Abstract

BACKGROUND High volume plasma-exchange (HVPE) improves survival in patients with acute liver failure (ALF), but apprehension regarding volume overload and worsening of cerebral edema remain. METHODS In an open-label randomized controlled trial, 40 consecutive patients of ALF were randomized 1:1 to either standard medical treatment (SMT) or SMT with standard-volume plasma-exchange (SVPE). SVPE was performed using centrifugal apheresis [target volume of 1.5 to 2.0 plasma volumes per session] until desired response was achieved. Cerebral edema was assessed by brain imaging. Results were analyzed in an intention-to-treat analysis. Primary outcome was 21-day transplant-free survival. The levels of cytokines, damage-associated molecular patterns (DAMPs) and endotoxins were analyzed at baseline and day 5. RESULTS ALF patients [aged 31.5 ± 12.2 years, 60% male, 78% viral, 83% hyperacute, 70% with SIRS were included. At day 5, SVPE [mean sessions 2.15 ± 1.42, median plasma volume replaced 5.049 L] compared to SMT alone, resulted in higher lactate clearance (p = .02), amelioration of SIRS (84% vs. 26%; P = .02), reduction in ammonia levels [(221.5 ± 96.9) vs.(439 ± 385.6) μg/dl, P = .02) and SOFA scores [9.9(±3.3) vs. 14.6(±4.8); P = .001]. There were no treatment related deaths. SVPE was associated with a higher 21-day transplant free-survival [75% vs. 45%; P = .04, HR 0.30, 95%CI 0.01-0.88]. A significant decrease in levels of pro-inflammatory cytokines and an increase in anti-inflammatory cytokines along with a decrease in endotoxin and DAMPs was seen with SVPE. CONCLUSION In ALF patients with cerebral edema, SVPE is safe and effective and improves survival possibly by a reduction in cytokine storm and ammonia. CLINICALTRIAL gov (identifier: NCT02718079).

Abstract

This review article aimed to determine the obstetric and maternal outcomes after B-Lynch compression sutures to control atonic postpartum hemorrhage (PPH). This meta-analysis was performed after registering the protocol in the PROSPERO database with the registration number CRD42022355358. Two independent reviewers systematically searched electronic databases and search engines (PubMed, Cochrane Library, and Google Scholar) to retrieve published articles from inception to July 2022. The obstetric and maternal outcomes after the B-Lynch compression suture were computed using the random-effects model in pooled proportion with a 95% confidence interval (CI). Meta-regression analysis and subgroup analysis were performed to explain any source of possible heterogeneity. Quality assessment of the included studies was done using Joanna Briggs Institute (JBI) tools which are critical appraisal tools for systematic reviews and meta-analyses. This meta-analysis included a total of 30 studies involving 1,270 subjects. The pooled proportion of B-Lynch suture alone was 91% (95% CI = 82-97%). The combined proportion of B-Lynch suture plus another compression suture was 1% (95% CI = 0-3%), and the pooled proportion of B-Lynch suture plus vessel ligation was 3% (95% CI = 1-6%). The pooled proportions of PPH controlled and hysterectomies were 94% (95% CI = 91-97%, I(2) = 65.3%) and 7% (95% CI = 4-10%, I(2) = 72.13%), respectively. Therefore, B-Lynch suture (either alone or in combination with other techniques) is a simple and effective measure to control atonic PPH.

