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Pulmonary Hypertension in Sickle Cell Anemia

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101. Oxygen Therapy and Pregnancy in Sickle Cell Disease

pregnancy ] Painful vaso-occlusive episodes in bones, acute chest syndrome, ischemic stroke, cardiomyopathy, pulmonary hypertension, splenic and hepatic sequestration, death of the mother Secondary Outcome Measures : Occurrence of at least one vaso-occlusive complication which last more than 24h [ Time Frame: 30 days postpartum ] Painful vaso-occlusive episodes in bones, acute chest syndrome, ischemic stroke, cardiomyopathy, pulmonary hypertension, splenic and hepatic sequestration, death of the mother (...) -regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: No Keywords provided by Assistance Publique - Hôpitaux de Paris: sickle cell disease oxygen therapy pregnancy pregnancy in sickle cell disease Additional relevant MeSH terms: Layout table for MeSH terms Anemia, Sickle Cell Anemia, Hemolytic, Congenital Anemia, Hemolytic Anemia Hematologic Diseases Hemoglobinopathies Genetic Diseases, Inborn

2016 Clinical Trials

102. Bone Marrow Transplantation vs Standard of Care in Patients With Severe Sickle Cell Disease (BMT CTN 1503)

to their disease at a rate much higher than the general population. Therefore, the goal of the study is to establish that the difference in the proportion of patients surviving is not significantly more than 15% lower in the donor arm at 2-years after assignment to treatment arm. Secondary endpoints will compare changes in sickle cell disease related events (pulmonary hypertension, cerebrovascular events, renal function, avascular necrosis, leg ulcer) and functional outcomes [6-minute walk distance (6MWD (...) transplant. Participation in a clinical trial in which the patient received an investigational drug or device must be discontinued at enrollment. A history of substance abuse as defined by version IV of the Diagnostic & Statistical Manual of Mental Disorders (DSM IV). Demonstrated lack of compliance with prior medical care as determined by referring physician. Pregnant or breast feeding females. Inability to receive HCT due to alloimmunization, defined as the inability to receive packed red blood cell

2016 Clinical Trials

103. Elevated Transpulmonary Gradient and Cardiac Magnetic Resonance-Derived Right Ventricular Remodeling Predict Poor Outcomes in Sickle Cell Disease. Full Text available with Trip Pro

Elevated Transpulmonary Gradient and Cardiac Magnetic Resonance-Derived Right Ventricular Remodeling Predict Poor Outcomes in Sickle Cell Disease. 26589907 2017 01 04 2018 11 13 1592-8721 101 2 2016 Feb Haematologica Haematologica Elevated transpulmonary gradient and cardiac magnetic resonance-derived right ventricular remodeling predict poor outcomes in sickle cell disease. e40-3 10.3324/haematol.2015.125229 Nguyen Kim-Lien KL Cardiovascular and Pulmonary Branch, Lung and Blood Institute (...) PHS HHS United States 1ZIAHL006137 PHS HHS United States 1ZIAHL006011 PHS HHS United States 1ZIEHL006139 PHS HHS United States ZIA HL006011 HL NHLBI NIH HHS United States 1ZIAHL006012 PHS HHS United States Clinical Trial Letter Research Support, N.I.H., Extramural 2015 11 20 Italy Haematologica 0417435 0390-6078 IM Adult Anemia, Sickle Cell complications diagnosis mortality pathology Cardiac Catheterization Cardiac Output Cardiac Volume Female Heart Rate Humans Hypertension, Pulmonary

2015 Haematologica

104. Genetic diminution of circulating prothrombin ameliorates multi-organ pathologies in sickle cell disease mice. Full Text available with Trip Pro

