1.
Association of Convalescent Plasma Treatment With Clinical Status in Patients Hospitalized With COVID-19: A Meta-analysis
Troxel AB, Petkova E, Goldfeld K, Liu M, Tarpey T, Wu Y, Wu D, Agarwal A, Avendaño-Solá C, Bainbridge E, et al
JAMA network open. 2022;5(1):e2147331
Abstract
IMPORTANCE COVID-19 convalescent plasma (CCP) is a potentially beneficial treatment for COVID-19 that requires rigorous testing. OBJECTIVE To compile individual patient data from randomized clinical trials of CCP and to monitor the data until completion or until accumulated evidence enables reliable conclusions regarding the clinical outcomes associated with CCP. DATA SOURCES From May to August 2020, a systematic search was performed for trials of CCP in the literature, clinical trial registry sites, and medRxiv. Domain experts at local, national, and international organizations were consulted regularly. STUDY SELECTION Eligible trials enrolled hospitalized patients with confirmed COVID-19, not receiving mechanical ventilation, and randomized them to CCP or control. The administered CCP was required to have measurable antibodies assessed locally. DATA EXTRACTION AND SYNTHESIS A minimal data set was submitted regularly via a secure portal, analyzed using a prespecified bayesian statistical plan, and reviewed frequently by a collective data and safety monitoring board. MAIN OUTCOMES AND MEASURES Prespecified coprimary end points-the World Health Organization (WHO) 11-point ordinal scale analyzed using a proportional odds model and a binary indicator of WHO score of 7 or higher capturing the most severe outcomes including mechanical ventilation through death and analyzed using a logistic model-were assessed clinically at 14 days after randomization. RESULTS Eight international trials collectively enrolled 2369 participants (1138 randomized to control and 1231 randomized to CCP). A total of 2341 participants (median [IQR] age, 60 [50-72] years; 845 women [35.7%]) had primary outcome data as of April 2021. The median (IQR) of the ordinal WHO scale was 3 (3-6); the cumulative OR was 0.94 (95% credible interval [CrI], 0.74-1.19; posterior probability of OR <1 of 71%). A total of 352 patients (15%) had WHO score greater than or equal to 7; the OR was 0.94 (95% CrI, 0.69-1.30; posterior probability of OR <1 of 65%). Adjusted for baseline covariates, the ORs for mortality were 0.88 at day 14 (95% CrI, 0.61-1.26; posterior probability of OR <1 of 77%) and 0.85 at day 28 (95% CrI, 0.62-1.18; posterior probability of OR <1 of 84%). Heterogeneity of treatment effect sizes was observed across an array of baseline characteristics. CONCLUSIONS AND RELEVANCE This meta-analysis found no association of CCP with better clinical outcomes for the typical patient. These findings suggest that real-time individual patient data pooling and meta-analysis during a pandemic are feasible, offering a model for future research and providing a rich data resource.
2.
Restricted fluid resuscitation in suspected sepsis associated hypotension (REFRESH): a pilot randomised controlled trial
Macdonald SPJ, Keijzers G, Taylor DM, Kinnear F, Arendts G, Fatovich DM, Bellomo R, McCutcheon D, Fraser JF, Ascencio-Lane JC, et al
Intensive Care Medicine. 2018;44((12):):2070-2078.
Abstract
PURPOSE To determine if a regimen of restricted fluids and early vasopressor compared to usual care is feasible for initial resuscitation of hypotension due to suspected sepsis. METHODS A prospective, randomised, open-label, clinical trial of a restricted fluid resuscitation regimen in the first 6 h among patients in the emergency department (ED) with suspected sepsis and a systolic blood pressure under 100 mmHg, after minimum 1000 ml of IV fluid. Primary outcome was total fluid administered within 6 h post randomisation. RESULTS There were 99 participants (50 restricted volume and 49 usual care) in the intention-to-treat analysis. Median volume from presentation to 6 h in the restricted volume group was 2387 ml [first to third quartile (Q1-Q3) 1750-2750 ml]; 30 ml/kg (Q1-Q3 32-39 ml/kg) vs. 3000 ml (Q1-Q3 2250-3900 ml); 43 ml/kg (Q1-Q3 35-50 ml/kg) in the usual care group (p < 0.001). Median duration of vasopressor support was 21 h (Q1-Q3 9-42 h) vs. 33 h (Q1-Q3 15-50 h), (p = 0.13) in the restricted volume and usual care groups, respectively. At 90-days, 4 of 48 (8%) in the restricted volume group and 3 of 47 (6%) in the usual care group had died. Protocol deviations occurred in 6/50 (12%) in restricted group and 11/49 (22%) in the usual care group, and serious adverse events in four cases (8%) in each group. CONCLUSIONS A regimen of restricted fluids and early vasopressor in ED patients with suspected sepsis and hypotension appears feasible. Illness severity was moderate and mortality rates low. A future trial is necessary with recruitment of high-risk patients to determine effects on clinical outcomes in this setting.
