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A Phase 2 Randomized Controlled Trial of Single-Agent Hydroxyurea Versus Thalidomide Among Adult Transfusion Dependent β Thalassemia Patients
Bhattacharjee U, Khadwal A, Shafiq N, Lad D, Sharma P, Das R, Shukla P, Jain A, Prakash G, Malhotra P
Indian journal of hematology & blood transfusion : an official journal of Indian Society of Hematology and Blood Transfusion. 2023;:1-10
Abstract
Hydroxyurea and low dose thalidomide are low-cost, easily accessible Hb F inducing agents that have been found to decrease transfusion dependency among transfusion-dependent thalassemia patients. However, these drugs have not much been explored in a randomized controlled setting. The objective of this study was to determine the efficacy and safety of hydroxyurea and low dose thalidomide in adult transfusion dependent β thalassemia. A total of 39 transfusion dependent β thalassemia patients were randomized into three arms: Arm A (Hydroxyurea 500 mg/day), Arm B (thalidomide 50 mg/day), and Control Arm. The primary outcome was rise in haemoglobin at 24-weeks from the baseline levels. The mean age of the cohort was 26.9 ± 4.7 years. Total 13 patients (33.3%) were splenectomised. The mean rise of haemoglobin at the end of 24 weeks was 0.18 ± 0.645 g/dl, 0.56 ± 1.343 g/dl, and - 0.31 ± 0.942 g/dl in Arm A, Arm B and control arm, respectively, p = 0.127. The mean volume of blood transfused per unit body weight in 24 weeks was significantly less in the thalidomide arm compared with the control arm (p = 0.035). Abdominal pain (Grade 1-2, 23.1%) and pruritus (Grade 1, 15.4%) were the main adverse events in hydroxyurea arm, whereas somnolence was the main side effect noted in the thalidomide arm (Grade 1-2, 78.3%). Single agent hydroxyurea or thalidomide is ineffective in increasing haemoglobin and decreasing transfusion burden among majority of the adult transfusion dependent thalassemia patients. SUPPLEMENTARY INFORMATION The online version contains supplementary material available at 10.1007/s12288-022-01620-3.
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Admission CT radiomic signatures outperform hematoma volume in predicting baseline clinical severity and functional outcome in the ATACH-2 trial intracerebral hemorrhage population
Haider SP, Qureshi AI, Jain A, Tharmaseelan H, Berson ER, Zeevi T, Majidi S, Filippi CG, Iseke S, Gross M, et al
European journal of neurology. 2021
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Abstract
BACKGROUND Radiomics provides a framework for automated extraction of high-dimensional feature sets from medical images. We aimed to determine radiomics signature correlates of admission clinical severity and medium-term outcome from intracerebral hemorrhage (ICH) lesions on baseline head CTs. METHODS We used the ATACH-2 (Antihypertensive-Treatment-of-Acute-Cerebral-Hemorrhage-II) trial dataset. Patients included in this analysis (n=895) were randomly allocated to discovery (n=448) and independent validation (n=447) cohorts. We extracted 1130 radiomics features from hematoma lesions on baseline non-contrast head CTs and generated radiomics signatures associated with admission Glasgow Coma Scale (GCS), admission National Institutes of Health Stroke Scale (NIHSS), and 3-month modified Rankin Scale (mRS) scores. Spearman's correlation between radiomics signatures and corresponding target variables was compared with hematoma volume. RESULTS In the discovery cohort, radiomics signatures - compared to ICH volume - had significantly stronger association with admission GCS (0.47 vs 0.44, p=0.008), admission NIHSS (0.69 vs 0.57, p<0.001), and 3-month mRS scores (0.44 vs 0.32, p<0.001). Similarly, in independent validation, radiomics signatures - compared to ICH volume - had significantly stronger association with admission GCS (0.43 vs 0.41, p=0.02), NIHSS (0.64 vs 0.56, p<0.001), and 3-month mRS scores (0.43 vs 0.33, p<0.001). In multiple regression analysis adjusted for known predictors of ICH outcome, the radiomics signature was an independent predictor of 3-month mRS in both cohorts. CONCLUSIONS Limited by the enrollment criteria of the ATACH-2 trial, we showed that radiomics features quantifying hematoma texture, density and shape on baseline CT can provide imaging correlates for clinical presentation and medium-term outcome.
