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Efficacy of tranexamic acid in decreasing primary hemorrhage in transurethral resection of the prostate: A novel combination of intravenous and topical approach
Gupta A, Priyadarshi S, Vyas N, Sharma G
Urology annals. 2021;13(3):238-242
Abstract
BACKGROUND Transurethral resection of the prostate (TURP) is the gold standard for benign prostatic enlargement; however, hemorrhage still remains one of the major complications. OBJECTIVE The primary aim of this study was to evaluate the effect of tranexamic acid (TXA) in reducing intraoperative blood loss and need for blood transfusion. Secondary parameters compared were operating time, volume of irrigation fluid used, and reduction in hemoglobin concentration. SUBJECTS AND METHODS A total of 70 eligible patients undergoing TURP were randomized based on computer generated table into two groups. The study group (1) received IV TXA 500 mg after induction of anesthesia and 500 mg in each irrigation fluid bottle (dual mode) and the control group (2) received none. RESULTS The mean age (68.20 vs. 66.5 years), prostate size (57 vs. 51 g), and preoperative hemoglobin (13.3 vs. 13.5 g/dl) were similar between the groups. Intraoperative blood loss in the TXA group was found to be significantly reduced (174.60 ± 125.38 ml vs. 232.47 ± 116.8; P = 0.04). Blood transfusion was required in 2.8% of cases as compared to 14.2% in controls. Operating time, volume of irrigation fluid, and postoperative reduction of hemoglobin were not significant between the groups. No complications were observed in both groups. CONCLUSION In this study, we observed that TXA, when used as a combination of Intravenous and topical route, effectively reduced intra-operative blood loss and the need for transfusion.
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2.
Intravenous compared with oral iron for the treatment of iron-deficiency anemia in pregnancy: a systematic review and meta-analysis
Lewkowitz AK, Gupta A, Simon L, Sabol BA, Stoll C, Cooke E, Rampersad RA, Tuuli MG
Journal of perinatology : official journal of the California Perinatal Association. 2019
Abstract
OBJECTIVE To assess the effect of intravenous versus oral iron on hematologic indices and clinical outcomes for iron-deficiency anemia (IDA) in pregnancy. STUDY DESIGN Searches in Ovid Medline, Embase, SCOPUS, Cochrane Database, and ClinicalTrials.gov identified randomized-controlled trials comparing intravenous to oral iron for treating IDA in pregnancy. Primary outcomes were maternal hematologic indices at delivery. Secondary outcomes were blood transfusion, cesarean delivery, neonatal outcomes, and medication reactions. RESULTS Of 15,637 studies, 20 randomized trials met inclusion criteria and were analyzed. Mean hemoglobin at delivery (9 studies: WMD 0.66 g/dL (95% confidence Interval 0.31 -1.02 g/dL)) was significantly higher after intravenous iron therapy. Intravenous iron was associated with higher birthweight (8 studies: WMD 58.25 g (95% CI: 5.57-110.94 g)) but no significant differences in blood transfusion, cesarean delivery, or neonatal hemoglobin. There were fewer medication reactions with intravenous iron (21 studies: RR 0.34% (95% CI: 0.20-0.57)). CONCLUSION Intravenous iron therapy is associated with higher maternal hemoglobin at delivery with no difference in blood transfusion and fewer mild medication reactions.
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3.
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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4.
Randomized trial to assess safety and clinical efficacy of intensive blood pressure reduction in acute spontaneous intracerebral haemorrhage
Gupta S, Abbot A K, Srinath R, Tewari A K, Gupta A, Gorthi S P, Narayanan C S, Totlani S I, Sirohi Y S, Anadure R
Medical Journal, Armed Forces India. 2018;74((2)):120-125.
