scholarly journals Exploring barriers and facilitators to clinical trial enrollment in the context of sickle cell anemia and hydroxyurea

2013 ◽  
Vol 60 (8) ◽  
pp. 1333-1337 ◽  
Author(s):  
Jeffrey D. Lebensburger ◽  
Robert F. Sidonio ◽  
Michael R. DeBaun ◽  
Monika M. Safford ◽  
Thomas H. Howard ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Sickle Cell ◽  
Sickle Cell Anemia ◽  
Barriers And Facilitators ◽  
Clinical Trial Enrollment

scholarly journals Randomization is not associated with socio-economic and demographic factors in a multi-center clinical trial of children with sickle cell anemia

2014 ◽  
Vol 61 (9) ◽  
pp. 1529-1535 ◽  
Author(s):  
Dionna O. Roberts ◽  
Brittany Covert ◽  
Mark J. Rodeghier ◽  
Nagina Parmar ◽  
Michael R. DeBaun ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Sickle Cell ◽  
Sickle Cell Anemia ◽  
Demographic Factors

scholarly journals Prevention of conversion to abnormal transcranial Doppler with hydroxyurea in sickle cell anemia: A Phase III international randomized clinical trial

2015 ◽  
Vol 90 (12) ◽  
pp. 1099-1105 ◽  
Author(s):  
Jane S. Hankins ◽  
Mary Beth McCarville ◽  
Angela Rankine-Mullings ◽  
Marvin E. Reid ◽  
Clarisse L.C. Lobo ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Sickle Cell ◽  
Sickle Cell Anemia ◽  
Transcranial Doppler ◽  
Phase Iii

Perceived benefits and risks of participation in a clinical trial for Ugandan children with sickle cell anemia

2019 ◽  
Vol 67 (2) ◽  
Author(s):  
Aubri S. Carman ◽  
Casey Sautter ◽  
Juliana N. Anyanwu ◽  
Andrew S. Ssemata ◽  
Robert O. Opoka ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Sickle Cell ◽  
Sickle Cell Anemia ◽  
Perceived Benefits

scholarly journals Zinc for Infection Prevention in Sickle Cell Anemia (ZIPS): Study Protocol for a Randomized Placebo-Controlled Trial in Ugandan children with Sickle Cell Anemia

2019 ◽  
Author(s):  
Dibyadyuti Datta ◽  
Ruth Namazzi ◽  
Andrea L. Conroy ◽  
Sarah E. Cusick ◽  
Heather A. Hume ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Sickle Cell ◽  
Sickle Cell Anemia ◽  
Zinc Supplementation ◽  
Controlled Trial ◽  
Sub Saharan Africa ◽  
Invasive Infection ◽  
Risk Of Infection ◽  
African Children ◽  
Increased Risk

Abstract Background Sickle cell anemia (SCA) is the most common inherited hemoglobinopathy worldwide. Infection is a major cause of illness and death in children with SCA, especially in sub Saharan Africa where an estimated 50-90% of affected children die before their fifth birthday. Interventions to reduce the incidence and severity of infections are needed urgently. A high proportion of adults and children with SCA are zinc-deficient, and zinc deficiency leads to impaired immunity and an increased risk of infection. Zinc supplementation has been shown to decrease the risk of infection in adolescents and adults, but there is no data on the effectiveness of zinc for prevention of infection in children <5 years of age with SCA. Methods/Design The study will be a randomized, placebo-controlled, double-blind clinical trial in which 250 Ugandan children 1.00-4.99 years of age with SCA will receive daily zinc supplementation (10 mg oral dispersible tablet) or identical placebo for 12 months. Discussion If this trial shows a reduction in severe or invasive infection incidence, it would be the basis for a multi-site, multi-country clinical trial to assess real-world safety and efficacy of zinc in African children with SCA. Since zinc is safe, inexpensive, and easy to administer, this trial has the potential to improve the health of hundreds of thousands of African children with SCA through reduction of infection-related morbidity and mortality. Trial Registration Clinicaltrials.gov identifier: NCT03528434. Registered on May 17, 2018 Protocol Version: 1.0. Date: Dec 11, 2017 Sponsor: Indiana University. Sponsor’s protocol identifier: 1712339562

A Preliminary Report on Piracetam in Sickle Cell Anemia: A Double-Blind Crossover Clinical Trial and Effects on Erythrocyte Survival

1983 ◽  
Vol 3 (4) ◽  
pp. 233-235
Author(s):  
Muhammad A. Mikati ◽  
Hassan M. Solh ◽  
Denise E. Deryan ◽  
Itaf F. Sahli ◽  
Ibrahim A. Dabbous
Keyword(s):  
Clinical Trial ◽  
Sickle Cell ◽  
Sickle Cell Anemia ◽  
Preliminary Report ◽  
Double Blind ◽  
Erythrocyte Survival

Impact of Hydroxyurea On Employment Among Patients with Sickle Cell Anemia.