Genetic diminution of circulating prothrombin ameliorates multi-organ pathologies in sickle cell disease mice. Sickle cell disease (SCD) results in vascular occlusions, chronic hemolytic anemia, and cumulative organ damage. A conspicuous feature of SCD is chronic inflammation and coagulation system activation. Thrombin (factor IIa [FIIa]) is both a central protease in hemostasis and a key modifier of inflammatory processes. To explore the hypothesis that reduced prothrombin (factor II [FII (...) end-organ damage (nephropathy, pulmonary hypertension, pulmonary inflammation, liver function, inflammatory infiltration, and microinfarctions). Notably, all of these benefits were achieved with a relatively modest 1.25-fold increase in prothrombin times, and in the absence of hemorrhagic complications. Taken together, these data establish that prothrombin is a powerful modifier of SCD-induced end-organ damage, and present a novel therapeutic target to ameliorate SCD pathologies. © 2015

2015 Blood

105. Ketamine Infusion for Acute Sickle Cell crisiS in the Emergency Department (KISS)

Responsible Party: Billy Sin, Primary investigator, The Brooklyn Hospital Center ClinicalTrials.gov Identifier: Other Study ID Numbers: 668842 First Posted: April 15, 2015 Last Update Posted: May 10, 2018 Last Verified: May 2018 Keywords provided by Billy Sin, The Brooklyn Hospital Center: ketamine pain sickle cell disorder Additional relevant MeSH terms: Layout table for MeSH terms Emergencies Anemia, Sickle Cell Disease Attributes Pathologic Processes Anemia, Hemolytic, Congenital Anemia, Hemolytic (...) Party): Billy Sin, The Brooklyn Hospital Center Study Details Study Description Go to Brief Summary: Pain associated with sickle cell disease is a common emergency department visit. It is also frequently associated with a high emergency department recidivism rate for pain control and admissions to the hospital. Opiates are considered the first line therapy for acute flares and to manage chronic pain. This often times leads to a stigma of being "opiate seekers" or "frequent fliers". With this study

2015 Clinical Trials

106. Added Value of Speckle Tracking in the Evaluation of Patients With Sickle Cell Disease

tracking, arterial pulmonary hypertension, left ventricular hypertrophy. Other: Biological parameters Hemoglobin levels, red cells, hematocrit, iron, ferritin Other: Clinical parameters Blood transfusion number, severity of the sickle cell disease damage, evolution duration of the sickness Healthy patients This is the control group for the sickle cell disease patients: each sickle cell disease patient will be matched with a healthy patient of the same sex and of similar age. Other: Cardiac echography (...) anemia, the haemosiderosis risk or, less frequently, to coronary vaso-occlusive damages. The hypervolemia in patients with sickle cell disease causes an overestimation of the ejected left ventricular fraction measured by echocardiography, this parameter being very dependent of the blood volume.It has already been shown that the left ventricular ejection fraction was normal in most patients with sickle cell disease, but that its evaluation by parameters independent from the blood volume showed

2015 Clinical Trials

107. The Role of Endothelin-1 in Sickle Cell Disease

2019 Keywords provided by Abdullah Kutlar, Augusta University: Sickle Cell Anemia Sickle Cell Thalassemia Sickle Beta Thalassemia Proteinuria Sickle nephropathy Additional relevant MeSH terms: Layout table for MeSH terms Anemia, Sickle Cell Anemia, Hemolytic, Congenital Anemia, Hemolytic Anemia Hematologic Diseases Hemoglobinopathies Genetic Diseases, Inborn Ambrisentan Antihypertensive Agents (...) , and Blood Institute (NHLBI) Information provided by (Responsible Party): Abdullah Kutlar, Augusta University Study Details Study Description Go to Brief Summary: The primary goal of the study is to determine the safety and tolerability of ambrisentan. It is also expected that ambrisentan will improve blood flow in the lungs, decrease inflammation, and reduce pain in sickle cell patients. An additional goal is to evaluate the use of select biomarkers in evaluating sickle nephropathy. Condition or disease

