Clinical Trials Logo

Sickle Cell Disease clinical trials

View clinical trials related to Sickle Cell Disease.

Filter by:

NCT ID: NCT03431935 Recruiting - Sickle Cell Disease Clinical Trials

Predictors and Outcomes in Patients With Sickle Cell Disease

Start date: February 2018
Phase: N/A
Study type: Observational

Children with sickle cell disease (SCD) are living longer with the advent of medical advances such as prophylactic penicillin, chronic transfusion, and hydroxyurea. Despite greater longevity in SCD, the period following the transition from pediatric to adult care is critical; youth aged 18-30 years are at high risk for mortality and have high rates of healthcare utilization, leading to high healthcare costs. As such, health care transition (HCT) programs have been created to prepare patients for adult-centered care and subsequently, improve health outcomes. However, very few programs have been evaluated for effectiveness in achieving optimal health outcomes in SCD. This paucity of program evaluation is attributed to a lack of identifiable predictors and outcomes. Researchers at St. Jude Children's Research Hospital want to identify factors and patterns of successful HCT. This information will be used to develop approaches to best evaluate HCT interventions and identify areas of improvement of HCT programming. PRIMARY OBJECTIVE: Describe hospital utilization, treatment adherence, and health-related quality of life in a cohort of patients with sickle cell disease (SCD) who will transfer to adult care during the study period. SECONDARY OBJECTIVE: Examine the associations between various factors and health care transition (HCT) outcomes.

NCT ID: NCT03421756 Not yet recruiting - Sickle Cell Disease Clinical Trials

Stem Cell Transplant in Patients With Severe Sickle Cell Disease

Start date: February 15, 2018
Phase: Early Phase 1
Study type: Interventional

This is a prospective pilot study of matched-related donor allogeneic stem cell transplantation in adults with severe sickle cell disease using a matched-sibling PBSC graft with a non-myeloablative conditioning regimen (Alemtuzumab).

NCT ID: NCT03417947 Not yet recruiting - Sickle Cell Disease Clinical Trials

Vitamin D Supplementation in Children With Sickle Cell Disease

Start date: May 1, 2018
Phase: Phase 3
Study type: Interventional

Sickle cell disease (SCD) is a genetic disease characterized by abnormal hemoglobin, the main constituent of red blood cells. People with SCD have nutritional deficiencies, and vitamin D deficiency is one of the most common. Symptoms of vitamin D deficiency are similar to those of SCD and include chronic pain and bone complications. Correcting vitamin D nutrition of children with SCD represents a treatment that will improve their health. A single oral high-dose of vitamin D3 will be given to SCD children during one of their follow-up visits at the SCD clinic of CHU Sainte-Justine, Montreal, Canada. This mode of administration was chosen to ensure a better adherence to the treatment. The investigators will determine whether this dose is safe and its administration feasible in clinic. The impact of this dose on blood vitamin D and calcium, urinary calcium, growth, inflammation, bone health, pain and quality of life will also be assessed. This study intends to propose a new intervention to improve the nutrition of children with this disease.

NCT ID: NCT03405688 Not yet recruiting - Sickle Cell Disease Clinical Trials

Transfusion in Sickle Cell Disease: Screening of Sickle Cell Disease Trait in Blood Donors

Start date: February 2018
Phase: N/A
Study type: Interventional

Bearers of the sickle cell allele (S) are currently eligible for blood donations in Belgium. As blood donors are not tested for this allele, their heterozygous status is unknown. However, guidelines recommend to transfuse sickle cell patients with blood that is negative for the 'S' hemoglobin. To the investigator's knowledge, no study has been conducted to evaluate the impact of transfusion with blood originating from heterozygous donors on the transfusion performance and the improvement of clinical status of the sickle cell disease patients.

NCT ID: NCT03405402 Not yet recruiting - Sickle Cell Disease Clinical Trials

Transfusion in Sickle Cell Disease: Risk Factors for Alloimmunization

Start date: February 2018
Phase: N/A
Study type: Interventional

Sickle cell patients have a high prevalence of alloimmunization. This high rate of alloimmunization can be partially explained by the existence of an antigenic difference between the predominantly Caucasian donor population and the sickle cell patients of African origin. Genetic and environmental risk factors have also been described. The main risk factors that have been shown in retrospective or cross-sectional studies are some HLA alleles, the age of the patient, the number of leukocyte-depleted erythrocyte concentrates (CED) transfused, the number of transfusion episodes, the age of the CEDs, the existence of an inflammatory event at the time of transfusion and the presence of anti-erythrocyte autoantibodies.There is also evidence of an impaired TH response but the underlying immunological mechanism is not fully understood. The aim of this study is to study the prevalence and the risk factors for anti-erythrocyte alloimmunization and to try to understand the immunological mechanisms.

NCT ID: NCT03401125 Not yet recruiting - Sickle Cell Disease Clinical Trials

Risk Factors for Allo-immunization in Sickle Cell Disease

Start date: February 2018
Phase: N/A
Study type: Observational

Sickle cell patients have a high prevalence of alloimmunization. This high rate of alloimmunization can be partially explained by the existence of an antigenic difference between the predominantly Caucasian donor population and the sickle cell patients of African origin. Genetic and environmental risk factors have also been described. The main risk factors that have been shown in retrospective or cross-sectional studies are some HLA alleles, the age of the patient, the number of leukocyte-depleted erythrocyte concentrates (CED) transfused, the number of transfusion episodes, the age of the CEDs, the existence of an inflammatory event at the time of transfusion and the presence of anti-erythrocyte autoantibodies.There is also evidence of an impaired TH response but the underlying immunological mechanism is not fully understood. The aim of this study is to study the prevalence and the risk factors for anti-erythrocyte alloimmunization in pediatric and adult patients with Sickle Cell Disease (with a SS genotype) who are being followed at Queen Fabiola University Children's Hospital (HUDERF) and at the CHU Brugmann Hospital. The identification of risk factors would allow the investigators to improve, or at least adapt, their transfusion policy to certain clinical or immuno-haematological situations.

