Neutralizing COVID-19 Convalescent Plasma in Adults Hospitalized with COVID-19: A Blinded Randomized Placebo-Controlled Trial
BACKGROUND Convalescent plasma has been one of the most common treatments for COVID-19, but most clinical trial data to date have not supported its efficacy. RESEARCH QUESTION Is rigorously selected COVID-19 convalescent plasma with neutralizing anti-SARS-CoV-2 antibodies an efficacious treatment for adults hospitalized with COVID-19? STUDY DESIGN AND METHODS This was a multicenter, blinded, placebo-controlled randomized clinical trial among adults hospitalized with SARS-CoV-2 infection and acute respiratory symptoms for <14 days. Enrolled patients were randomly assigned to receive one unit of COVID-19 convalescent plasma (n=487) or placebo (n=473). The primary outcome was clinical status (illness severity) 14 days after study infusion measured with a seven-category ordinal scale ranging from discharged from the hospital with resumption of normal activities (lowest score) to death (highest score). The primary outcome was analyzed with a multivariable ordinal regression model, with an adjusted odds ratio (aOR) <1.0 indicating more favorable outcomes with convalescent plasma than placebo. In secondary analyses, trial participants were stratified by the presence of endogenous anti-SARS-CoV-2 antibodies ("serostatus") at randomization. The trial included 13 secondary efficacy outcomes, including 28-day mortality. RESULTS Among 974 randomized patients, 960 were included in the primary analysis. Clinical status on the ordinal outcome scale at 14 days did not differ between the convalescent plasma and placebo groups in the overall population (aOR: 1.04; 1/7 support interval (SI): 0.82-1.33), in patients without endogenous antibodies (aOR: 1.15; 1/7 SI: 0.74-1.80), or in patients with endogenous antibodies (aOR: 0.96; 1/7 SI: 0.72-1.30). None of the 13 secondary efficacy outcomes were different between groups. At 28 days, 89/482 (18.5%) patients in the convalescent plasma group and 80/465 (17.2%) patients in the placebo group had died (aOR: 1.04, 1/7 SI: 0.69-1.58). INTERPRETATION Among adults hospitalized with COVID-19, including those seronegative for anti-SARS-CoV-2 antibodies, treatment with convalescent plasma did not improve clinical outcomes.
Balanced crystalloid vs saline in adults with traumatic brain injury: secondary analysis of a clinical trial
Journal of neurotrauma. 2022
Balanced crystalloids may improve outcomes compared to saline for some critically ill adults. Lower tonicity of balanced crystalloids could worsen cerebral edema in patients with intracranial pathology. The effect of balanced crystalloids versus saline on clinical outcomes in patients with traumatic brain injury (TBI) requires further study. We planned an a priori subgroup analysis of TBI patients enrolled in the pragmatic, cluster-randomized, multiple-crossover Isotonic Solutions and Major Adverse Renal Events Trial (SMART) (ClinicalTrials.gov: NCT02444988, NCT02547779). Primary outcome was 30-day in-hospital mortality. Secondary outcomes included hospital discharge disposition (home, facility, death). Regression models adjusted for pre-specified baseline covariates compared outcomes. TBI patients assigned to balanced crystalloids (n=588) and saline (n=569) had similar baseline characteristics including Injury Severity Score 19 (10); mean maximum head/neck Abbreviated Injury Score, 3.4 (1.0). Isotonic crystalloid volume administered between ICU admission and first of hospital discharge or 30 days was 2037 (3470) mL and 1723 (2923) mL in the balanced crystalloids and saline groups, respectively (P=0.18). During the study period, 94 (16%) and 82 (14%) patients (16%) died in the balanced crystalloid and saline groups, respectively (aOR, 1.03; 95% confidence interval [CI], 0.60 to 1.75; P=0.913). Patients in the balanced crystalloid group were more likely to die or be discharged to another medical facility (aOR 1.38 [1.02-1.86]; P=0.04). Overall, balanced crystalloids were associated with worse discharge disposition in critically injured patients with TBI compared to saline. The confidence intervals cannot exclude a clinically relevant increase in mortality when balanced crystalloids are used for patients with TBI.