2015 Clinical Trials

108. A Multi-Center Study of Riociguat in Patients With Sickle Cell Diseases

: No Criteria Inclusion Criteria: Age ≥ 18 years Sickling disorder (HbSS, HbSC, HbSbeta-thalassemia, HbSD, HbSO-Arab documented by hemoglobin electrophoresis or HPLC fractionation) At least one of the following findings: a. Systolic blood pressure ≥ 130 mm Hg on at least two occasions at least 1 day apart (one of these may be by history), b. Macroalbuminuria as manifested by urine albumin to creatinine ratio > 300 mg/g, c. Tricuspid regurgitant velocity (TRV) > 2.9 m/sec measured by echocardiography d. NT (...) ) Patients on St. John's Wort If patients are taking antihypertensive drugs, hydroxyurea, or L-glutamine prior to enrollment, they are excluded until the dose level is stable for at least three months Systolic blood pressure <95 mm Hg at Screening Visit 1 or 2 or Week 0 before randomization Current enrollment in an investigational new drug trial. Patients are eligible for enrollment 30 days after the last dose of an investigational drug has been received Evidence of qualitative urine drug test

2015 Clinical Trials

109. Evaluation of a Training Program for Homozygous Sickle Cell Disease Patients

] Patients will be subjected to blood samplings Expression of erythrocytes membrane proteins (u.a.) [ Time Frame: 8 weeks ] Patients will be subjected to blood samplings Red blood cell (RBC) adhesion to endothelial cells (count of adhering RBC /mm²) [ Time Frame: 8 weeks ] Patients will be subjected to blood samplings Various hemodynamic criteria using echocardiography at rest and exercise [ Time Frame: 8 weeks ] vaso-occlusive crises and acute chest syndrome [ Time Frame: 8 weeks ] During the 8 weeks (...) for Study: 18 Years and older (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria Inclusion Criteria: Sickle cell disease patient (HbSS or HbS-βthal0), Affiliated to a Health Security program, Consent form signed, Patients in stabilized state at the onset of the experiment: at least one month after an acute adverse event and at least 3 months after a blood transfusion. Exclusion Criteria: Patients whom adhesion/compliance to the protocol appears uncertain, Patient

2015 Clinical Trials

110. Increased Red Blood Cell Stiffness Increases Pulmonary Vascular Resistance and Pulmonary Arterial Pressure Full Text available with Trip Pro

Increased Red Blood Cell Stiffness Increases Pulmonary Vascular Resistance and Pulmonary Arterial Pressure Patients with sickle cell anemia (SCD) and pulmonary hypertension (PH) have a significantly increased risk of sudden death compared to patients with SCD alone. Sickled red blood cells (RBCs) are stiffer, more dense, more frequently undergo hemolysis, and have a sixfold shorter lifespan compared to normal RBCs. Here, we sought to investigate the impact of increased RBC stiffness (...) pressure (mPAP) (13.5 ± 0.6 mmHg at baseline to 23.2 ± 0.7 mmHg after the third injection), pulmonary vascular resistance (PVR) (1.23 ± 0.11 mmHg*min/ml at baseline to 2.24 ± 0.14 mmHg*min/ml after the third injection), and wave reflections (0.31 ± 0.02 at baseline to 0.43 ± 0.03 after the third injection). Chemically stiffened RBCs also decreased cardiac output, but did not change hematocrit, blood viscosity, pulmonary arterial compliance, or heart rate. The main finding of this study

2016 Journal of biomechanical engineering

111. Recommendations on RBC Transfusion Support in Children With Hematologic and Oncologic Diagnoses From the Pediatric Critical Care Transfusion and Anemia Expertise Initiative. Full Text available with Trip Pro

transfusion over simple (nonexchange) transfusion if the child's condition is deteriorating (based on clinical judgment), otherwise a simple, nonexchange RBC transfusion is recommended. There is insufficient evidence to make recommendations on transfusion thresholds for patients with sickle cell disease prior to minor procedures, with acute stroke or with pulmonary hypertension. For patients with oncologic disease or undergoing hematopoietic stem cell transplant, a hemoglobin concentration of 7-8 g/dL (...) the Grading of Recommendations Assessment, Development, and Evaluation method.The hematologic/oncologic subgroup developed 14 recommendations (seven clinical, seven research); all achieved greater than 80% agreement. In patients with sickle cell disease, Transfusion and Anemia Expertise Initiative recommends: 1) RBC transfusion to achieve a target hemoglobin concentration of 10 g/dL rather than hemoglobin of less than 30% prior to surgical procedures requiring general anesthesia and 2) exchange