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Comparison of efficacy of packed red blood cell transfusion based on its hemoglobin content versus the standard transfusion practice in thalassemia major patients (HEMOCON study)
Raja A, Jain A, Marwaha N, Trehan A
Transfusion and apheresis science : official journal of the World Apheresis Association : official journal of the European Society for Haemapheresis. 2020;:102736
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Abstract
The hemoglobin (Hb) content of packed red blood cell (PRBC) units is heterogenous. The efficacy of a transfusion episode can be assessed if the Hb content of the PRBC is known and the patient's post-transfusion Hb increment is also determined. This prospective study compared the efficacy of PRBC transfusion based on its Hb content versus the standard transfusion practice. A total of 160 thalassemia major patients were enrolled and randomly divided into two equal groups: Group I (n = 80) - they received ABO/RhD identical PRBCs after determining its Hb content (≥50 g); and Group II (n = 80) - they received randomly selected ABO/RhD identical PRBCs. Hb estimation and a direct antiglobulin test were performed on the post-transfusion sample (1 h). The mean Hb content of the PRBC units was significantly higher (p = 0.000) in group I (67.86 +/- 8.07 g; range: 50.80-92.13 g) than group II (60.92 +/- 8.29 g; range: 40.86-86.76 g). The mean Hb increment was also significantly higher in group I patients (p = 0.04). In both the groups, there was a significant negative correlation between Hb increment and weight, age, body surface area and blood volume (p < 0.05). There was a significant positive correlation between Hb increment and Hb dose adjusted for body surface area as well as blood volume (p < 0.05). PRBC transfusion was more efficacious in patients who were transfused with PRBCs having a Hb content ≥50 g as compared to those who received randomly selected PRBCs.
PICO Summary
Population
Thalassemia major patients (n=160).
Intervention
ABO/RhD identical packed red blood cell (PRBCs) after determining its Hb content (>/=50 g) group I, (n = 80).
Comparison
Randomly selected ABO/RhD identical PRBCs group II ,(n = 80).
Outcome
The mean Hb content of the PRBC units was significantly higher in group I (67.86 +/- 8.07 g; range: 50.80-92.13 g) than group II (60.92 +/- 8.29 g; range: 40.86-86.76 g). The mean Hb increment was also significantly higher in group I patients. In both the groups, there was a significant negative correlation between Hb increment and weight, age, body surface area and blood volume. There was a significant positive correlation between Hb increment and Hb dose adjusted for body surface area as well as blood volume. PRBC transfusion was more efficacious in patients who were transfused with PRBCs having a Hb content >/=50 g as compared to those who received randomly selected PRBCs.
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Combining Platelet-Rich Plasma Instillation With Core Decompression Improves Functional Outcome and Delays Progression in Early-Stage Avascular Necrosis of Femoral Head: a 4.5- to 6-Year Prospective Randomized Comparative Study
Aggarwal AK, Poornalingam K, Jain A, Prakash M
J Arthroplasty. 2020
Abstract
BACKGROUND Avascular necrosis of femoral head is a debilitating disease frequently progressing to femoral head collapse and joint destruction. The efficacy of core decompression (CD) remains controversial. METHODS About 40 consecutive age-matched and gender-matched patients (53 hips) were randomized into 2 groups by computer-generated algorithm table in a prospective randomized double-blinded comparative study. Group A (platelet-rich plasma [PRP] with CD) included 19 patients (25 hips), and group B (CD only) included 21 patients (28 hips). Postoperative Harris Hip Score and magnetic resonance imaging to quantify the necrotic area by using modified Kerboul angle were done and evaluated. Mean follow-up was 64.3 months (range, 54-72) and 63.7 months (range, 56-72) in groups A and B, respectively. RESULTS There was statistically significant difference between PRP and control groups in pain score (P = .00), functional score (P = .02), and Harris Hip Score (P = .00) at final follow-up. There was no progression in stage 1 disease. Stage 2 disease showed 24% progression in group A and 43% progression in group B. The difference was statistically significant (P = .025). Survivorship from femoral head collapse, any procedure, and total hip arthroplasty was 84%/68% (P = .00), 76%/57% (P = .02), and 92%/78% (P = .01) in 2 groups, which was statistically significant. CONCLUSION PRP use after CD provides significant pain relief, better midterm functional outcome, retards the progression, and enhances the survivorship free from reoperation for hip arthroplasty and femoral head collapse in early stages of avascular necrosis of hip than CD alone.