Abstract

BACKGROUND AND AIM The choice of resuscitation fluid in cirrhosis patients with sepsis-induced hypotension (SIH) is unclear. 5% albumin has been superior to normal saline in the FRISC study. We compared the efficacy and safety of 20% albumin, which has greater oncotic properties with plasmalyte in reversing SIH. METHODS Critically-ill cirrhosis(CIC) patients underwent open-label randomization to receive either 20% albumin [0.5-1.0gm/kg over 3 hours; n=50] or plasmalyte (30ml/kg over 3 hours, n=50). The primary end-point of the study was the attainment of mean arterial pressure (MAP) above 65 mmHg at three hours. RESULTS Baseline characteristics were comparable in albumin and plasmalyte groups; arterial lactate(mmol/L) [6.16±3.18 vs. 6.38±4.77; p=0.78), MAP (mmHg) [51.4±6.52 vs. 49.9±4.45; p=0.17] and SOFA score [10.8±2.96 vs. 11.1±4.2; p=0.68] respectively. Most patients were alcoholics (39%) and had pneumonia (40%). In the intention-to-treat (ITT) analysis, albumin was superior to plasmalyte in achieving the primary end-point (62% vs. 22%; p<0.001). A rapid decline in arterial lactate (P=0.03), a lesser proportion of dialysis [48% vs. 62%; p=0.16], and a higher time to initiation of dialysis (in hours) [68.13±47.79 vs. 99.7± 63.4; p=0.06] was seen with albumin. However, the 28-day mortality was not different (58% vs. 62%, p=0.57). Patients in the albumin group required discontinuation of therapy in 11 (22%) patients due to adverse effects compared to none in plasmalyte group. CONCLUSION In patients with cirrhosis and SIH, 20% albumin transiently improves the hemodynamics with early lactate clearance than plasmalyte but needs monitoring as it is more often attended with pulmonary complications. Both fluids provide comparable 28 days survival. NCT02721238 LAY SUMMARY The current randomized controlled trial performed in critically ill patients with cirrhosis and sepsis-induced hypotension highlights that 20% albumin restores hemodynamics but causes more pulmonary complications than plasmalyte. The impact on renal functions was also modest. These effects did not result in improvement in deaths at 28-days. Plasmalyte is safer and well-tolerated and can be considered for volume resuscitation in patients with cirrhosis and sepsis-induced hypotension.

Abstract

AIMS AND OBJECTIVES To measure the additional effect of platelet-rich plasma (PRP) on functional outcome of anterior cruciate ligament tear managed by augmenting anterior cruciate ligament (ACL) reconstruction with PRP. METHODS The present study was conducted on patients with ACL tear admitted in the department of orthopaedics, King George's Medical University, Lucknow wherein a total of 70 subjects were assigned into two groups of 35 patients each randomly, viz Group 1 in which the patients were treated by quadruple hamstring graft alone and Group 2 in which the patients were treated with augmented hamstring graft with PRP. The standardized anterior drawer test, Lachman's test, Lysholm knee score were quantified both preoperatively and postoperatively at different follow-ups and also tibial tunnel widening was measured postoperatively at different follow-ups. RESULT The present study had 70 patients with ACL tears. The mean age of patients in non-PRP groups was 29.71 ±2.99 years while that in the PRP group was 28.34±4.32 years. On comparing the improvement in grades at pre-op, immediate postop, 6 weeks, and 3 months follow-ups, there was no statistically significant difference between the two groups. The tibial tunnel widening also showed no significant difference between the two groups. CONCLUSION In our study, it was found that both the groups showed improvements in grades of anterior drawer test and Lachman's test postoperatively but the difference between both the groups was not significant. Similarly, while comparing the improvements in Lysholm knee score and tibial tunnel widening among both the groups, the difference was not significant. Follow up of 3 months was a limiting factor in our study. This technique needs further clinical evaluation to assess the long-term results.

Abstract

BACKGROUND Tranexamic acid (TA) is used to control bleeding in patients with hemoptysis. However, the effectiveness of the different routes of TA administration has not been studied. RESEARCH QUESTION Does nebulized route of Tranexamic Acid (TA) administration reduce the amount of hemoptysis compared to intravenous route in patients presenting to emergency department (ED) with hemoptysis? METHODS We conducted a pragmatic, open labelled, cluster randomized, parallel single centered pilot trial of nebulized TA (500mg tid) versus intravenous TA (500mg tid) in adult patients presenting to emergency department with active hemoptysis. The primary outcome was cessation of bleeding at 30 min. Secondary outcome included amount of hemoptysis at 6h, 12h and 24 h; interventional procedures and side effects of TA. Patients who were hemodynamically unstable or requiring immediate interventional procedure or mechanical ventilation were excluded from the study. RESULTS Of the 55 patients in each arm, hemoptysis cessation at 30 minutes after TA administration was significantly higher in nebulized arm (n=40) compared to intravenous arm (n=28) [X2 (1, n=110)=5.55, p=0.0019]. Also, hemoptysis amount reduced significantly in nebulization arm at all time periods of observation (P value 30min=0.011, at 6h=0.002, 12h=0.0008, 24h=0.005). Fewer patients in nebulized arm required bronchial artery embolization (13 vs 21, P value=0.024) and thereby higher discharge rates from the ED (67.92% vs 39.02%, P value=0.005). Two patients in nebulized arm had asymptomatic bronchoconstriction which resolved after short acting beta agonist nebulization. No patient discharged from ED underwent any interventional procedure or revisited the ED with rebleed during the 72 hours follow up period. INTERPRETATION Nebulized TA may be more efficacious than intravenous TA in reducing the amount of hemoptysis and need for ED interventional procedures. Future larger studies are needed to further explore the potential of nebulized TA compared to intravenous TA in patients with mild hemoptysis.

