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Pulmonary Hypertension in Sickle Cell Anemia

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121. Hematopoietic Stem Cell Transplant for Sickle Cell Disease

donor cells (graft) after the patient gets a Hematopoietic (blood) stem cell transplant. Condition or disease Intervention/treatment Phase Sickle Cell Disease Sickle Cell Anemia SCD Drug: Fludarabine Procedure: Hematopoietic Stem Cell Transplant (HSCT) Phase 1 Phase 2 Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Estimated Enrollment : 25 participants Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment (...) Center Information provided by (Responsible Party): Case Comprehensive Cancer Center Study Details Study Description Go to Brief Summary: This is a phase I/II study of patients with sickle cell disease. It aims to find out if people with sickle cell disease can be cured by changing their immune system before they have blood stem cell transplants. Doctors will give patients a new drug (fludarabine) to see if this drug changes patients immune system and reduces the patient's cells (host) from rejecting

2014 Clinical Trials

122. Assessment of Tolerance of Mobilizing Peripheral Hematopoietic Stem Cells by Plerixafor in Sickle Cell Patients

compromise his/her ability to participate in the study Current Pregnancy or breastfeeding For women of childbearing potential no use effective contraception throughout the whole treatment duration Major dysfunction of : Liver : transaminases superior or egal at 3 times more than normal Heart with alteration of the left ventricular ejection fraction (LVEF) Pulmonary High blood pressure confirmed by catheterization Renal with calculated clearance with of creatinine < 30% Severe iron overload with abnormal (...) antibodies). Presence of sickle cell cardiomyopathy documented by Doppler echocardiography. Informed and signed consent Exclusion Criteria: Patient who to his knowledge and that of the investigator, is unable to follow the visits required by the protocol Any form of disorder that, according to the investigator, may compromise the ability of the patient to give an informed written consent and / or to conform to all required procedures of the study. Positive serology for HIV-1/2, HTLV-1/2, syphilis, HCV

2014 Clinical Trials

123. KDIGO Clinical Practice Guideline for Anemia in Chronic Kidney Disease

of the anemia (Not Graded): K Complete blood count (CBC), which should include Hb concentration, red cell indices, white blood cell count and differential, and platelet count K Absolute reticulocyte count K Serum ferritin level K Serum transferrin saturation (TSAT) K Serum vitamin B 12 and folate levels Chapter 2: Use of iron to treat anemia in CKD TREATMENT WITH IRON AGENTS 2.1.1: When prescribing iron therapy, balance the potential bene?ts of avoiding or minimizing blood transfusions, ESA therapy (...) be con?rmed to be below the threshold values for diagnosis of anemia prior to initiating a diagnostic work up. Investigation of anemia 1.3: In patients with CKD and anemia (regardless of age and CKD stage), include the following tests in initial evaluation of the anemia (Not Graded): K Complete blood count (CBC), which should include Hb concentration, red cell indices, white blood cell count and differential, and platelet count K Absolute reticulocyte count K Serum ferritin level K Serum transferrin

2012 National Kidney Foundation

124. Efficacy and Safety Study to Evaluate MT-6548 in Non-dialysis Subjects With Anemia Associated With Chronic Kidney Disease in Japan

period less than 1.5 g/dL Serum ferritin ≥ 100 ng/mL, or TSAT ≥20% during the screening period Folate and vitamin B12 ≥ lower limit of normal during the screening period Exclusion Criteria: Anemia due to a main cause other than CKD: sickle cell disease, myelodysplastic syndrome, bone marrow fibrosis, hematologic malignancy, hemolytic anemia, thalassemia, or pure red cell aplasia Active bleeding or recent blood loss within 8 weeks prior to the screening period RBC transfusion within 8 weeks prior (...) to the screening period Received testosterone enanthate or mepitiostane within 8 weeks prior to the screening period AST, ALT, or total bilirubin >2.5 x upper limit of normal during the screening period Uncontrolled hypertension (diastolic blood pressure >110 mm Hg or systolic blood pressure >180 mm Hg) during the screening period and Day 1 Ophthalmic examinations during the screening period correspond to either of the following criteria; No available fundal findings Findings indicating the presence of active