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 2485-2485 ◽  
Author(s):  
Samir K. Ballas ◽  
Robert L Bauserman ◽  
William F. McCarthy ◽  
Myron A Waclawiw ◽  
Bruce A Barton
Keyword(s):  
Clinical Trial ◽  
Sickle Cell ◽  
Sickle Cell Anemia ◽  
Conflicts Of Interest ◽  
Negative Impact ◽  
Double Blind Study ◽  
Full Time ◽  
Timely Initiation ◽  
Employment Patterns

Abstract Abstract 2485 Poster Board II-462 Introduction: Sickle cell disease (SCD) has a negative impact on education, career development, employment, and work history. Repeated painful crises and chronic complications (leg ulcers, retinopathy, etc.) can limit employment options and interfere with work attendance. Young adults frequently report that their health has interrupted educational plans and prevented their finding a full-time job. The purpose of this study is to examine employment patterns over time among SCD patients enrolled in the Multicenter Study of Hydroxyurea (MSH) in Sickle Cell Anemia, a randomized placebo-controlled double-blind study of whether hydroxyurea (HU) treatment could reduce the rate of painful crises in SCD. Patients and Methods: The N=299 adult patients in MSH were recruited from 21 sites across the U.S. and Canada, and were evenly distributed between males and females. Patients were at least 18 years old with a diagnosis of sickle cell anemia and at least 3 painful crises in the year prior to entry. The trial was terminated early due to a beneficial effect of HU on painful crises, but led to an observational follow-up and extension.Patients reported employment status at baseline and at 12, 24, and 36 months in the clinical trial; during the follow-up, employment data was collected in years 1-5 and 7-9. We categorized patients as ‘employed' (working full or part time) or ‘unemployed' (any other response, including unemployed, disabled, in school, retired, etc.). About 90% of all responses in this category were either unemployed or disabled, rather than other options such as in school.We examined employment history in 2 ways. First, changes from baseline to 24 months in the clinical trial (there was little data for 36 months due to the early termination) were categorized as continuous employment, continuous unemployment, shift from employment to unemployment, or from unemployment to employment; chi-square analyses were used to compare groups. Second, using all available data from the trial and follow-up, we calculated cumulative employment for each patient as the proportion of years employed out of all years of available data (up to the maximum possible of 12 years of data). This allowed us to obtain values for all patients despite missing data from some years. Linear regression models were used to compare groups.Employment history was compared between the placebo group and HU treatment responders and nonresponders (responders were defined as patients with % fetal hemoglobin < 15% before treatment and > 15% two years later). Many patients moved from placebo to HU following the clinical trial, but original group assignment was used for analyses because the HU group would have had the earliest and most consistent exposure to HU. Results: Descriptive data were suggestive of better employment outcomes for HU responders. During the clinical trial, 41% of responders and 29% of nonresponders were continuously employed or moved to employment. However, differences between responders, nonresponders and placebo patients were not statistically significant (p=.73). Across all years of data, responders were employed in 34% of years, versus about 30% for nonresponders and placebo patients. However, differences between groups were again not statistically significant (p=.71). Conclusions: Recurrent episodes of acute and chronic pain are characteristic of SCD. In MSH, HU treatment significantly reduced the rate of painful crises, the need for blood transfusion, and morbidity and mortality. Although some aspects of quality of life improved in this cohort of patients with moderate to severe SCD, employment patterns during the clinical trial and overall proportion of years in employment did not significantly differ. These findings point to two important aspects of HU treatment.First, employment effects may differ with more timely initiation of HU. MSH patients had moderate to severe SCD at enrollment, and some already had related disabilities (such as avascular necrosis) unaffected by HU. Earlier initiation of HU may prevent or delay onset of the most serious SCD complications that can negatively affect employment. Second, data such as those reported here may be of use in counseling young SCD patients regarding employment. The Americans with Disabilities Act defines rights of disabled/impaired persons in the workplace and awareness of this may lessen stress due to fear of losing a job or being unable to find employment. Disclosures: No relevant conflicts of interest to declare.

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