Abstract
Background: Haematoma expansion due to raised blood pressure in spontaneous intracerebral haemorrhage may determine outcome. The aim of this study was to determine safety and efficacy of lowering blood pressure in acute spontaneous intracerebral haemorrhage. Methods: This open label, multicentric trial randomized patients ≥18 years with spontaneous intracerebral haemorrhage with no secondary cause within 72 h of onset to tight BP control arm where treatment was initiated if mean arterial pressure (MAP) was ≥115 mm of Hg and conventional BP control arm where treatment was initiated if MAP was ≥130 mm of Hg. The MAP was maintained in the respective arm for another 72 h after which both arms had MAP below 115 mm of Hg. Primary outcome was modified Rankin Scale at 90 days. Results: 118 patients, 59 in each arm were included. Follow up was available for all. Baseline characteristics were similar. At 90 days there was no significant difference between median mRS between the two arms. Odds Ratio for "poor outcome" (mRS 3-6) in the tight control arm (safety of the intervention) against "good outcome" (mRS 0-2) was not significant (OR 0.70 [95% CI 0.34-1.47] p = 0.35). Efficacy of the intervention in the form of Odds Ratio for "good outcome" in the tight control arm was not significant (OR 1.43 [95% CI 0.68-2.99], p = 0.35). Conclusion: In patients with spontaneous intracerebral haemorrhage who present within 72 h of the onset of symptoms, MAP can be safely lowered if it crosses 115 mm of Hg but it does not improve clinical outcome.
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5.
Ferric pyrophosphate citrate administered via dialysate reduces erythropoiesis-stimulating agent use and maintains hemoglobin in hemodialysis patients
Gupta A, Lin V, Guss C, Pratt R, Ikizler TA, Besarab A
Kidney International. 2015;88((5)):1187-94.
Abstract
Ferric pyrophosphate citrate (FPC) is a water-soluble iron salt administered via dialysate to supply iron directly to transferrin. The PRIME study tested whether treatment with FPC could reduce prescribed erythropoiesis-stimulating agent (ESA) use and maintain hemoglobin in hemodialysis patients. This 9-month, randomized, placebo-controlled, double-blind, multicenter clinical study included 103 patients undergoing hemodialysis 3-4 times weekly. The FPC group received dialysate containing 2mumol/l of iron. The placebo group received standard dialysate. A blinded central anemia management group facilitated ESA dose adjustments. Intravenous iron was administered according to the approved indication when ferritin levels fell below 200mug/l. The primary end point was the percentage change from baseline in prescribed ESA dose at end of treatment. Secondary end points included intravenous iron use and safety. At the end of treatment, there was a significant 35% reduction in prescribed ESA dose in FPC-treated patients compared with placebo. The FPC patients used 51% less intravenous iron than placebo. Adverse and serious adverse events were similar in both groups. Thus, FPC delivered via dialysate significantly reduces the prescribed ESA dose and the amount of intravenous iron needed to maintain hemoglobin in chronic hemodialysis patients.
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6.
A randomised controlled trial to compare intravenous iron sucrose and oral iron in treatment of iron deficiency anemia in pregnancy
Gupta A, Manaktala U, Rathore AM
Indian Journal of Hematology & Blood Transfusion. 2014;30((2):):120-5.
Abstract
The aim of this study was to compare the efficacy and safety of intravenous iron sucrose with oral iron therapy in pregnant patients with anemia. The primary outcome of the study was increase in haemoglobin on day 7, 14 & 28 and rise of serum ferritin over 28 days. The study population consisted of 100 patients with singleton pregnancy between 24 and 34 weeks, hemoglobin levels between 7.0-9.0 gm/dL and serum ferritin levels less than 15 ng/mL. The participants in the oral group were given daily 180 mg elemental iron in three divided oral doses for 4 weeks. Total calculated dose of iron sucrose with a target hemoglobin of 11 gm %, was given in 200 mg dose on alternate days. Mean haemoglobin rise was 0.58 gm/dL in the IV group as compared to 0.23 gm/dL in the oral group on day 14 and 1.9 gm/dL in the IV group & 1.3 gm/dL in the oral group on day 28, (p <0.05). In the IV group, 76% of the subjects achieved haemoglobin levels of >11 gm% at the time of delivery, as compared to only 54% of the subjects in the oral group who achieved these levels. Serum ferritin value was significantly higher in the IV group, 37.45 + 5.73 ng/mL as compared to 13.96 + 1.88 ng/mL in the oral group at 4th week (p <0.001). There was no major side effect in the IV group. 36% subjects in the oral group developed gastrointestinal side effects & 10% of the subjects were non compliant. The rate of hemoglobin rise is faster with intravenous iron sucrose therapy as compared to oral iron therapy which can be beneficial in pregnant women presenting with anemia at a later period of gestation. Intravenous iron sucrose is very well tolerated during pregnancy.
