=0.02). CONCLUSION Albumin administration improves HE and reduces mortality in patients with cirrhosis and HE.
PICO Summary
Population
Patients with cirrhosis and hepatic encephalopathy (HE), (2 studies, n= 176).
Intervention
Albumin or lactulose plus albumin (n= 86).
Comparison
Saline solution or lactulose alone (n= 90).
Outcome
In the meta-analysis, albumin was associated to significant lower risks of persistent HE (risk ratio - RR=0.60) and mortality (RR=0.54).
-
9.
Plasma trial: Pilot randomized clinical trial to determine safety and efficacy of plasma transfusions
Carson JL, Ness PM, Pagano MB, Philipp CS, Bracey AWJr, Brooks MM, Nosher JL, Hogshire L, Noveck H, Triulzi DJ
Transfusion. 2021
-
-
-
-
Editor's Choice
Abstract
BACKGROUND Plasma is frequently administered to patients with prolonged INR prior to invasive procedures. However, there is limited evidence evaluating efficacy and safety. STUDY DESIGN AND METHODS We performed a pilot trial in hospitalized patients with INR between 1.5 and 2.5 undergoing procedures conducted outside the operating room. We excluded patients undergoing procedures proximal to the central nervous system, platelet counts <40,000/μl, or congenital or acquired coagulation disorders unresponsive to plasma. We randomly allocated patients stratified by hospital and history of cirrhosis to receive plasma transfusion (10-15 cc/kg) or no transfusion. The primary outcome was change in hemoglobin concentration within 2 days of procedure. RESULTS We enrolled 57 patients, mean age 56.0, 34 (59.6%) with cirrhosis, and mean INR 1.92 (SD = 0.27). In the intention to treat analysis, there were 10 of 27 (38.5%) participants in the plasma arm with a post procedure INR <1.5 and one of 30 (3.6%) in the no treatment arm (p < .01). The mean INR after receiving plasma transfusion was -0.24 (SD 0.26) lower than baseline. The change from pre-procedure hemoglobin level to lowest level within 2 days was -0.6 (SD = 1.0) in the plasma transfusion arm and -0.4 (SD = 0.6) in the no transfusion arm (p = .29). Adverse outcomes were uncommon. DISCUSSION We found no differences in change in hemoglobin concentration in those treated with plasma compared to no treatment. The change in INR was small and corrected to less than 1.5 in minority of patients. Large trials are required to establish if plasma is safe and efficacious.
PICO Summary
Population
Patients with cirrhosis (n= 57).
Intervention
Plasma transfusion (n= 27).
Comparison
No transfusion (n= 30).
Outcome
In the intention to treat analysis, there were 10 of 27 (38.5%) participants in the plasma arm with a post procedure INR <1.5 and one of 30 (3.6%) in the no treatment arm. The mean INR after receiving plasma transfusion was -0.24 (SD 0.26) lower than baseline. The change from pre-procedure haemoglobin level to lowest level within 2 days was -0.6 (SD = 1.0) in the plasma transfusion arm and -0.4 (SD = 0.6) in the no transfusion arm. Adverse outcomes were uncommon.