2017 Clinical Trials

125. Efficacy and Safety Study to Evaluate MT-6548 in Peritoneal Dialysis Subjects With Anemia Associated With Chronic Kidney Disease in Japan

less than 1.5 g/dL Serum ferritin ≥ 100 ng/mL, or TSAT ≥20% during the screening period Folate and vitamin B12 ≥ lower limit of normal during the screening period Exclusion Criteria: Anemia due to a main cause other than CKD: sickle cell disease, myelodysplastic syndrome, bone marrow fibrosis, hematologic malignancy, hemolytic anemia, thalassemia, or pure red cell aplasia Active bleeding or recent blood loss within 8 weeks prior to the screening period RBC transfusion within 8 weeks prior (...) to the screening period Received testosterone enanthate or mepitiostane within 8 weeks prior to the screening period Peritonitis within 4 weeks prior to the screening period AST, ALT, or total bilirubin >2.5 x upper limit of normal during the screening period Uncontrolled hypertension (diastolic blood pressure >110 mm Hg or systolic blood pressure >180 mm Hg) during the screening period and Day 1 Ophthalmic examinations during the screening period correspond to either of the following criteria; No available

2017 Clinical Trials

126. Pulmonary hypertension diagnosed by right heart catheterization in sickle cell disease. Full Text available with Trip Pro

Pulmonary hypertension diagnosed by right heart catheterization in sickle cell disease. Recent studies have recognised the importance of pulmonary hypertension (PH) in sickle cell disease (SCD). The aim of this study was to determine the prevalence and prognostic impact of PH and its features in patients with SCD. 80 patients with SCD underwent baseline clinical evaluation, laboratory testing, 6-min walk tests (6MWTs) and echocardiography. Patients with a peak tricuspid regurgitant jet velocity (...) (TRV) of ≥ 2.5 m·s(-1) were further evaluated through right heart catheterisation (RHC) to assure the diagnosis of PH. Our study evidenced a 40% prevalence of patients with elevated TRV at echocardiography. RHC (performed in 25 out of 32 patients) confirmed PH in 10% (95% CI 3.4-16.5%) of all patients, with a prevalence of post-capillary PH of 6.25% (95% CI 0.95-11.55%) and pre-capillary PH of 3.75% (95% CI -0.4-7.9%). Patients with PH were older, had worse performance in 6MWTs, and more pronounced

2011 European Respiratory Journal

127. Novel Cardiac Magnetic Resonance Imaging to Define a Unique Restrictive Cardiomyopathy in Sickle Cell Disease

: Children's Hospital Medical Center, Cincinnati ClinicalTrials.gov Identifier: Other Study ID Numbers: 2012-4851 First Posted: April 8, 2015 Last Update Posted: December 5, 2017 Last Verified: December 2017 Keywords provided by Children's Hospital Medical Center, Cincinnati: Sickle Cell Disease (SCD) Cardiac Magnetic Resonance Imaging (CMR) Cardiomyopathy Pulmonary Hypertension Additional relevant MeSH terms: Layout table for MeSH terms Cardiomyopathies Anemia, Sickle Cell Cardiomyopathy, Restrictive (...) the most common causes of death in SCD, especially in adolescents and adults. Patients with SCD have features of both an anemia-related, high cardiac output state and a restrictive cardiomyopathy (RCM). The investigators propose that this unique RCM is an overlooked and understudied complication of SCD. RCM could explain the modest increases in pulmonary artery pressure in patients with SCD, as measured by cardiac catheterization or estimated by tricuspid regurgitant jet velocity (TRJV), which has

2014 Clinical Trials

128. Gene Transfer for Patients With Sickle Cell Disease

Collaborator: Doris Duke Charitable Foundation Information provided by (Responsible Party): Children's Hospital Medical Center, Cincinnati Study Details Study Description Go to Brief Summary: The purpose of this study is to determine whether transfer of a fetal hemoglobin gene using a lentivirus vector (gene transfer) into human blood making cells is safe and feasible in patients with sickle cell disease. Condition or disease Intervention/treatment Phase Sickle Cell Disease Sickle Cell Anemia Genetic: Gene (...) transfer Phase 1 Phase 2 Detailed Description: The purpose is also to determine if this kind of gene transfer works in getting the body to make red blood cells that don't sickle in patients with sickle cell disease. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Estimated Enrollment : 10 participants Intervention Model: Single Group Assignment Intervention Model Description: Gamma Globin Lentivirus Vector Masking: None (Open Label) Primary Purpose

