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Local Versus Systemic Tranexamic Acid in Total Hip Arthroplasty in Young Adults
Kushwaha NS, Singh S, Kumar S, Singh A, Abbas MB, Deshwal S, Agarwal R
Cureus. 2023;15(3):e36230
Abstract
Background Total hip arthroplasty (THA) is the most successful orthopedic elective surgical procedure for end-stage hip arthritis. THA is linked with significant blood loss, ranging from 1,188 to 1,651 mL, and a transfusion rate of 16-37%, which frequently results in postoperative blood transfusions. Postoperative blood transfusions can be avoided by using autologous blood transfusion, intraoperative blood saving, local anesthetic, hypotensive anesthesia, and antifibrinolytic medications such as tranexamic acid (TXA) administration. Methodology A double-blinded, placebo-controlled, randomized, controlled study was conducted with three prospective groups to investigate the efficacy of topical and systemic routes of a single intraoperative dose (1.5 g) of TXA. Patients were recruited from our center between October 2021 to March 2022 who were undergoing primary total hip replacement. Estimated blood loss was calculated and compared in groups, and a p-value of <0.05 was taken as significant. Results A total of 60 patients were recruited in our study. Estimated blood loss was similar in both treatment groups, 816.8 ± 219.9 mL in the systemic TXA group and 775.5 ± 107.2 mL in the topical TXA group. The placebo group had 1,066.3 ± 150.4 mL estimated blood loss, which was significantly higher compared to the treatment groups. Conclusions Administration of TXA (1.5 g) significantly lowers blood loss without increasing problems, which can eliminate concerns about intravenous TXA use. TXA reduces blood loss by 270 mL on average.
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Comparing Tubeless and Tubed Approaches in Percutaneous Nephrolithotomy for Moderate Renal Calculi: Outcomes on Safety, Efficacy, Pain Management, Recovery Time, and Cost-Effectiveness
Kr S, Singh A, Sharma P, Pai V, Choudhary A, Patil S
Cureus. 2023;15(5):e39211
Abstract
Introduction This study focuses on investigating the effect of routine nephrostomy tube placement in patients with moderate renal calculi of size 2.5 cm or less who undergo uncomplicated percutaneous nephrolithotomy (PCNL) procedures. Previous studies have not specified whether only uncomplicated cases were included in the analysis, which may affect the results. This study aims to provide a clearer understanding of the effect of routine nephrostomy tube placement on blood loss in a more homogeneous patient population. Materials and methods A prospective randomized controlled trial (RCT) was conducted at our department over 18 months, dividing 60 patients with a single renal or upper ureteric calculus of size ≤2.5 cm into two groups: 30 patients in each group (group 1: tubed PCNL, group 2: tubeless PCNL). The primary outcome was the drop in perioperative hemoglobin level and the number of packed cell transfusions necessary. The secondary outcome included the mean pain score, analgesic requirement, length of hospital stay, time to return to normal activities, and the total cost of the procedure. Results The two groups were comparable in age, gender, comorbidities, and stone size. The postoperative hemoglobin level was significantly lower in the tubeless PCNL group (9.56 ± 2.13 gm/dL) compared to the tube PCNL group (11.32 ± 2.35 gm/dL) (p = 0.0037), and two patients in the tubeless group required blood transfusion. The duration of surgery, pain scores, and analgesic requirement were comparable between the two groups. The total procedure cost was significantly lower in the tubeless group (p = 0.0019), and the duration of hospital stay and time to return to daily activities were significantly shorter in the tubeless group (p < 0.0001). Conclusions Tubeless PCNL is a safe and effective alternative to conventional tube PCNL, with the advantages of shorter hospital stay, faster recovery, and lower procedure costs. Tube PCNL is associated with less blood loss and the need for transfusions. Patient preferences and bleeding risk should be considered when choosing between the two procedures.