2018 Pediatric Critical Care Medicine

112. Efficacy and Safety Study to Evaluate MT-6548 in Hemodialysis Subjects Not Receiving ESAs With Anemia Associated With Chronic Kidney Disease in Japan

≥ 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) at the first day of 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 fundal disease Severe heart failure (New York Heart Association Class IV) Cerebrovascular

2018 Clinical Trials

113. Efficacy and Safety Study to Evaluate MT-6548 in Hemodialysis Subjects Currently Receiving ESAs With Anemia Associated With Chronic Kidney Disease in Japan

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) at the first day of 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 fundal disease Severe heart failure (New York Heart Association Class IV) Cerebrovascular disorder or acute coronary syndrome (hospitalization due to unstable angina

2018 Clinical Trials

114. Renal Cell Carcinoma

in Europe. BJU Int, 2008. 101: 949. 13. King, S.C., et al. Continued increase in incidence of renal cell carcinoma, especially in young patients and high grade disease: United States 2001 to 2010. J Urol, 2014. 191: 1665. 14. Hidayat, K., et al. Blood pressure and kidney cancer risk: meta-analysis of prospective studies. J Hypertens, 2017. 35: 1333. 15. Lotan, Y., et al. Renal-cell carcinoma risk estimates based on participants in the prostate, lung, colorectal, and ovarian cancer screening trial (...) ., et al. Management and outcomes of patients with renal medullary carcinoma: a multicentre collaborative study. BJU Int, 2017. 120: 782. 36. Iacovelli, R., et al. Clinical outcome and prognostic factors in renal medullary carcinoma: A pooled analysis from 18 years of medical literature. Can Urol Assoc J, 2015. 9: E172. 37. Alvarez, O., et al. Renal medullary carcinoma and sickle cell trait: A systematic review. Pediatr Blood Cancer, 2015. 62: 1694. 38. Beckermann, K.E., et al. Clinical

2019 European Association of Urology

115. Tadalafil for Pulmonary Hypertension Due to Chronic Lung Disease

with untreated moderate or severe obstructive sleep apnea (AHI>15) Patients with any coagulopathy Patients requiring nitrate therapy for any clinical indication Patients with an active prescription for pulmonary vasodilator medication other than oxygen Patients with a history of nonarteritic anterior ischemic optic neuropathy Contraindication to tadalafil use including allergy to: any PDE-5 inhibitor anatomical deformations of the penis sickle cell anemia multiple myeloma leukemia bleeding disorders active (...) : Group 3 (PH associated with lung disease and/or hypoxemia) specifically, Group 3.1 (chronic obstructive pulmonary disease [COPD]) as the major criteria. Patients may also have minor clinical features associated with 3.2 (Interstitial disease) (such as mild fibrosis on high resolution chest CT, but total lung capacity>80% predicted) and 3.3 (sleep disordered breathing) (AHI <15 or 20/hour). 6-minute walk distance between 50-450 meters at screening visit. Exclusion Criteria: PH belonging

2013 Clinical Trials

116. Hydroxyurea in Pulmonary Arterial Hypertension

-existing class of bone marrow diseases called myeloproliferative disorders (MPDs). We and others have recently shown that patients with PAH have bone marrow changes similar to those seen in patients with MPDs, even without other signs and symptoms of those bone marrow diseases such as anemia or high platelet and white blood cell counts. Compared to healthy volunteers, patients with PAH have a higher frequency of immature stem and progenitor cells able to produce blood cells and vascular wall cells (...) marrow and blood of PAH patients causes the lung blood vessel disease. The drug hydroxyurea is used to inhibit the abnormally high level of bone marrow cell proliferation in patients with MPDs. It has been shown to reduce the numbers of circulating immature bone marrow cells in patients with MPDs. Hydroxyurea has been available for almost fifty years, and has been used to treat patients with MPDs, sickle cell anemia, and congenital heart disease for very prolonged periods of time, up to twenty

2013 Clinical Trials

117. A monocyte-TNF-endothelial activation axis in sickle transgenic mice: Therapeutic benefit from TNF blockade. Full Text available with Trip Pro