3.
Does a single loading dose of tranexamic acid reduce perioperative blood loss and transfusion requirements after total knee replacement surgery? A randomized, controlled trial
Kundu R, Das A, Basunia SR, Bhattacharyya T, Chattopadhyay S, Mukherjee A
Journal of Natural Science Biology & Medicine. 2015;6((1):):94-9.
Abstract
BACKGROUND Total knee replacement (TKR) is associated with high-perioperative blood loss, which often requires allogenic blood transfusion. Among the many strategies to decrease the need for allogenic transfusion, tranexamic acid (TA) is used systemically in perioperative setting with promising outcome. Here we evaluated the efficacy of single preoperative bolus dose of TA on reduction in blood loss and red blood cell transfusion in patients undergoing unilateral TKR. MATERIALS AND METHODS 70, American Society of Anesthesiologists I-II patients scheduled for unilateral TKR were included. Patients were randomly allocated into two groups to receive either TA (Group-TA; 20 mg/kg diluted to 25 cc with normal saline) or an equivalent volume of normal saline (Group P). Hemoglobin concentration, packed cell volume, platelet count, fibrinogen level, D-dimer level was measured preoperatively and at 6(th) and 24(th) h postoperative period. RESULTS In Group P more blood, colloid and crystalloid solutions were used to replace the blood loss. 27 patients in Group TA did not require transfusion of any blood products compared to 6 patients in Group P (P < 0.0001) and only 3 units of blood was transfused in Group TA where as a total of 32 units of blood was transfused in Group P. Despite the more numerous transfusions, Hb% after 6 h and 24 h in Group P were considerably low in comparison with Group TA (P < 0.0001). CONCLUSION Tranexamic acid while significantly reducing blood loss caused by TKR surgery collaterally reduced the need for postoperative blood transfusion.
4.
Does the preoperative administration of tranexamic acid reduce perioperative blood loss and transfusion requirements after head neck cancer surgery? A randomized, controlled trial
Das A, Chattopadhyay S, Mandal D, Chhaule S, Mitra T, Mukherjee A, Mandal SK, Chattopadhyay S
Albang Maqalat Wa Abhat Fi Altahdir Waalinas. 2015;9((3)):384-90.
Abstract
BACKGROUND Head and neck cancer (HNC) surgery is associated with high intraoperative blood loss which may require urgent blood transfusion. Many strategies have been recommended to decrease the need for allogenic transfusion. Use of perioperative tranexamic acid (TA) has a promising role. AIMS This study was to evaluate the effectiveness of single preoperative bolus dose of TA on blood loss prevention and red blood cell transfusion in patients undergoing HNC surgery. STUDY DESIGN A prospective, double-blind, and randomized controlled study. MATERIALS AND METHODS From 2007 July to 2010 January; 80 patients, aged (35-55), of American Society of Anesthesiologists II-III scheduled for unilateral HNC surgeries were randomly received either TA (Group T) in a dose of 20 mg/kg diluted to 25 cc with normal saline or an equivalent volume of normal saline (Group C) in a tertiary care hospital. Hemoglobin (Hb) concentration, platelet count, packed cell volume, fibrinogen level, D-dimer level were measured pre- and post-operatively. RESULTS Saline (C) Group required more blood, colloid, crystalloid for blood loss. In Group T, 32 patients did not require transfusion of any blood products compared to five patients in Group C (P < 0.0001) and only eight units of blood was transfused in Group T, whereas a total of 42 units of blood was transfused in Group C. Even after numerous transfusions, Hb% after 6 h and 24 h in Group C were significantly low in comparison with Group T (P < 0.05). CONCLUSION Thus, TA significantly reduces blood loss and chances of colloid, blood, and crystalloid transfusion caused by HNC surgery.