NCT ID: NCT03401112 Recruiting - Sickle Cell Disease Clinical Trials

A Study of IMR-687 in Adult Patients With Sickle Cell Anaemia (Homozygous HbSS or Sickle-β0 Thalassemia)

Start date: January 2018
Phase: Phase 2
Study type: Interventional

A Phase 2a randomized, placebo-controlled, multicenter study of orally administered IMR-687 in adults with Sickle Cell Anaemia (SCA).

NCT ID: NCT03387033 Not yet recruiting - Depression Clinical Trials

Role of Virtual Reality (VR) in Patients With Sickle Cell Disease (SCD)

Start date: February 1, 2018
Phase: N/A
Study type: Interventional

Patients with sickle cell disease (SCD) and cancer often have complicated courses while hospitalized and often deal with pain, anxiety and depression. Advances in the field of technology provide potential avenues for innovative and improved care models for our patients. Virtual reality (VR) has been recently utilized to improve anxiety and pain in a variety of patient populations including children undergoing elective surgery and children experiencing intravenous cannulation in the Emergency Department. Patients with SCD and cancer, both adults and children, are a group of patients that can benefit from VR as part of their care. Over the past four years, our team has successfully implemented several self-developed mobile applications ("apps") for our patients, in addition to integrating objective data (heart rate, activity, stress) from wearable activity trackers. The investigators now propose implementing a feasibility study followed by a pilot study and randomized-controlled trial of the use of VR in patients with SCD and cancer. The investigators plan to assess pain and anxiety prior to the session as well as following the session in hospitalized patients and outpatients with SCD and cancer. The sessions will include a ten-minute relaxation response introductory narrative segment (deep breathing and mindfulness) followed by a ten-minute narrated and immersive VR. Heart rate will be tracked using an Apple iWatch for 30 minutes prior to the session, during the session, and following the session. We anticipate VR will not only be a feasible method to provide non-pharmacologic treatment, but will also significantly reduce pain and anxiety.

NCT ID: NCT03383913 Not yet recruiting - Sickle Cell Disease Clinical Trials

HRV-B for Symptom Management in Sickle Cell Patients

Start date: January 22, 2018
Phase: N/A
Study type: Interventional

This study will test the hypothesis that Heart Rate Variability Biofeedback (HRV-B) restores autonomic balance and reduces pain and other symptoms among patients with sickle cell disease (SCD).The specific aims of this study are to: (1) conduct a randomized, wait list controlled, pilot intervention trial to determine whether HRV-B increases HRV coherence among SCD participants (minimum N of 30, up to 50 total); (2) determine whether HRV-B reduces pain, stress, fatigue, depression or insomnia among SCD participants; and (3) determine whether increases in HRV coherence are associated improvements in pain, stress, fatigue, depression, or sleep among study participants.

NCT ID: NCT03376893 Recruiting - Stroke Clinical Trials

Epidemiology of Silent and Overt Strokes in Sickle Cell Anemia

Start date: June 2, 2017
Phase: N/A
Study type: Observational

Sickle cell anemia is a rare disease occurring in an estimated 66,000 children and adults, often poor and underserved, in the United States. Strokes and silent strokes contribute significantly to illness burden in adults with sickle cell anemia, resulting in impairment, challenges with school and job performance, and premature death. Five NIH studies have identified therapies to prevent overt and silent strokes in children with sickle cell anemia, including monthly blood transfusion therapy (for preventing initial and recurrent strokes) and hydroxyurea (for preventing initial strokes). However, no stroke trials have established therapeutic approaches for adults with sickle cell anemia, despite the observation that at least 99% of children with sickle cell anemia in high-income countries reach adulthood, and approximately 60% of adults will experience one or more strokes (~50% with silent strokes and ~10% with overt strokes). Strokes in adults with sickle cell anemia have simply not been well studied. Therapies applied in children may not be effective for stroke prevention in adults with sickle cell anemia. Identifying subgroups of adults with sickle cell anemia and higher incidence coupled with the contribution of established stroke risk factors in the general population (smoking, diabetes, obesity, renal disease) will provide the prerequisite data required for the first ever phase III clinical trials focused on secondary stroke prevention in adults. In six adult sickle cell disease centers, the investigators will conduct a prospective cohort study to test the primary hypothesis that the incidence of stroke recurrence in adults with silent strokes treated with hydroxyurea will be greater than in those without strokes treated with hydroxyurea. We will test two secondary hypotheses: 1) adults with sickle cell anemia and silent strokes have cognitive deficits when compared to adults with sickle cell anemia without silent strokes; and 2) adults with sickle cell anemia and strokes receiving regular blood transfusion will have a higher incidence of stroke recurrence than adults with sickle cell anemia without strokes. We will recruit at least 72 individuals with sickle cell anemia and history of silent stroke receiving hydroxyurea therapy, at least 72 individuals with sickle cell anemia and no history of stroke, and at least 50 individuals with sickle cell anemia and history of overt stroke receiving transfusion therapy.