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[Effectiveness of platelet rich plasma in pain management of osteoarthritis knee: Double blind, randomized comparative study]
Ghai B, Gupta V, Jain A, Goel N, Chouhan D, Batra YK
Revista brasileira de anestesiologia. 2019
Abstract
BACKGROUND Intra-articular injections of platelet-rich plasma to treat symptoms of knee osteoarthritis have been successfully used in young patients. However in most of these studies the control and test knees were present in different patients thus incorporating a large amount of bias in the results. Therefore, the present study was designed in which patients with bilateral osteoarthritis knee were included and platelet-rich plasma was administered in one knee and normal saline in another knee of same patient. METHODS 20 patients aged 30-65years with bilateral osteoarthritis knees (ASA class I and II) of either gender were included in the study. Patients were randomized to receive platelet-rich plasma and normal saline in one of the two knees. The primary outcome was VAS and WOMAC score at 6months after procedure. The secondary outcome included changes in joint stiffness, physical function, any adverse effects noted during the course of study. RESULTS The baseline VAS score in platelet-rich plasma knee was 8.4 +/- 0.88 which improved significantly to 4.85 +/- 2.48 (p < 0.001) at 6months as compared to normal saline knee (p = 0.017). The WOMAC pain score also improved from baseline (14.5 +/- 1.3) to over 6month 7.00 +/- 4.24 (p < 0.001) in platelet-rich plasma knee while in the normal saline knee, no significant change occurred from baseline to six months (10.2 +/- 1.2 to 10.05 +/- 1.23). There was also significant decrease in stiffness and improvement of physical activity in the platelet-rich plasma knee as compared to normal saline knee. CONCLUSION The present study showed significant decrease in pain and stiffness and improvement of physical functions of knee joint with intra-articular platelet-rich plasma injection as compared to normal saline.
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Effect of alternative positions of neonates prior to delayed cord clamping on placental transfusion: A randomized control trial
Jain R, Jain A, Devgan V, Sekhar J
The Journal of Maternal-Fetal & Neonatal Medicine : the Official Journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians. 2018;:1-141.
Abstract
OBJECTIVE To determine the effect of alternative positions (relative to placenta) of normal term neonates, prior to the recommended delayed cord clamping, on placental transfusion and short-term neonatal outcome. METHODS Normal term neonates born vaginally were randomly assigned to be placed either on mother's abdomen (Group AL, n = 97) or 20 cm below the introitus (Group BL, n = 102) for 90 seconds after delivery. Subsequently the cord was clamped. Outcome measures were anthropometry, hematological profile including ferritin at birth and at 3-4 months; and adverse effects, polycythemia and jaundice. RESULTS Both groups had comparable outcome measures at birth. At 3-4 months, mean hemoglobin (AL: 12.0 +/- 0.9 g/dl, BL: 12.3 +/- 1.1 g/dl; p = 0.02, 95% CI 0.03-0.58) and hematocrit (AL: 36.1 +/- 2.7%, BL: 37 +/- 3.2%; p = 0.01, 95% CI 0.1-1.75) were significantly higher in BL group. Anthropometry, serum ferritin, incidence of anemia and iron deficiency at 3-4 months were similar in both groups. There was no significant difference in polycythemia, jaundice requiring phototherapy or respiratory distress between the two groups. CONCLUSIONS Placing the baby below the placenta resulted in a statistically significant increase in hemoglobin and hematocrit at 3-4 months without any adverse outcomes. However, this meager quantum of increase did not translate into reduction of risk of anemia or improvement in iron stores. Registration number: CTRI/2013/06/003726.
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Comparative evaluation of platelet rich fibrin and dehydrated amniotic membrane for the treatment of gingival recession - a clinical study
Jain A, Jaiswal GR, Kumathalli K, Kumar R, Singh A, Sarwan A
Journal of Clinical and Diagnostic Research : Jcdr. 2017;11((8)):ZC24-ZC28.
Abstract
INTRODUCTION The main objective of any therapeutic intervention aimed at root coverage is to restore the tissue margin to the cemento-enamel junction and to regenerate the lost periodontium. AIM: To compare the effectiveness of Platelet Rich Fibrin (PRF) and Amniotic Membrane (AM) in the treatment of gingival recession by Coronally Advanced Flap (CAF) Technique. MATERIALS AND METHODS Thirty systemically healthy patients who met inclusion-exclusion criteria were selected. After Phase-I therapy, patients were randomly allocated to one of the groups; PRF (Group-A) and Amnion Group (Group-B). Clinical parameters like Plaque Index (PI), Recession Depth (RD) and Width of Keratinized Gingiva (WKG) were measured on the baseline day, three months and six months postoperatively. Mann-Whitney test and Wilcoxon signed ranks test were applied for intergroup and intragroup comparisons respectively. RESULTS Intergroup comparison between platelet rich fibrin and amniotic membrane showed statistically insignificant difference in the recession depth and width of keratinized gingiva at three and six months postoperatively. CONCLUSION Both the membranes were equally effective in terms of recession coverage and increase in width of keratinized gingiva.
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Factors affecting the quality of cryoprecipitate
Subramaniyan R, Marwaha N, Jain A, Ahluwalia J
Asian Journal of Transfusion Science. 2017;11((1)):33-39.