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7.
A randomised double-blind study comparing sodium feredetate with ferrous fumarate in anaemia in pregnancy
Sarkate P, Patil A, Parulekar S, Rege NN, Samant BD, Lokhande J, Gupta A, Kulkarni K
Journal of the Indian Medical Association. 2007;105((5):):278, 280-1, 284.
Abstract
Iron deficiency anaemia is a major health problem in India especially in women of reproductive age group. The World Health Organisation recommends that the haemoglobin concentration should not fall below 11. 0 g/dl at any time during pregnancy. The aim of study was to compare the efficacy and safety of two doses of sodium feredetate with ferrous fumarate in improving haemoglobin profile in pregnant anaemic women. Pregnant women with gestation period between 12 and 26 weeks having serum haemoglobin < 10 g/dl, serum ferritin levels less than 12 microg/l were included in the study. Patients were divided into 3 groups and drugs administered accordingly. A total of 48 patients were available for analysis which included 37 patients who had completed all the visits up to 75 days follow-up and 11 patients who were treatment failures. In group A combination of sodium feredetate (containing 33 mg of elemental iron) along with vitamin B12 (15 microg) and folic acid (1. 5 mg) was administered twice a day. In group B combination of sodium feredetate (containing 66 mg of elemental iron) along with vitamin B12 (15 microg) and folic acid (1. 5 mg) was administered twice a day. In group C combination of ferrous fumarate (containing 100 mg of elemental iron) along with vitamin B12 (15 microg) and folic acid (1. 5 mg) was administered twice a day. Patients were evaluated for Hb, RBC count, MCV, MCH and MCHC at day 0, 30, 45, 60 and 75. Serum ferritin, serum iron, TIBC and transferrin saturation were assessed at recruitment and end study. Mean rise of haemoglobin at the completion of study, over that of basal values was 1. 79 g/dl (0. 71 to 2. 87, 95% CI, p < 0. 05) in group A, 1. 84 g/dl (0. 82 to 2. 86, 95% CI, p < 0. 05) in group B and 1. 63 g/dl (0. 38 to 2. 88, 95% CI, p < 0. 05) in group C. Safety assessment was done by doing liver and kidney function test at the time of recruitment and end study. Low doses of sodium feredetate (33 mg and 66 mg of elemental iron given twice daily) produce comparable results as higher dose of ferrous fumarate (100 mg elemental iron given twice daily). As there were no adverse effects reported with sodium feredetate, it can be concluded from this study that this new formulation appears to be effective in improving haemoglobin profile in pregnant anaemic women and is tolerated well.
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8.
Fibrin glue versus N-butyl-2-cyanoacrylate in corneal perforations
Sharma A, Kaur R, Kumar S, Gupta P, Pandav S, Patnaik B, Gupta A
Ophthalmology. 2003;110((2):):291-8.