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A Randomised Controlled Trial to Compare Injection Ferric Carboxymaltose and Oral Iron in Treating Iron Deficiency Anemia During Pregnancy
Chawla S, Singh A, Jhamb D, Anupama CH
Journal of obstetrics and gynaecology of India. 2022;72(6):492-496
Abstract
INTRODUCTION Iron deficiency anemia (IDA) in pregnancy has a prevalence as high as 40-60% in different countries of the world. Oral iron is used to treat his commonest medical disorder in pregnancy. Ferrous sulphate is associated with considerable side effects. Ferric carboxymaltose (FCM) is a newer iron preparation which allows for single and higher dose (up to 1000 mg) of IV iron infusion. This study was conducted to compare the efficacy of FCM and FS in treating IDA during pregnancy. METHODS A randomised control trial was done at a tertiary care centres involving 362 women (181 women each in FS and FCM group). The pregnant anemic women with IDA were enrolled between 18 and 34 weeks of pregnancy. They were given 1000 mg of FCM iv as single dose or were given FS tablets twice daily (120 mg iron daily). The data were collected for rise in the Hb and serum ferritin over a period of 6 weeks. RESULTS Nine and 18 patients were lost to follow-up in the FCM and FS group, respectively. The data were analysed as per protocol analysis. FCM group women showed 2.6 gm% rise in Hb compared to 1.7 gm% of FS group. One hundred and sixty-six out of 172 women in FS group achieved anemia correction at 6 weeks. No difference was observed in the neonatal outcome. No major side effects were observed in the either group. CONCLUSION In our study, FCM was more effective than oral FS in increasing Hb in women with IDA during pregnancy. This clinical benefit with FCM was achieved without the concerns for safety and tolerability of the drug.
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Propranolol vs. band ligation for primary prophylaxis of variceal hemorrhage in cirrhotic patients with ascites: a randomized controlled trial
Singh V, Kumar P, Verma N, Vijayvergiya R, Singh A, Bhalla A
Hepatology international. 2022
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Abstract
BACKGROUND AND AIMS Recent studies have debated the utility of beta-blockers to prevent variceal hemorrhage (V.H.) in cirrhosis patients with ascites. We aimed to evaluate the safety and efficacy of propranolol (PPL) compared to endoscopic variceal ligation (EVL) for V.H. primary prevention in patients with ascites. METHODS Cirrhosis patients with ≥ grade 2 ascites and varices needing primary prophylaxis were randomly assigned to receive either PPL (n = 80) or EVL (n = 80). Patients were followed monthly until 12 months or transplant or death. The primary endpoint was 12-month transplant-free-survival (TFS). Secondary endpoints were the incidence of V.H., acute kidney injury (AKI), and control of ascites. RESULTS Baseline characteristics were similar between the groups. PPL-group had a lower 12-month TFS (76.0% vs. 89.7%; p = 0.02) as compared with EVL-group. Mean arterial pressure ≤ 82 mmHg and MELD-sodium were the independent predictors of mortality. Incidence of VH was comparable between PPL and EVL-groups [6 (7.5%) vs. 2 (2.5%), p = 0.13]. In PPL vs. EVL-group, more patients had worsening of ascites (15% vs. 5%; p = 0.03), developed refractory ascites (13.7% vs.3.7%; p = 0.02), relapse of ascites (37.1% vs. 16.4%, p < 0.01), and AKI (26.2% vs. 12.5%; p = 0.02). Side effects were comparable between the two groups. CONCLUSIONS Primary VH-prophylaxis with PPL is associated with lower survival, poor control of ascites, and increased risk of AKI in cirrhosis patients with ≥ grade 2 ascites. PPL and EVL are equally effective in preventing V.H. Serial monitoring of blood pressures and renal functions is needed in cirrhosis patients with ascites on PPL (NCT02649335).
PICO Summary
Population
Cirrhosis patients with ascites and esophageal varices (n= 160).
Intervention
Propranolol (PPL), (PPL group, n= 80).
Comparison
Endoscopic variceal ligation (EVL), (EVL group, n= 80).
Outcome
Patients receiving PPL had a lower 12-month transplant-free-survival (76.0% vs. 89.7%) compared with patients who had EVL. Mean arterial pressure ≤ 82 mmHg and MELD-sodium were the independent predictors of mortality. Incidence of variceal haemorrhage was comparable between the PPL and EVL groups [6 (7.5%) vs. 2 (2.5%)]. In the PPL vs. EVL group, more patients had worsening of ascites (15% vs. 5%), developed refractory ascites (13.7% vs. 3.7%), relapse of ascites (37.1% vs. 16.4%), and acute kidney injury (26.2% vs. 12.5%). Side effects were comparable between both groups.
