1.
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
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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.
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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
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Full text
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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.
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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
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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.