Abstract
BACKGROUND Many variables affect the quality of cryoprecipitate (CRYO). We investigated the effect of freezing techniques and ABO blood groups on the quality of CRYO with respect to factor VIII C and fibrinogen levels. MATERIALS AND METHODS Ninety-six whole blood units each collected from in-house (Group I) and blood donation camps outside the hospital premises (Group II) were processed for CRYO preparation. Within each group, half the number of plasma units was frozen using blast freezer and another half using the conventional freezer. The CRYOs from blood groups A, B, and O were equally distributed, i.e. 32 within each of the Groups I and II. The fibrinogen and factor VIII C levels in CRYO were analyzed using single-stage clotting assay. RESULTS In Group I, the mean +/- standard deviation percentage recovery of factor VIII levels in CRYO prepared using the conventional freezer and blast freezer were 58.5% +/-16.2% and 66.7% +/-16.4%, respectively, and in Group II, it was 55.3% +/-17.6% and 70.4% +/-13.4%, respectively. Recovery of factor VIII was higher in CRYO prepared using blast freezer than that of CRYO prepared using conventional freezer (P < 0.000). In Group II, CRYOs prepared using blast freezer had higher percent recovery of fibrinogen than that of Group I. In both the groups, the mean factor VIII levels in blood group A were higher than that of factor VIII levels in the blood group O CRYO. CONCLUSION The factor VIII recovery in CRYO improves significantly with higher baseline factor VIII C levels, blood group A donor, and rapid freezing using blast freezer. Rapid freezing also increases the fibrinogen yield.
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Double volume exchange transfusion in severe neonatal sepsis
Aradhya AS, Sundaram V, Kumar P, Ganapathy SM, Jain A, Rawat A
Indian Journal of Pediatrics. 2016;83((2)):107-13.
Abstract
OBJECTIVES To study the efficacy and safety of double volume exchange transfusion (DVET) in neonates>1000 g birth weight with severe sepsis. METHODS Eighty-three neonates weighing >1000 g with severe sepsis were randomly assigned to DVET or standard therapy (ST) group. Primary outcome was mortality by 14 d from enrollment. RESULTS A 21 % reduction in mortality, albeit non-significant, by 14 d from enrollment was observed in DVET group in comparison to ST group [RR: 0.79 (95 % C.I 0.45-1.3); p 0.4]. A similar trend in mortality reduction was observed with early mortality and mortality by discharge in DVET group. No difference was observed in normalization of dysfunctional organs by 14 d. Cardiovascular and hematological system benefitted the most, followed by renal dysfunction with DVET. A significant improvement in post DVET IgG, IgA, IgM, C3 and base deficit was observed. No serious adverse effects occurred following DVET. CONCLUSIONS In neonates >1000 g with severe sepsis, DVET was associated with a trend towards decrease in mortality by 14 d from enrollment. A significant improvement in immunoglobulin and complement C3 levels and acid base status were observed following DVET. DVET is a safe procedure in severely sick and septic neonates.
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Platelet rich fibrin combined with decalcified freeze-dried bone allograft for the treatment of human intrabony periodontal defects: a randomized split mouth clinical trail
Agarwal A, Gupta ND, Jain A
Acta Odontologica Scandinavica. 2016;74((1)):36-43.
Abstract
OBJECTIVE Polypeptide growth factors of platelet rich fibrin (PRF) have the potential to regenerate periodontal tissues. Osteoinductive property of demineralized freeze-dried bone allograft (DFDBA) has been successfully utilized in periodontal regeneration. The aim of the present randomized, split mouth, clinical trial was to determine the additive effects of PRF with a DFDBA in the treatment of human intrabony periodontal defects. MATERIALS AND METHODS Sixty interproximal infrabony defects in 30 healthy, non-smoker patients diagnosed with chronic periodontitis were randomly assigned to PRF/DFDBA group or the DFDBA/saline. Clinical [pocket depth (PD), clinical attachment level (CAL) and gingival recession (REC)] and radiographic (bone fill, defect resolution and alveolar crest resorption) measurements were made at baseline and at a 12-month evaluation. RESULTS Compared with baseline, 12-month results indicated that both treatment modalities resulted in significant changes in all clinical and radiographic parameters. However, the PRP/DFDBA group exhibited statistically significantly greater changes compared with the DFDBA/saline group in PD (4.15 +/- 0.84 vs 3.60 +/- 0.51 mm), CAL (3.73 +/- 0.74 vs 2.61 +/- 0.68 mm), REC (0.47 +/- 0.56 vs 1.00 +/- 0.61 mm), bone fill (3.50 +/- 0.67 vs 2.49 +/- 0.64 mm) and defect resolution (3.73 +/- 0.63 vs 2.75 +/- 0.57 mm). CONCLUSION Observations indicate that a combination of PRF and DFDBA is more effective than DFDBA with saline for the treatment of infrabony periodontal defects.