Flapless osteotome-mediated sinus floor elevation using platelet-rich fibrin versus lateral approach using deproteinised bovine bone mineral for residual bone height of 2-6 mm: a randomised trial
Clinical oral implants research. 2022
OBJECTIVES To evaluate patient-reported outcomes and radiographic results of simultaneous implant placement in severely atrophic maxilla using flapless endoscope-assisted osteotome sinus floor elevation with platelet-rich fibrin (PRF), also defined as PESS, and to compare the results with those of lateral sinus floor elevation (LSFE). METHODS Patients with a residual bone height (RBH) of 2-6 mm were included in a randomised controlled trial. PESS was performed with PRF as the sole grafting material. LSFE was performed using deproteinised bovine bone matrix. Patient-reported outcomes were recorded on a visual analogue scale (VAS-pain) and visual rating scale (VRS-swelling and VRS-willingness). Peri-implant bone height (PBH), bone mineral density (BMD), and sinus grafting remodelling index were measured using CBCT immediately postoperatively and 3(rd) , 6(th) and 18(th) months post-surgery. RESULTS The study population consisted of 20 patients in each group. The RBH of two groups averaged 3.35±0.79 mm and 2.92±0.63 mm with no significant difference (p > 0.05). VAS-pain was 18.0 (IR 15.0-22.5) and 35.0 (IR 32.5-37.0) in the PESS and LSFE groups, respectively (p < 0.01). VAS-pain decreased with time in both groups. VRS-swelling was lower in the PESS group than LSFE group. VRS-willingness was higher in the PESS group than LSFE group (p < 0.01). At 18 months post-surgery, the marginal bone loss was 0.60±0.25 mm and 0.69±0.35 mm in the two groups with no significant difference (p = 0.52). CONCLUSIONS Within the limitations of this study, PESS was associated with lower postoperative morbidity and was more tolerable than LSFE. PESS could be a reliable procedure for sinus floor elevation in patients with insufficient RBH.
Clinical efficacy and safety of neuroendoscopic surgery for severe thalamic hemorrhage with ventricle encroachment
Neurosurgical review. 2022
To summarize and analyze the clinical efficacy and safety of neuroendoscopic surgery (NES) in the treatment of patients for severe thalamic hemorrhage with ventricle encroachment (THVE). Eighty-three patients with severe THVE were treated in the Neurosurgery Department of Anqing Hospital Affiliated to Anhui Medical University from July 2019 to August 2021. Our study was approved by the ethics committee. The patients were randomly divided into NES group and extraventricular drainage (EVD) group. The hospital stay, Glasgow coma scale (GCS) scores on the 1st and 14th days postoperatively, the incidence of intracranial infections, and the clearance of postoperative hematomas were compared and analyzed between the two groups. The patients had follow-up evaluations 6 months postoperatively. The prognosis was evaluated based on the activity of daily living (ADL) score. A head CT or MRI was obtained to determine whether there was hydrocephalus, cerebral infarction, or other related complications. Eighty-three patients were randomly divided into 41 cases of NES group and 42 cases of EVD group. The length of postoperative hospital stay was 17.42 ± 1.53 days, the GCS scores were 6.56 ± 0.21, and 10.83 ± 0.36 on days 1 and 14, respectively; intracranial infections occurred in 3 patients (7.31%) and the hematoma clearance rate was 83.6 ± 5.18% in the NES group, all of which were significantly better than the EVD group (P < 0.05). After 6 months of follow-up, 28 patients (68.29%) had a good prognosis, 5 patients (12.19%) died, and 4 patients (9.75%) had hydrocephalus in the NES group. In the EVD group, the prognosis was good in 15 patients (35.71%), 12 patients (28.57%) died, and 17 patients (40.47%) had hydrocephalus. The prognosis, mortality rate, and incidence of hydrocephalus in the NES group were significantly better than the EVD group (P < 0.05). Compared to traditional EVD, NES for severe THVE had a higher hematoma clearance rate, and fewer intracranial infections and patients with hydrocephalus, which together improve the clinical prognosis and is thus recommended for clinical use.
Intraoperative Cell Salvage for Women at High Risk of Postpartum Hemorrhage During Cesarean Section: a Systematic Review and Meta-analysis
Reproductive sciences (Thousand Oaks, Calif.). 2022
Postpartum hemorrhage (PPH) can lead to substantial blood loss that compromises maternal hemodynamic stability and consequently cause severe maternal complications such as organ dysfunction or death. Intraoperative cell salvage (IOCS), an effective method of blood conservation used in other surgical specialties, can be an alternative intervention for managing PPH. Thus, our aim was to evaluate the efficacy and safety of IOCS for women at high risk of PPH undergoing cesarean sections. We conducted a systematic search of electronic databases from inception to February 25, 2021 for randomized controlled studies and observational studies published in English or Mandarin about IOCS use in cesarean sections. Primary outcomes of interest were changes in postoperative hematologic parameters and any adverse events reported among patients that had IOCS and controls that had an allogeneic blood transfusion. The certainty of the evidence of the outcomes was evaluated using the GRADE approach. A total of 24 studies with 5872 patients were included in the meta-analysis. Eleven randomized controlled trials (RCTs), and 13 observational studies were analyzed. Postoperative hemoglobin levels were higher among patients with IOCS SMD 0.39 (95% CI; 0.20, 0.60; P < 0.001, high certainty). Allogeneic blood transfusion increased adverse events RR = 1.81(95% CI; 1.24, 2.62; P = 0.002, low certainty). IOCS shortened hospital stay SMD - 0.59 (95% CI: - 0.98, - 0.19; P = 0.004, low certainty) and shortened prothrombin time SMD - 0.67 (95% CI; - 1.31, - 0.04), P = 0.037, low certainty). The lower incidence of transfusion-related adverse events and shorter hospital stay among other findings demonstrate that IOCS use in obstetrics is an effective and safe alternative for the management of PPH; however, high-quality randomized control studies are required to confirm this evidence.