A monocyte-TNF-endothelial activation axis in sickle transgenic mice: Therapeutic benefit from TNF blockade. Elaboration of tumor necrosis factor (TNF) is a very early event in development of ischemia/reperfusion injury pathophysiology. Therefore, TNF may be a prominent mediator of endothelial cell and vascular wall dysfunction in sickle cell anemia, a hypothesis we addressed using NY1DD, S+SAntilles , and SS-BERK sickle transgenic mice. Transfusion experiments revealed participation (...) of abnormally activated blood monocytes exerting an endothelial activating effect, dependent upon Egr-1 in both vessel wall and blood cells, and upon NFκB(p50) in a blood cell only. Involvement of TNF was identified by beneficial impact from TNF blockers, etanercept and infliximab, with less benefit from an IL-1 blocker, anakinra. In therapeutic studies, etanercept ameliorated multiple disturbances of the murine sickle condition: monocyte activation, blood biomarkers of inflammation, low platelet count

2017 American journal of hematology

118. Renal Cell Carcinoma

in Europe. BJU Int, 2008. 101: 949. 13. King, S.C., et al. Continued increase in incidence of renal cell carcinoma, especially in young patients and high grade disease: United States 2001 to 2010. J Urol, 2014. 191: 1665. 14. Hidayat, K., et al. Blood pressure and kidney cancer risk: meta-analysis of prospective studies. J Hypertens, 2017. 35: 1333. 15. Lotan, Y., et al. Renal-cell carcinoma risk estimates based on participants in the prostate, lung, colorectal, and ovarian cancer screening trial (...) ., et al. Management and outcomes of patients with renal medullary carcinoma: a multicentre collaborative study. BJU Int, 2017. 120: 782. 36. Iacovelli, R., et al. Clinical outcome and prognostic factors in renal medullary carcinoma: A pooled analysis from 18 years of medical literature. Can Urol Assoc J, 2015. 9: E172. 37. Alvarez, O., et al. Renal medullary carcinoma and sickle cell trait: A systematic review. Pediatr Blood Cancer, 2015. 62: 1694. 38. Beckermann, K.E., et al. Clinical

2018 European Association of Urology

119. Nonmyeloablative Peripheral Blood Mobilized Hematopoietic Precursor Cell Transplantation for Sickle Cell Disease and Beta-thalassemia in People With Higher Risk of Transplant Failure

Nonmyeloablative Peripheral Blood Mobilized Hematopoietic Precursor Cell Transplantation for Sickle Cell Disease and Beta-thalassemia in People With Higher Risk of Transplant Failure Nonmyeloablative Peripheral Blood Mobilized Hematopoietic Precursor Cell Transplantation for Sickle Cell Disease and Beta-thalassemia in People With Higher Risk of Transplant Failure - 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 studies before adding more. Nonmyeloablative Peripheral Blood Mobilized Hematopoietic Precursor Cell Transplantation for Sickle Cell Disease and Beta-thalassemia in People With Higher Risk of Transplant Failure The safety and scientific validity of this study is the responsibility of the study sponsor and investigators

2014 Clinical Trials

120. Stem Cell Gene Therapy for Sickle Cell Disease

or brain MRI demonstrating previous stroke Administration of regular RBC transfusions for equal or longer than 1 year to prevent vaso-occlusive crises or other sickle cell disease complications or to maintain Hb >6. Pulmonary arterial hypertension with tricuspid regurgitant jet velocity > 2.5 m/sec. At least one episode of acute chest syndrome that required hospitalization, intubation, and mechanical ventilation support within the 2 years prior to enrollment At least 2 acute sickle pain crises (...) for Regenerative Medicine (CIRM) Information provided by (Responsible Party): Donald B. Kohn, M.D., University of California, Los Angeles Study Details Study Description Go to Brief Summary: This Phase I clinical trial will assess the safety and initial evidence for efficacy of an autologous transplant of lentiviral vector modified peripheral blood for adults with severe sickle cell disease. Condition or disease Intervention/treatment Phase Sickle Cell Disease Biological: βAS3-FB vector transduced peripheral

2014 Clinical Trials

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