1.
Comparison of a polysaccharide hemostatic powder and conventional therapy for peptic ulcer bleeding
Jung DH, Park CH, Choi SI, Kim HR, Lee M, Moon HS, Park JC
Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association. 2023
Abstract
BACKGROUND AND AIMS Hemostatic powders have been clinically used in the treatment of gastrointestinal bleeding. We investigated the non-inferiority of a polysaccharide hemostatic powder (PHP), compared with conventional endoscopic treatments, for peptic ulcer bleeding (PUB). METHODS This study was a prospective multicenter randomized open-label controlled trial at four referral institutions. We consecutively enrolled patients who had undergone emergency endoscopy for PUB. The patients were randomly assigned to either a PHP or conventional treatment group. In the PHP group, diluted epinephrine was injected, and the powder was applied as a spray. Conventional endoscopic treatment included the use of electrical coagulation or hemoclipping after injection of diluted epinephrine. RESULTS Between July 2017 and May 2021, 216 patients were enrolled in this study (PHP group, 105; control group, 111). Initial hemostasis was achieved in 92 of 105 patients (87.6%) in the PHP group and 96 of 111 patients (86.5%) in the conventional treatment group. Re-bleeding did not differ between the two groups. In subgroup analysis, the initial hemostasis failure rate in the conventional treatment group was 13.6% for Forrest IIa cases; however, there was no initial hemostasis failure in the PHP group (P=0.023). Large ulcer size (≥15mm) and chronic kidney disease with dialysis were independent risk factors for re-bleeding at 30 days. No adverse events were associated with PHP use. CONCLUSION PHP is not inferior to conventional treatments and could be of use in initial endoscopic treatment for PUB. Further studies are needed to confirm the re-bleeding rate of PHP (ClinicalTrials.gov 02717416).
2.
Liberal versus restrictive transfusion strategy in critically ill oncologic patients: the Transfusion Requirements in Critically Ill Oncologic Patients randomized controlled trial
Bergamin FS, Almeida JP, Landoni G, Galas FR, Fukushima JT, Fominskiy E, Park CH, Osawa EA, Diz MP, Oliveira GQ, et al
Critical Care Medicine. 2017;45((5):):766-773
Abstract
OBJECTIVE To assess whether a restrictive strategy of RBC transfusion reduces 28-day mortality when compared with a liberal strategy in cancer patients with septic shock. DESIGN Single center, randomized, double-blind controlled trial. SETTING Teaching hospital. PATIENTS Adult cancer patients with septic shock in the first 6 hours of ICU admission. INTERVENTIONS Patients were randomized to the liberal (hemoglobin threshold, < 9g/dL) or to the restrictive strategy (hemoglobin threshold, < 7g/dL) of RBC transfusion during ICU stay. MEASUREMENTS AND MAIN RESULTS Patients were randomized to the liberal (n = 149) or to the restrictive transfusion strategy (n = 151) group. Patients in the liberal group received more RBC units than patients in the restrictive group (1 [0-3] vs 0 [0-2] unit; p < 0.001). At 28 days after randomization, mortality rate in the liberal group (primary endpoint of the study) was 45% (67 patients) versus 56% (84 patients) in the restrictive group (hazard ratio, 0.74; 95% CI, 0.53-1.04; p = 0.08) with no differences in ICU and hospital length of stay. At 90 days after randomization, mortality rate in the liberal group was lower (59% vs 70%) than in the restrictive group (hazard ratio, 0.72; 95% CI, 0.53-0.97; p = 0.03). CONCLUSIONS We observed a survival trend favoring a liberal transfusion strategy in patients with septic shock when compared with the restrictive strategy. These results went in the opposite direction of the a priori hypothesis and of other trials in the field and need to be confirmed.