Effect of Tranexamic Acid on Blood Management during a High Tibial Osteotomy: A Systematic Review and Meta-analysis
Orthopaedic surgery. 2022
This study aimed to evaluate the efficiency and safety of tranexamic acid for blood management during high tibial osteotomy (HTO). A systematic search was conducted in Medline, Embase, and the Cochrane library database. Six studies and 208 patients were included in this meta-analysis using Review Manager V.5.3 and Stata 15.1 software. For primary outcomes, tranexamic acid lowered the total blood loss (WMD = -219.47, 95% CI [-355.61, -83.33], P = 0.002). For secondary outcomes, a significant reduction was found for decreased hemoglobin (POD1: WMD = -9.86, 95% CI [-13.45, -6.28], P < 0.05; POD2: WMD = -8.41, 95% CI [-11.50, -5.32], P < 0.05; POD5: WMD = -11.48, 95% CI [-14.56, -8.39], P < 0.05) and drainage (total: WMD = -105.93, 95% CI [-187.08, -24.78], P < 0.05; POD1: WMD = -122.195, 95% CI [-168.902, -75.488], P < 0.05). The sex difference (male/female ratio) was determined (total blood loss: P = 0.025; total drainage amount: p = 0.018) using meta-regression analysis. Females benefited more from tranexamic acid in terms of total blood loss (M/F > 40%: WMD = -53.11, 95% CI [-100.16, -6.05], P = 0.03; 40% ≥ M/F ≥ 20%: WMD = -362.20, 95% CI [-423.96, -300.45], P < 0.05; M/F < 20%: WMD = -263.00, 95% CI [-277.17, -248.83], P < 0.05) and total drainage (M/F > 40%: WMD = -7.11, 95% CI [-10.75, -3.47], P < 0.05; 40% ≥ M/F ≥ 20%: WMD = -104.72, 95% CI [-155.36, -54.08], P < 0.05; M/F < 20%: WMD = -222.00, 95% CI [-297.42, -146.58], P < 0.05). No significant differences were found for drainage on POD2 and POD3, wound complications, orthromboembolic events. In conclusion, tranexamic acid is effective and safe for blood management during HTO. Females appeared to benefit more from it, and an additional postoperative dose is suggested fora better effect.
The use of FEIBA for refractory bleeding in cardiac surgery - a systematic review
Expert review of cardiovascular therapy. 2022
INTRODUCTION Significant blood loss during cardiac surgery is associated with a significant increase in morbidity and mortality. Factor Eight Inhibitor Bypassing Activity (FEIBA), a hemostatic bypassing agent mainly used in hemophiliac patients, has also been used for intractable surgical bleeding during cardiac surgical procedures in non-hemophiliac patients. However, concerns exist that its use may be linked to increased incidence of perioperative adverse effects including thrombotic complications. AREAS COVERED A systematic literature search was performed on MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials databases for all studies that reported the administration of FEIBA for treatment of bleeding during adult cardiac surgery in non-hemophiliac patients. After selecting of title and abstracts, two authors assessed the methodological quality of the full-text articles prior to final inclusion in the manuscript. EXPERT OPINION The safety profile of FEIBA was determined through an aggregate count of adverse events. Major complications included renal failure, re-operation for unresolved bleeding, postoperative mortality, and thromboembolic events. Overall, there is insufficient robust evidence to make a definitive conclusion about the safety or efficacy of using of FEIBA as a hemostatic agent in the setting of cardiac surgery.