Abstract

PURPOSE Pseudoaneurysms are one of the rare complications that can be encountered after the orthognathic surgery. We are presenting a new case of pseudoaneurysm of bilateral sphenopalatine artery after Bijaw Surgery in a young male and a systematic review of all the cases in the literature emphasizing on signs and symptoms, epistaxis or bleeding episodes and treatment outcomes. METHODS A systematic research strategy was planned according to the PRISMA guidelines, and articles were taken from 1986 to September, 2019. A total of 899 articles were selected for screening, out of which only 26 articles met our inclusion and exclusion criteria. These were included in the study for qualitative analysis. RESULTS Most PAs were associated with Lefort I osteotomy (69.7%), followed by sagittal split osteotomy (24.24%). Average intraoperative blood was 635 ml. Maximum number of episodes of epistaxis/swelling or bleeding occurred in second week. Mean bleeding episodes were 2.58 ± 0.996. The arteries commonly affected were internal maxillary artery (42%), sphenopalatine artery (27.27%), facial artery (15.15%), descending palatine artery (12.12%), internal carotid artery (9.09%) and infraorbital artery (3.03%). Embolization was treatment of choice in 81.81% cases. CONCLUSION If a patient has recurrent epistaxis or swelling after orthognathic surgery, it is advisable to go for diagnostic imaging like angiography without any delay. In recent times, advanced techniques and expertise are readily available for early diagnosis and management of pseudoaneurysm.

Abstract

PURPOSE To evaluate outcomes following trans-arterial embolization of hypervascular appendicular bony tumors in patients undergoing orthopedic resection by performing a systematic review including data from the authors' institution. MATERIALS AND METHODS From April 2008 to August 2018, 73 patients (59 males, mean age 58.1 years) with musculoskeletal tumors presented for embolization for preoperative devascularization prior to orthopedic surgery. A retrospective chart review was performed to identify demographic, procedural and surgical data. A systematic review of the Pubmed, Medline, and Web of Science databases was performed to identify studies in which pre-operative embolization was performed of appendicular MSK tumors, and with measurements of estimated blood loss. All the variables listed above were recorded. A patient level analysis was performed to determine average estimated blood loss. RESULTS 58 patients (47 men, 11 women, range 21-84 years) were included in our institutional analysis. The median EBL was 500 mL (range 100-3000). There was no difference in EBL between RCC (719.6 ± 626.1) and non-RCC groups (855.6 ± 657.5); p = 0.44. The median intra-operative transfusion requirement was 1.0 unit (range 0-8 ± 2.06). From 1984 to 2015, 9 studies were identified that provided data for a total of 118 patients (46 males, 42 females, range 10-82 years). The mean and median post-surgical EBL across all patients was 976.9 ± 78.5 (SE) and 725 mL (range 10-7000), respectively. There were no complications related to non-target embolization. CONCLUSION Preoperative trans-arterial embolization of hypervascular MSK neoplasms appears to be safe and effective in minimizing peri- and post-operative bleeding while keeping transfusion requirements low.

Abstract

BACKGROUND Thrombosis and inflammation may contribute to morbidity and mortality among patients with coronavirus disease 2019 (Covid-19). We hypothesized that therapeutic-dose anticoagulation would improve outcomes in critically ill patients with Covid-19. METHODS In an open-label, adaptive, multiplatform, randomized clinical trial, critically ill patients with severe Covid-19 were randomly assigned to a pragmatically defined regimen of either therapeutic-dose anticoagulation with heparin or pharmacologic thromboprophylaxis in accordance with local usual care. The primary outcome was organ support-free days, evaluated on an ordinal scale that combined in-hospital death (assigned a value of -1) and the number of days free of cardiovascular or respiratory organ support up to day 21 among patients who survived to hospital discharge. RESULTS The trial was stopped when the prespecified criterion for futility was met for therapeutic-dose anticoagulation. Data on the primary outcome were available for 1098 patients (534 assigned to therapeutic-dose anticoagulation and 564 assigned to usual-care thromboprophylaxis). The median value for organ support-free days was 1 (interquartile range, -1 to 16) among the patients assigned to therapeutic-dose anticoagulation and was 4 (interquartile range, -1 to 16) among the patients assigned to usual-care thromboprophylaxis (adjusted proportional odds ratio, 0.83; 95% credible interval, 0.67 to 1.03; posterior probability of futility [defined as an odds ratio <1.2], 99.9%). The percentage of patients who survived to hospital discharge was similar in the two groups (62.7% and 64.5%, respectively; adjusted odds ratio, 0.84; 95% credible interval, 0.64 to 1.11). Major bleeding occurred in 3.8% of the patients assigned to therapeutic-dose anticoagulation and in 2.3% of those assigned to usual-care pharmacologic thromboprophylaxis. CONCLUSIONS In critically ill patients with Covid-19, an initial strategy of therapeutic-dose anticoagulation with heparin did not result in a greater probability of survival to hospital discharge or a greater number of days free of cardiovascular or respiratory organ support than did usual-care pharmacologic thromboprophylaxis. (REMAP-CAP, ACTIV-4a, and ATTACC ClinicalTrials.gov numbers, NCT02735707, NCT04505774, NCT04359277, and NCT04372589.).

