Project description:BackgroundAppropriate blood component transfusion might differ between intraoperative massive bleeding and traumatic massive bleeding in the emergency department because trauma patients initially bleed undiluted blood and replacement typically lags behind blood loss. We compared these two blood loss scenarios, intraoperative and traumatic, using a computer simulation.MethodsWe modified the multi-compartment dynamic model developed by Hirshberg and implemented it using STELLA 9.0. In this model, blood pressure changes as blood volume fluctuates as bleeding rate and transcapillary refill rate are controlled by blood pressure. Using this simulation, we compared the intraoperative bleeding scenario with the traumatic bleeding scenario. In both scenarios, patients started to bleed at a rate of 50 ml/min. In the intraoperative bleeding scenario, fluid was administered to maintain isovolemic status; however, in the traumatic bleeding scenario, no fluid was supplied for up to 30 min and no blood was supplied for up to 50 min. Each unit of packed red blood cells (PRBC) was given when the hematocrit decreased to 27%, fresh frozen plasma (FFP) was transfused when plasma was diluted to 30%, and platelet concentrate (PC) was transfused when platelet count became 50,000/ml.ResultsIn both scenarios, the appropriate ratio of PRBC:FFP was 1:0.47 before PC transfusion, and the ratio of PRBC:FFP:platelets was 1:0.35:0.39 after initiation of PC transfusion.ConclusionThe ratio of transfused blood component did not differ between the intraoperative bleeding and traumatic bleeding scenarios.
Project description:This study aimed to test the safety and efficacy of Hemospray® for emergency control of acute variceal bleeding (AVB) due to portal hypertension in cirrhotic patients.This single-arm, prospective trial, conducted at two hospitals in Belgium and Egypt, included patients admitted to the emergency room with hematemesis and/or melena and known or suspected liver cirrhosis. All patients received urgent hemodynamic stabilization, octreotide (50 mcg bolus then 25?mcg/hour for 24 hours) and intravenous ceftriaxone (1?g/hour). Endoscopy to confirm AVB and Hemospray® application (if indicated) was performed within six hours of admission. Patients were kept under observation for 24 hours and underwent second endoscopy and definitive therapy (band ligation and/or cyanoacrylate injection in cases of gastric varices) the next day.Thirty-eight patients were admitted for suspected AVB, and 30 of these had confirmed AVB (70% male; mean age 59.5 years (range, 32.0-73 years)). Child-Pugh class C liver disease was present in 53.4%. Esophageal varices were observed in 83.4% of patients, gastric varices in 10%, and duodenal varices in 6.6%. Spurting bleeding at the time of endoscopy was observed in 43.4%. One patient developed hematemesis six hours after Hemospray® application and underwent emergency endoscopic band ligation. No major adverse events or mortalities were observed during 15-day follow-up.Hemospray® application was safe and effective at short-term follow-up for emergency treatment of AVB in cirrhotic patients.
Project description:This postmarket clinical study evaluated the safety and effectiveness of the novel adjunctive topical hemostat SURGICEL® Powder (SURGICEL®-P), a powdered form of oxidized regenerated cellulose. In a prospective, open-label, single-arm multicenter trial, adult surgical subjects with mild-to-moderate bleeding for which conventional hemostatic methods were impractical/ineffective were treated with SURGICEL®-P. Descriptive analyses included hemostatic success rate at 3, 5, and 10 min, rebleeding and thromboembolic events, SURGICEL®-P-related serious adverse events requiring surgical intervention, and SURGICEL®-P ease of use (questionnaire). In 8 centers, 103 subjects were enrolled with a median (range) age of 64.0 (33.0-88.0) years. Surgeries were open (53.4%) or laparoscopic/thoracoscopic (46.6%) and mostly urological (37.9%) and abdominal (32.0%) procedures. Bleeding sites included various tissue types, with a median (range) surface area of 4 (0.02-72.0) cm2. Hemostatic success rates were 77.7%, 87.4%, and 92.2% at 3, 5, and 10 min, respectively. In 7 subjects (6.8%), investigators reverted to standard of care. No safety signals were identified. Two deaths occurred with causes unrelated to SURGICEL®-P. Investigators favorably evaluated the ease of use of the SURGICEL®-P device. SURGICEL®-P is safe and effective in controlling mild-to-moderate bleeding in a broad range of surgical procedures. The trial was registered at https://clinicaltrials.gov as NCT03762200.