Clinical Outcomes of Negative Balloon-Assisted Enteroscopy for Obscure Gastrointestinal Bleeding: A Systematic Review and Meta-Analysis
Frontiers in medicine. 2022;9:772954
BACKGROUND For patients with obscure gastrointestinal bleeding (OGIB), finding the bleeding site is challenging. Balloon-assisted enteroscopy (BAE) has become the preferred diagnostic modality for OGIB. The long-term outcome of patients with negative BAE remains undefined. The present study aimed to evaluate the long-term outcomes of patients with negative BAE results for OGIB and to clarify the effect of further investigations at the time of rebleeding with a systematic review and meta-analysis of the available cohort studies. METHODS Studies were searched through the PubMed, EMBASE, and Cochrane library databases. The following indexes were analyzed: rebleeding rate after negative BAE, rebleeding rate after different follow-up periods, the proportion of patients who underwent further evaluation after rebleeding, the percentage of patients with identified rebleeding sources, and the percentage of patients with rebleeding sources in the small intestine. Heterogeneity was assessed using the I(2) test. RESULTS Twelve studies that involved a total of 407 patients were included in the analysis. The pooled rebleeding rate after negative BAE for OGIB was 29.1% (95% CI: 17.2-42.6%). Heterogeneity was significant among the studies (I(2) = 88%; p < 0.0001). The Chi-squared test did not show a difference in rebleeding rates between the short and long follow-up period groups (p = 0.142). The pooled proportion of patients who underwent further evaluation after rebleeding was 86.1%. Among the patients who underwent further evaluation, rebleeding sources were identified in 73.6% of patients, and 68.8% of the identified rebleeding lesions were in the small intestine. CONCLUSION A negative result of BAE in patients with OGIB indicates a subsequently low risk of rebleeding. Further evaluation should be considered after rebleeding.
Clinical efficacy of comprehensive nursing in patients with cerebral hemorrhagic hemiplegia
American journal of translational research. 2021;13(5):5526-5532
OBJECTIVE To explore the clinical efficacy of comprehensive rehabilitation nursing (CRN) intervention in patients with cerebral hemorrhagic hemiplegia (CHH). METHODS A total of 102 patients with CHH admitted to our hospital were selected for the prospective study. The patients were randomly divided into the control group (n=51) and the observation group (n=51) according to the random number table method. Routine nursing was performed in the control group, while CRN was conducted in the observation group. Fugl-Meyer motor function assessment scale, activity of daily living scale (Barthel index), self-rating anxiety scale (SAS), complications and muscle strength improvement (Brunnstrom assessment) were compared between the two groups. RESULTS Compared with those before nursing, Fugl-Meyer score, Barthel index and SAS score in the two groups after nursing were significantly improved (P<0.01). Fugl-Meyer score and Barthel index of the observation group were significantly higher than those of the control group after nursing, while SAS score showed the opposite change (P<0.001). The incidence of complications in the control group was 49.02%, and that in the observation group was 29.41% (P<0.05). The rate of muscle strength improvement in the observation group was 80.39% after nursing, which was significantly higher than that in the control group (60.78%; P<0.05). CONCLUSION CRN intervention has a positive clinical efficacy in patients with CHH. It can enhance motor ability, improve the ability of daily life, amend psychological mood and reduce the incidence of complications.
Clinical Features in Children With Kawasaki Disease Shock Syndrome: A Systematic Review and Meta-Analysis
Frontiers in cardiovascular medicine. 2021;8:736352
Objective: This study aimed to identify the clinical features of Kawasaki disease shock syndrome (KDSS) in children. Methods: The case-control studies of KDSS and KD children up until April 30, 2021 were searched in multiple databases. The qualified research were retrieved by manually reviewing the references. Review Manager 5.3 software was used for statistical analysis. Results: The results showed that there was no significant difference in the incidence of male and female in children with KDSS. Children with KDSS compared with non-shocked KD, there were significant difference in age, duration of fever, white blood cell (WBC) count, percentage of neutrophils (NEUT%), platelet count (PLT), c-reactive protein level (CRP), alanine transaminase concentration (ALT), aspartate transaminase concentration (AST), albumin concentration (ALB), sodium concentration (Na), ejection fraction, and length of hospitalization as well as the incidence of coronary artery dilation, coronary artery aneurysm, left ventricular dysfunction, mitral regurgitation, pericardial effusion, initial diagnosis of KD, intravenous immunoglobulin (IVIG) resistance and receiving second dose of IVIG, vasoactive drugs, hormones, and albumin. In contrast, there was no difference in the hemoglobin concentration, erythrocyte sedimentation rate, and the incidence of conjunctival injection, oropharyngeal change, polymorphous rash, extremity change, and incomplete KD. Conclusion: Current evidence suggested that the children with KDSS had more severe indicators of inflammation and more cardiac abnormalities. These patients were resistant to immunoglobulin treatment and required extra anti-inflammatory treatment. Systematic Review Registration: PROSPERO registration number CRD42021241207.