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Tourniquet Use in Arthroscopic ACL Reconstruction: A Blinded Randomized Trial
Choudhary A, Kanodia N, Agrawal S, Bhasin VB., Singh A
Indian journal of orthopaedics. 2021;55(2):384-391
Abstract
INTRODUCTION Despite knowing, that tourniquet induces ischemia and soft tissue damage surgeons still use it. The purpose of this study is to compare post operative pain and quadriceps function in patients undergoing arthroscopy assisted ACL reconstruction with tourniquet and without tourniquet. METHODS A blinded randomized prospective trial conducted at Orthopaedic department of a tertiary institute in India from Feb 2019 to June 2019. 45 patients undergoing Arthroscopic ACL reconstruction aged between 18 and 60 years were recruited in the study according to selection criteria. Patients were distributed in 2 groups randomly, namely, tourniquet and non-tourniquet. Preoperatively serum CPK measurement and thigh girth measurement was done. Following standard arthroscopic procedure VAS score monitoring for pain was done for 5 days. Serum CPK levels were performed on postoperative day 1. Thigh girth was measured on postoperative day 21. RESULT Pain was significantly high in patients in whom tourniquet was used. VAS scores were significantly high in tourniquet group. Tourniquet group patients required more amount of additional analgesics in postoperative period (p < 0.001). Serum CPK levels were comparable preoperatively while significantly high postoperatively in tourniquet group (p < 0.001). Difference in mean of thigh girth was significant between the groups (p < 0.001) and there is difficulty experienced by patients in performing straight leg raise test after tourniquet use (p = 0.002). CONCLUSION Tourniquet use is associated with increased pain, analgesic requirement, damage to muscles and compromises muscle function in early postoperative period. This can not only lead to increased patient discomfort but also difficult initial rehabilitation. Arthroscopic procedures can be uneventfully performed without the use of a tourniquet, and alternative methods should be looked upon and emphasized.
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Safety and effectiveness of intravenous iron sucrose versus standard oral iron therapy in pregnant women with moderate-to-severe anaemia in India: a multicentre, open-label, phase 3, randomised, controlled trial
Neogi SB, Devasenapathy N, Singh R, Bhushan H, Shah D, Divakar H, Zodpey S, Malik S, Nanda S, Mittal P, et al
The Lancet. Global health. 2019;7(12):e1706-e1716
Abstract
BACKGROUND Intravenous iron sucrose is a promising therapy for increasing haemoglobin concentration; however, its effect on clinical outcomes in pregnancy is not yet established. We aimed to assess the safety and clinical effectiveness of intravenous iron sucrose (intervention) versus standard oral iron (control) therapy in the treatment of women with moderate-to-severe iron deficiency anaemia in pregnancy. METHODS We did a multicentre, open-label, phase 3, randomised, controlled trial at four government medical colleges in India. Pregnant women, aged 18 years or older, at 20-28 weeks of gestation with a haemoglobin concentration of 5-8 g/dL, or at 29-32 weeks of gestation with a haemoglobin concentration of 5-9 g/dL, were randomly assigned (1:1) to receive intravenous iron sucrose (dose was calculated using a formula based on bodyweight and haemoglobin deficit) or standard oral iron therapy (100 mg elemental iron twice daily). Logistic regression was used to compare the primary maternal composite outcome consisting of potentially life-threatening conditions during peripartum and postpartum periods (postpartum haemorrhage, the need for blood transfusion during and after delivery, puerperal sepsis, shock, prolonged hospital stay [>3 days following vaginal delivery and >7 days after lower segment caesarean section], and intensive care unit admission or referral to higher centres) adjusted for site and severity of anaemia. The primary outcome was analysed in a modified intention-to-treat population, which excluded participants who refused to participate after randomisation, those who were lost to follow-up, and those whose outcome data were missing. Safety was assessed in both modified intention-to-treat and as-treated populations. The data safety monitoring board recommended stopping the trial after the first interim analysis because of futility (conditional power 1.14% under the null effects, 3.0% under the continued effects, and 44.83% under hypothesised effects). This trial is registered with the Clinical Trial Registry of India, CTRI/2012/05/002626. FINDINGS Between Jan 31, 2014, and July 31, 2017, 2018 women were enrolled, and 999 were randomly assigned to the intravenous iron sucrose group and 1019 to the standard therapy group. The primary maternal composite outcome was reported in 89 (9%) of 958 patients in the intravenous iron sucrose group and in 95 (10%) of 976 patients in the standard therapy group (adjusted odds ratio 0.95, 95% CI 0.70-1.29). 16 (2%) of 958 women in the intravenous iron sucrose group and 13 (1%) of 976 women in the standard therapy group had serious maternal adverse events. Serious fetal and neonatal adverse events were reported by 39 (4%) of 961 women in the intravenous iron sucrose group and 45 (5%) of 982 women in the standard therapy group. At 6 weeks post-randomisation, minor side-effects were reported by 117 (16%) of 737 women in the intravenous iron sucrose group versus 155 (21%) of 721 women in the standard therapy group. None of the serious adverse events was found to be related to the trial procedures or the interventions as per the causality assessment made by the trial investigators, ethics committees, and regulatory body. INTERPRETATION The study was stopped due to futility. There is insufficient evidence to show the effectiveness of intravenous iron sucrose in reducing clinical outcomes compared with standard oral iron therapy in pregnant women with moderate-to-severe anaemia. FUNDING WHO, India.