Abstract
OBJECTIVE To compare the efficacy of fibrin glue and N-butyl-2-cyanoacrylate in corneal perforations. DESIGN Randomized, controlled clinical trial. PARTICIPANTS Forty-one patients (41 eyes) with corneal perforations up to 3 mm in diameter with a positive Seidel's test were randomly assigned to two groups (1 and 2). INTERVENTION Group 1 comprised 19 eyes treated with fibrin glue, and group 2 comprised 22 eyes treated with N-butyl-2-cyanoacrylate. MAIN OUTCOME MEASURES Number of eyes with successful healing, time required for healing, status of corneal vascularization, and complications were compared in the two groups. Power calculation was performed at alpha = 0. 05. RESULTS Fifteen (79%) eyes had successful healing of corneal perforation in group 1, compared with 19 (86%) eyes in group 2 (P > 0. 05) at 3 months' follow-up. The power to detect a difference between the two groups was 10%. Corneal perforation healed within 6 weeks in 12 (63%) eyes in group 1 and 7 (31. 8%) eyes in group 2 (P < 0. 05). Reapplication of glue was required in six (31. 5%) eyes in group 1 and seven (31. 4%) eyes in group 2 during the first 3 months of follow-up. The mean number of applications per eye was 1. 37 in group 1 and 1. 36 in group 2. An increase in deep corneal vascularization was observed in 2 (10. 5%) eyes in group 1 and 10 (45. 5%) eyes in group 2 (P < 0. 05). Giant papillary conjunctivitis occurred in one (5%) eye in group 1 and eight (36. 4%) eyes in group 2 (P < 0. 05). CONCLUSIONS Fibrin glue and cyanoacrylate tissue adhesive are both effective in the closure of corneal perforations up to 3 mm in diameter. Fibrin glue provides faster healing and induces significantly less corneal vascularization, but it requires a significantly longer time for adhesive plug formation.
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9.
Optimization of epoetin therapy with intravenous iron therapy in hemodialysis patients
Besarab A, Amin N, Ahsan M, Vogel SE, Zazuwa G, Frinak S, Zazra JJ, Anandan JV, Gupta A
Journal of the American Society of Nephrology. 2000;11((3):):530-8.
Abstract
Iron deficiency limits the efficacy of recombinant human erythropoietin (rhEPO) therapy in end-stage renal disease (ESRD) patients. Functional iron deficiency occurs with serum ferritin >500 ng/ml and/or transferrin saturation (TSAT) of 20 to 30%. This study examines the effects of a maintenance intravenous iron dextran (ivID) protocol that increased TSAT in ESRD hemodialysis patients from conventional levels of 20 to 30% (control group) to those of 30 to 50% (study group) for a period of 6 mo. Forty-two patients receiving chronic hemodialysis completed a 16- to 20-wk run-in period, during which maintenance ivID and rhEPO were administered in amounts to achieve average TSAT of 20 to 30% and baseline levels of hemoglobin of 9.5 to 12.0 g/dl. After the run-in period, 19 patients randomized to the control group received ivID doses of 25 to 150 mg/wk for 6 mo. Twenty-three patients randomized to the study group received four to six loading doses of ivID, 100 mg each, over a 2-wk period to achieve a TSAT >30% followed by 25 to 150 mg weekly to maintain TSAT between 30 and 50% for 6 mo. Both regimens were effective in maintaining targeted hemoglobin levels. Fifteen patients in the control group and 17 patients in the study group finished the study in which the primary outcome parameter by intention to treat analysis was the rhEPO dose needed to maintain prestudy hemoglobin levels. Maintenance ivID requirements in the study group increased from 176 to 501 mg/mo and were associated with a progressive increase in serum ferritin to 658 ng/ml. Epoetin dose requirements for the study group decreased by the third month and remained 40% lower than for the control group, resulting in an overall cost savings in managing the anemia. Secondary indicators of iron-deficient erythropoiesis were also assessed. Zinc protoporphyrin did not change in either group. Reticulocyte hemoglobin content increased only in the study group from 28.5 to 30.1 pg. It is concluded that maintenance of TSAT between 30 and 50% reduces rhEPO requirements significantly over a 6-mo period.