Abstract

OBJECTIVES To determine the efficacy of tranexamic acid in decreasing blood loss in elective/emergency LSCS. MATERIALS AND METHODS A prospective randomised case control study was done in 200 pregnant women undergoing elective/emergency LSCS in the Department of Obstetrics and Gynaecology, at a tertiary care teaching hospital in Mysuru, from December 2018 to September 2019. Women in the age group of 18-35 years were included in the study. Those with anaemia (Hb < 10 gm%), hypertension in pregnancy, bleeding diathesis, GDM on insulin, polyhydramnios, oligohydramnios, cardiac and chronic liver disorders were excluded from the study. Two hundred women undergoing emergency/elective LSCS were divided into case (group 1) or control (group 2) groups using a computer-generated random number table. Tranexamic acid (10 mg/Kg) was given in 100 ml Normal Saline 10 mins prior to skin incision to women in the first group, along with routine care (10 Units of Oxytocin IM soon after extraction of the baby). Routine care, as per institutional protocol, was followed in the second group. The primary outcome was to estimate the intraoperative blood loss. Blood loss was measured by weighing pads, mops, drapes before and after surgery and blood in the suction container after surgery. Two separate suction catheters and containers were used, in order to minimise mixing of blood and amniotic fluid. Total blood loss was calculated as the difference in the weight of the pads, mops and drapes before and after surgery and the sum of the amount of blood in suction container. The difference between the pre-operative and post-operative haemoglobin and haematocrit was compared. The pre-operative, intra-operative and post-operative hemodynamics were also compared. RESULTS Statistical analysis was done using MS Excel and R-3.5.1 software. Unpaired and paired t test were used. In our study, there was a significant decrease in intraoperative bleeding in women receiving tranexamic acid. Women in the control group had a significant fall in the postoperative hemoglobin when compared to women who received tranexamic acid. Also, women who received tranexamic acid did not develop any significant hemodynamic changes during or immediately after the surgery. CONCLUSION Tranexamic acid can be safely used as a prophylactic agent to reduce bleeding during elective and emergency LSCS.

Abstract

BACKGROUND Mortality from COVID-19 is high among hospitalized patients and effective therapeutics are lacking. Hypercoagulability, thrombosis and hyperinflammation occur in COVID-19 and may contribute to severe complications. Therapeutic anticoagulation may improve clinical outcomes through anti-thrombotic, anti-inflammatory and anti-viral mechanisms. Our primary objective is to evaluate whether therapeutic-dose anticoagulation with low-molecular-weight heparin or unfractionated heparin prevents mechanical ventilation and/or death in patients hospitalized with COVID-19 compared to usual care. METHODS An international, open-label, adaptive randomized controlled trial. Using a Bayesian framework, the trial will declare results as soon as pre-specified posterior probabilities for superiority, futility, or harm are reached. The trial uses response-adaptive randomization to maximize the probability that patients will receive the more beneficial treatment approach, as treatment effect information accumulates within the trial. By leveraging a common data safety monitoring board and pooling data with a second similar international Bayesian adaptive trial (REMAP-COVID anticoagulation domain), treatment efficacy and safety will be evaluated as efficiently as possible. The primary outcome is an ordinal endpoint with three possible outcomes based on the worst status of each patient through day 30: no requirement for invasive mechanical ventilation, invasive mechanical ventilation or death. CONCLUSION Using an adaptive trial design, the Anti-Thrombotic Therapy To Ameliorate Complications of COVID-19 trial will establish whether therapeutic anticoagulation can reduce mortality and/or avoid the need for mechanical ventilation in patients hospitalized with COVID-19. Leveraging existing networks to recruit sites will increase enrollment and mitigate enrollment risk in sites with declining COVID-19 cases.