Convalescent plasma in the treatment of moderate to severe COVID-19 pneumonia: a randomized controlled trial (PROTECT-Patient Trial)
Scientific reports. 2022;12(1):2552
There is a need for effective therapy for COVID-19 pneumonia. Convalescent plasma has antiviral activity and early observational studies suggested benefit in reducing COVID-19 severity. We investigated the safety and efficacy of convalescent plasma in hospitalized patients with COVID-19 in a population with a high HIV prevalence and where few therapeutic options were available. We performed a double-blinded, multicenter, randomized controlled trial in one private and three public sector hospitals in South Africa. Adult participants with COVID-19 pneumonia requiring non-invasive oxygen were randomized 1:1 to receive a single transfusion of 200 mL of either convalescent plasma or 0.9% saline solution. The primary outcome measure was hospital discharge and/or improvement of ≥ 2 points on the World Health Organisation Blueprint Ordinal Scale for Clinical Improvement by day 28 of enrolment. The trial was stopped early for futility by the Data and Safety Monitoring Board. 103 participants, including 21 HIV positive individuals, were randomized at the time of premature trial termination: 52 in the convalescent plasma and 51 in the placebo group. The primary outcome occurred in 31 participants in the convalescent plasma group and and 32 participants in the placebo group (relative risk 1.03 (95% CI 0.77 to 1.38). Two grade 1 transfusion-related adverse events occurred. Participants who improved clinically received convalescent plasma with a higher median anti-SARS-CoV-2 neutralizing antibody titre compared with those who did not (298 versus 205 AU/mL). Our study contributes additional evidence for recommendations against the use of convalescent plasma for COVID-19 pneumonia. Safety and feasibility in this population supports future investigation for other indications.
Tranexamic acid and reduction of blood transfusion in lower limb trauma surgery: a randomized controlled study
INTRODUCTION Post-operative blood loss in lower limb trauma fractures increases morbidity. Very few studies have evaluated the efficacy of Tranexamic Acid (TXA) in reducing blood loss and the consequent requirement of blood transfusion in the Indian population. METHODS This was a randomized controlled study of 100 patients with lower limb trauma. Fifty patients were given 1 g of TXA before surgery, and 50 patients were not given TXA. The requirement of blood transfusion, fall in Hb, the number of days admitted in the hospital after surgery were recorded, and evidence of deep vein thrombosis (DVT) was monitored. RESULTS Baseline demographics between the groups were comparable. The required blood transfusion and fall in Hb in patients receiving intra-operative TXA were significantly lower than those not given TXA (p < 0.0001). There was no significant difference in the length of hospital stay between the two groups (p = 0.6). There was no significant difference in the incidence of DVT in both groups. DISCUSSION TXA helps reduce the morbidity of trauma patients by reducing the requirement for blood transfusion. Its use is safe in lower limb trauma surgery and lowers the cost of therapy to the patient.
Optimizing effectivity of tranexamic acid in bilateral knee arthroplasty - a prospective randomized controlled study
The Knee. 2016;24((1):):100-106
INTRODUCTION Tranexamic acid (TEA) is used in reducing surgical blood loss. Literature shows no optimal regimen recommended for Bilateral Total Knee Arthroplasty (TKA). We evaluated three TEA regimens differing in dosage, timing and mode of administration in bilateral TKA to identify the most effective regimen to reduce blood loss. METHODS We prospectively studied three TEA regimens (25 patients each) as follows: (1) two intraoperative, intravenous doses (IOIO), (2) two intraoperative local applications (LALA), and (3) one preoperative plus two intraoperative, intravenous doses (POIOIO). Two independent parameters of drain loss and total blood loss, calculated by the hemoglobin balance method were statistically evaluated. RESULTS Mean drain loss was least (412.9ml) in the POIOIO group, greatest (607.2ml) in the IOIO group and LALA group in between (579.4ml), with a statistically significant difference among them (p=0.0022). On paired evaluation, the drain loss in the POIOIO group was significantly less as compared to the other two groups, whereas the difference between IOIO and LALA was not significant. Mean total blood loss was least in the POIOIO group (1207ml) and greatest in LALA group (1270ml). The difference among the groups was not statistically significant (p=0.80). There was no incidence of any thromboembolic phenomenon. On correlation with our study on Most Effective Regimen in Unilateral TKA, both results were found to substantiate each other.
A randomized controlled trial comparing lactulose plus albumin versus lactulose alone for treatment of hepatic encephalopathy
Journal of Gastroenterology and Hepatology. 2016;32((6):):1234-1239
BACKGROUND Hepatic encephalopathy (HE) is associated with poor prognosis and treatment of HE is primarily directed at the reduction of the blood ammonia levels. We evaluated the efficacy and safety of albumin plus lactulose versus lactulose alone for treatment of overt HE. METHODS In prospective randomized controlled trial, 120 patients with overt HE were randomized in 2 groups; group A lactulose plus albumin (n = 60) and group B, lactulose alone (n = 60). Primary end point was complete reversal of HE and secondary end points were mortality and hospital stay. RESULTS 120 patients (mean age 40.4 +/- 9.3 years) were included in study. 36 (30%) patients were in Child-Turcotte-Pugh (CTP) class B and 84 (70%) were in CTP Class C. Mean CTP score was 9.8 +/- 2.1 and MELD score was 26.1 +/- 5.3. 27 (22.5%) had grade 2, 57 (47.5%) had grade 3 and 36 (30%) had grade 4 HE at the time of admission. Forty five (75%) patients in group A compared to thirty two (53.3%) patients in group B had complete reversal of HE (p = 0.03). Mortality was significantly lower in lactulose plus albumin group [11(18.3%)] versus lactulose alone [19 (31.6%), (p < 0.05)]. There was significant decrease in levels of arterial ammonia, IL-6, IL-18, TNF-alpha and endotoxins after treatment in both groups however the delta decrease was significantly higher in group A compared to group B. Hospital stay was shorter in group A. CONCLUSIONS Combination of lactulose plus albumin is more effective than lactulose alone in treatment of overt HE. This article is protected by copyright. All rights reserved.