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Impact of higher hemoglobin targets on blood pressure and clinical outcomes: a secondary analysis of CHOIR
Inrig JK, Sapp S, Barnhart H, Patel UD, Reddan D, Singh A, Califf RM, Szczech L
Nephrology Dialysis Transplantation. 2012;27((9):):3606-14.
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Abstract
BACKGROUND Targeting a higher hemoglobin in patients with chronic kidney disease leads to adverse cardiovascular outcomes, yet the reasons remain unclear. Herein, we sought to determine whether changes in erythropoiesis-stimulating agent (ESA) dose and in hemoglobin were predictive of changes in blood pressure (BP) and whether these changes were associated with cardiovascular outcomes. METHODS In this secondary analysis of 1421 Correction of Hemoglobin and Outcomes in Renal Disease (CHOIR) participants, mixed model analyses were used to describe monthly changes in ESA dose and hemoglobin with changes in diastolic BP (DBP) and systolic BP (SBP). Poisson modeling was performed to determine whether changes in hemoglobin and BP were associated with the composite end point of death or cardiovascular outcomes. RESULTS Monthly average DBP, but not SBP, was higher in participants in the higher hemoglobin arm. Increases in ESA doses and in hemoglobin were significantly associated with linear increases in DBP, but not consistently with increases in SBP. In models adjusted for demographics and comorbid conditions, increases in ESA dose (>0 U) and larger increases in hemoglobin (>1.0 g/dL/month) were associated with poorer outcomes [event rate ratio per 1000 U weekly dose per month increase 1.05, (1.02-1.08), P = 0.002 and event rate ratio 1.70 (1.02-2.85), P = 0.05, respectively]. However, increasing DBP was not associated with adverse outcomes [event rate ratio 1.01 (0.98-1.03), P = 0.7]. CONCLUSION Among CHOIR participants, higher hemoglobin targets, increases in ESA dose and in hemoglobin were associated both with increases in DBP and with higher event rates; however, increasing DBP was not associated with adverse outcomes.
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Effect of tranexamic acid on blood loss and transfusion requirement in total knee replacement in the Indian population: a case series
Gautam PL, Katyal S, Yamin M, Singh A
Indian Journal of Anaesthesia. 2011;55((6):):590-3.
Abstract
CONTEXT Total knee replacement (TKR) is often carried out using a tourniquet to minimize intraoperative blood loss. However, its application enhances local fibrinolysis, resulting in excessive blood loss during the post-operative period. Fibrinolytic profile varies in different regions and races. Tranexamic acid has been shown to reduce post-operative blood loss and the need for transfusion in TKR. However, there is paucity of literature from the Indian population and the efficacy of the agent has not been tested in Indian patients undergoing TKR. AIMS Effect of tranexamic acid on blood loss in TKR surgery in the Indian population. SETTING AND DESIGN In this double-blinded study, 40 patients undergoing unilateral TKR were randomly divided into two groups. METHODS All patients were conducted under spinal anaesthesia using injection bupivacaine 0.5% heavy 12-15 mg. The treatment group received 10 mg/kg tranexamic acid, intravenous (IV), half an hour before deflation of the tourniquet, with a second dose of 2 mg/kg administered 3 hours after the first dose. The exact protocol was followed for the placebo group, except that normal saline was used instead of tranexamic acid. Blood loss, blood transfusion details and change in haemoglobin levels were noted. STATISTICAL ANALYSIS Student's paired 't' test was used in statistical analysis. RESULTS The mean post-operative blood loss in the tranexamic acid group was 272.5+/-122.5 ml (mean+/-SD), and 685+/-118.2 ml in the placebo group (P<0.001). The total blood loss was lower in the tranexamic acid group than in the placebo group (427.6 ml vs. 911.6 ml; P<0.001). The absolute number of blood transfusions and the number of patients who required transfusions were lower in the tranexamic acid group than in the placebo group. None of the patients had any side or adverse effect. CONCLUSIONS Tranexamic acid significantly decreases post-operative blood loss and reduces the need for blood transfusion in patients undergoing TKR.