2014 Clinical Trials

129. Allograft for Sickle Cell Disease and Thalassemia

and +100 the chimeric status of patients will be assessed by microsatellite analysis of the peripheral blood. More frequent monitoring may be required. Sickle cell patients with pulmonary hypertension will meet with a Pulmonary Medicine Consult to determine appropriate management prior to SCT. Patients with fever or suspected minor infection should await resolution of symptoms before starting the conditioning regimen. Iron chelation must be discontinued > 48 hours before initiating the conditioning (...) with severe congenital anemias. The patient cohort to be studied: Those patients with severe sickle cell disease and thalassemia who have risk factors for high mortality and morbidity related to their disease Transplant Conditioning Regimen - Immunosuppression without myeloablation: Patients will receive conditioning sufficient to allow donor lympho-hematopoietic engraftment without complete marrow ablation. If the graft is rejected, the patient will reconstitute autologous marrow function. We will use

2014 Clinical Trials

130. A Study Evaluating the Efficacy and Safety of LentiGlobin BB305 Drug Product in Beta-Thalassemia Major and Sickle Cell Disease

and expression by evaluation [ Time Frame: 1-24 months post-transplant ] Average vector copy number (VCN) in cell populations from peripheral blood and bone marrow containing the integrated LentiGlobin BB305 lentiviral vector. Efficacy [ Time Frame: 1-24 months post-transplant ] For all subjects, red blood cell (RBC) transfusion requirements (measured in milliliters [mL] per kilogram [kg]) per month and per year post transplant Efficacy [ Time Frame: 1-24 months post-transplant ] For sickle cell disease (SCD (...) . For general information, Layout table for eligibility information Ages Eligible for Study: 5 Years to 35 Years (Child, Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria Inclusion Criteria: Be between 5 and 35 years of age, inclusive. Have severe sickle cell disease (SCD) or transfusion dependent beta-thalassemia major, regardless of the genotype with the diagnosis confirmed by Hb studies. Transfusion dependence is defined as requiring at least 100 mL/kg/year of packed red blood

2014 Clinical Trials

131. Pediatrics, Sickle Cell Disease (Treatment)

hemolytic markers, iron overload, and a history of priapism. Even modestly increased pulmonary artery pressures are associated with severe reduction in exercise capacity, as assessed by both the 6-minute walk and cardiopulmonary exercise testing, and herald a poor prognosis. Both pulmonary hypertension and cardiac sequelae, such as diastolic dysfunction, have been associated with accelerated mortality in the sickle cell disease population. For symptomatic patients, hydroxyurea and chronic transfusion (...) : Management of vaso-occlusive crisis Management of chronic pain syndromes Management of chronic hemolytic anemia Prevention and treatment of infections Management of the complications and the various organ damage syndromes associated with the disease Prevention of stroke Detection and treatment of pulmonary hypertension An expert panel has released evidence-based guidelines for the treatment of SCD, including a strong recommendation that hydroxyurea and long-term, periodic blood transfusions should

2014 eMedicine Emergency Medicine

132. Pediatrics, Sickle Cell Disease (Diagnosis)

(ABPM) to identify these conditions in young patients. [ ] In the study, 17 patients (43.6%) had ambulatory hypertension, whereas 4 (10.3%) had hypertension on the basis of their clinic blood pressure. Twenty-three patients (59%) had impaired systolic blood pressure dipping, 7 (18%) had impaired diastolic blood pressure dipping, and 5 (13%) had reversed dipping. [ ] Imaging studies Imaging studies that aid in the diagnosis of sickle cell anemia in patients in whom the disease is suggested clinically (...) P, Godeau B, et al. Acute kidney injury in sickle patients with painful crisis or acute chest syndrome and its relation to pulmonary hypertension. Nephrol Dial Transplant . 2010 Aug. 25(8):2524-9. . Scheinman JI. In: Holliday M, Barratt TM, Avner ED (Eds.). Sickle cell nephropathy . Baltimore: Williams and Wilkins; 1994. Pediatric Nephrology: 908. Nissenson AR, Port FK. Outcome of end-stage renal disease in patients with rare causes of renal failure. I. Inherited and metabolic disorders. Q J Med

2014 eMedicine Emergency Medicine

133. Pediatrics, Sickle Cell Disease (Follow-up)

hemolytic markers, iron overload, and a history of priapism. Even modestly increased pulmonary artery pressures are associated with severe reduction in exercise capacity, as assessed by both the 6-minute walk and cardiopulmonary exercise testing, and herald a poor prognosis. Both pulmonary hypertension and cardiac sequelae, such as diastolic dysfunction, have been associated with accelerated mortality in the sickle cell disease population. For symptomatic patients, hydroxyurea and chronic transfusion (...) : Management of vaso-occlusive crisis Management of chronic pain syndromes Management of chronic hemolytic anemia Prevention and treatment of infections Management of the complications and the various organ damage syndromes associated with the disease Prevention of stroke Detection and treatment of pulmonary hypertension An expert panel has released evidence-based guidelines for the treatment of SCD, including a strong recommendation that hydroxyurea and long-term, periodic blood transfusions should

2014 eMedicine Emergency Medicine

134. Pediatrics, Sickle Cell Disease (Overview)

(ABPM) to identify these conditions in young patients. [ ] In the study, 17 patients (43.6%) had ambulatory hypertension, whereas 4 (10.3%) had hypertension on the basis of their clinic blood pressure. Twenty-three patients (59%) had impaired systolic blood pressure dipping, 7 (18%) had impaired diastolic blood pressure dipping, and 5 (13%) had reversed dipping. [ ] Imaging studies Imaging studies that aid in the diagnosis of sickle cell anemia in patients in whom the disease is suggested clinically (...) P, Godeau B, et al. Acute kidney injury in sickle patients with painful crisis or acute chest syndrome and its relation to pulmonary hypertension. Nephrol Dial Transplant . 2010 Aug. 25(8):2524-9. . Scheinman JI. In: Holliday M, Barratt TM, Avner ED (Eds.). Sickle cell nephropathy . Baltimore: Williams and Wilkins; 1994. Pediatric Nephrology: 908. Nissenson AR, Port FK. Outcome of end-stage renal disease in patients with rare causes of renal failure. I. Inherited and metabolic disorders. Q J Med

2014 eMedicine Emergency Medicine

135. Is Resistance Futile?. Hemodynamics in Sickle Cell Disease Full Text available with Trip Pro

, Sickle Cell complications Female Humans Hypertension, Pulmonary etiology Male 2013 4 17 6 0 2013 4 17 6 0 2013 6 12 6 0 ppublish 23586378 10.1164/rccm.201303-0410ED PMC3707370 Haematologica. 2013 Mar;98(3):464-72 22983573 Eur Respir J. 2012 Jan;39(1):112-8 21778170 Am J Respir Crit Care Med. 2013 Apr 15;187(8):840-7 23348978 Blood. 2003 Feb 15;101(4):1257-61 12393669 N Engl J Med. 2004 Feb 26;350(9):886-95 14985486 Liver Transpl. 2005 Sep;11(9):1107-11 16123953 Br J Haematol. 2006 Jul;134(1):109-15 (...) Is Resistance Futile?. Hemodynamics in Sickle Cell Disease 23586378 2013 06 11 2018 12 02 1535-4970 187 8 2013 Apr 15 American journal of respiratory and critical care medicine Am. J. Respir. Crit. Care Med. Is resistance futile?: Hemodynamics in sickle cell disease. 790-2 10.1164/rccm.201303-0410ED Smith Kerri Akaya KA Kawut Steven M SM eng Editorial Comment United States Am J Respir Crit Care Med 9421642 1073-449X AIM IM Am J Respir Crit Care Med. 2013 Apr 15;187(8):840-7 23348978 Anemia

2013 American Journal of Respiratory and Critical Care Medicine

136. Abciximab (ReoPro) as a Therapeutic Intervention for Sickle Cell Vaso-Occlusive Pain Crisis

., Professor of Pediatrics, St. Louis University ClinicalTrials.gov Identifier: Other Study ID Numbers: SLU 23331 First Posted: August 30, 2013 Last Update Posted: March 26, 2015 Last Verified: March 2015 Keywords provided by William Ferguson M.D., St. Louis University: Sickle Cell Pain Crisis Abciximab Integrins Cell Adhesion Molecules Additional relevant MeSH terms: Layout table for MeSH terms Anemia, Sickle Cell Anemia, Hemolytic, Congenital Anemia, Hemolytic Anemia Hematologic Diseases (...) Abciximab (ReoPro) as a Therapeutic Intervention for Sickle Cell Vaso-Occlusive Pain Crisis Abciximab (ReoPro) as a Therapeutic Intervention for Sickle Cell Vaso-Occlusive Pain Crisis - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more

2013 Clinical Trials

137. Study of SANGUINATEâ„¢ Versus Hydroxyurea in Sickle Cell Disease (SCD) Patients

for Study: 19 Years and older (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria Inclusion Criteria: Patients with Homozygous (HbSS) Sickle Cell Anemia; Hb levels: >6g/dL - <10g/dL; Age : >18 years old; Frequency of ER hospitalizations < 6x/yr for SCD pain events documented "medical history". Exclusion Criteria: Patients, who are on chronic transfusion program, defined as regular transfusions every 2-8 weeks; Allergic to Hydroxyurea; History of clinical (...) significant disease, as determined by the Investigator; History of allergy or major allergic reaction considered to be clinically significant by the Investigator; Screening assessments considered to be abnormal by the Investigator; Patient has sever pulmonary hypertension (index >3 meters per sec); Donated blood within 60 days of screening or otherwise experienced blood loss of >250 mL within the same period; Intending to begin new concomitant drug therapy or over-the-counter medication anytime from

2013 Clinical Trials

138. Vaporized Cannabis for Chronic Pain Associated With Sickle Cell Disease

Heart, Lung, and Blood Institute (NHLBI) University of Minnesota - Clinical and Translational Science Institute Information provided by (Responsible Party): University of California, San Francisco Study Details Study Description Go to Brief Summary: Our primary objective is to assess whether inhaling vaporized cannabis ameliorates chronic pain in patients with sickle cell disease (SCD). As these patients will all be on chronic opioid analgesics, the investigators will also assess the possible (...) Inclusion Criteria: Sickle cell disease, including sickle cell anemia (SS), sickle-hemoglobin C disease (SC), and sickle beta thalassemia disease (Sb). Ongoing opioid analgesic therapy for chronic sickle cell disease-associated pain. Subjects must be on a stable dose of analgesic medication (opioid or other) for at least 2 weeks before enrollment. All men and women in this study must agree to use adequate birth control during this study. Acceptable barrier birth control methods are a male condom, female

2013 Clinical Trials

139. Hemoglobin sickle cell disease in Brazil Full Text available with Trip Pro

Hemoglobin sickle cell disease in Brazil 23277594 2014 04 14 2018 12 02 1592-8721 98 1 2013 Jan Haematologica Haematologica Hemoglobin sickle cell disease in Brazil. e9 10.3324/haematol.2012.076828 Cabañas-Pedro Ana Carolina AC Braga Josefina A P JA Camilo-Araújo Roberta F RF Silva Ana I M AI Vicari Perla P Figueiredo Maria M eng Letter Comment Italy Haematologica 0417435 0390-6078 IM Haematologica. 2012 Aug;97(8):1136-41 22315500 Anemia, Sickle Cell complications Female Humans Hypertension (...) , Pulmonary etiology Kidney Diseases etiology Male 2013 1 2 6 0 2013 1 2 6 0 2014 4 15 6 0 ppublish 23277594 haematol.2012.076828 10.3324/haematol.2012.076828 PMC3533669 Hum Hered. 1983;33(2):125-9 6862455 Lancet. 2000 Jul 8;356(9224):168-9 10963278 Hemoglobin. 2001 Aug;25(3):297-303 11570722 Clin Lab Haematol. 2004 Feb;26(1):15-9 14738432 Haematologica. 2012 Aug;97(8):1136-41 22315500 Hum Hered. 1994 Nov-Dec;44(6):322-7 7860085 Am J Hematol. 1996 Oct;53(2):72-6 8892730 Cad Saude Publica. 2005 Jul-Aug;21

2013 Haematologica

140. Childhood Hematopoietic Cell Transplantation (PDQ®): Health Professional Version

Risk of graft rejection Low Low–moderate Moderate–high Moderate–high Moderate–high Time to immune reconstitution a Rapid (6–12 mo) Moderate (6–18 mo) Slow (6–24 mo) Slow (6–24 mo) Slow (9–24 mo) b Risk of acute GVHD Moderate Moderate Moderate Low Low Risk of chronic GVHD High Moderate Low Low Low BM = bone marrow; EBV-LPD = Epstein-Barr virus–associated lymphoproliferative disorder; GVHD = graft-versus-host disease; HCT = hematopoietic cell transplantation; PBSCs = peripheral blood stem cells (...) A, von Stackelberg A, Schrappe M, et al.: Allogeneic hematopoietic SCT in children with ALL: current concepts of ongoing prospective SCT trials. Bone Marrow Transplant 41 (Suppl 2): S71-4, 2008. [ ] Bertaina A, Merli P, Rutella S, et al.: HLA-haploidentical stem cell transplantation after removal of αβ+ T and B cells in children with nonmalignant disorders. Blood 124 (5): 822-6, 2014. [ ] Handgretinger R, Chen X, Pfeiffer M, et al.: Feasibility and outcome of reduced-intensity conditioning

2018 PDQ - NCI's Comprehensive Cancer Database

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