Systematic review of interventional sickle cell trials registered in ClinicalTrials.gov

Clinical Trials

Volumn 12, Issue 6, 2015, Pages 575-583

  Lebensburger, Jeffrey D ^a   Hilliard, Lee M ^a   Pair, Lauren E ^a   Oster, Robert ^b   Howard, Thomas H ^a   Cutter, Gary R ^c  

^a University of Alabama at Birmingham   (United States)

^b University of Alabama at Birmingham   (United States)

^c UNIVERSITY OF ALABAMA AT BIRMINGHAM   (United States)

Author keywords

clinical trials; disparities research; Sickle cell disease; thalassemia

Indexed keywords

HYDROXYUREA;

ACCESS TO INFORMATION; ARTICLE; BONE MARROW TRANSPLANTATION; CLINICAL TRIAL (TOPIC); DATA BASE; DISEASE REGISTRY; EARLY TERMINATION OF CLINICAL TRIAL; HUMAN; INFORMATION DISSEMINATION; INTERNET; IRON OVERLOAD; OUTCOME ASSESSMENT; PAIN; PATIENT PARTICIPATION; PRIORITY JOURNAL; PULMONARY HYPERTENSION; SICKLE CELL ANEMIA; SYSTEMATIC REVIEW; THALASSEMIA; VALIDITY; FACTUAL DATABASE; HEALTH CARE DISPARITY; REGISTER; STATISTICS AND NUMERICAL DATA;

ANEMIA, SICKLE CELL; CLINICAL TRIALS AS TOPIC; DATABASES, FACTUAL; EARLY TERMINATION OF CLINICAL TRIALS; HEALTHCARE DISPARITIES; HUMANS; REGISTRIES;

EID: 84947078259     PISSN: 17407745     EISSN: 17407753     Source Type: Journal    
DOI: 10.1177/1740774515590811     Document Type: Article

References (33)

1. Hassell KL,. Population estimates of sickle cell disease in the U.S. Am J Prev Med 2010; 38: S512-S521.
2. Powars DR, Chan LS, Hiti A, et al. Outcome of sickle cell anemia: a 4-decade observational study of 1056 patients. Medicine 2005; 84: 363-376.
3. Gaston M, Rosse WF,. The cooperative study of sickle cell disease: review of study design and objectives. Am J Pediatr Hematol Oncol 1982; 4: 197-201.
4. Gaston MH, Verter JI, Woods G, et al. Prophylaxis with oral penicillin in children with sickle cell anemia. A randomized trial. N Engl J Med 1986; 314: 1593-1599.
5. Consensus conference. Newborn screening for sickle cell disease and other hemoglobinopathies. JAMA 1987; 258: 1205-1209.
6. Ohene-Frempong K, Weiner SJ, Sleeper LA, et al. Cerebrovascular accidents in sickle cell disease: rates and risk factors. Blood 1998; 91: 288-294.
7. Powars D, Wilson B, Imbus C, et al. The natural history of stroke in sickle cell disease. Am J Med 1978; 65: 461-471.
8. Adams RJ, McKie VC, Hsu L, et al. Prevention of a first stroke by transfusions in children with sickle cell anemia and abnormal results on transcranial Doppler ultrasonography. N Engl J Med 1998; 339: 5-11.
9. Adams RJ, Brambilla D, Optimizing Primary Stroke Prevention in Sickle Cell Anemia Trial I. Discontinuing prophylactic transfusions used to prevent stroke in sickle cell disease. N Engl J Med 2005; 353: 2769-2778.
10. Wang WC, Ware RE, Miller ST, et al. Hydroxycarbamide in very young children with sickle-cell anaemia: a multicentre, randomised, controlled trial (BABY HUG). Lancet 2011; 377: 1663-1672.
11. Thornburg CD, Files BA, Luo Z, et al. Impact of hydroxyurea on clinical events in the BABY HUG trial. Blood 2012; 120: 4304-4310; quiz 4448.
12. Lebensburger JD, Miller ST, Howard TH, et al. Influence of severity of anemia on clinical findings in infants with sickle cell anemia: analyses from the BABY HUG study. Pediatr Blood Cancer 2012; 59: 675-678.
13. Charache S, Terrin ML, Moore RD, et al. Effect of hydroxyurea on the frequency of painful crises in sickle cell anemia. Investigators of the Multicenter Study of Hydroxyurea in Sickle Cell Anemia. N Engl J Med 1995; 332: 1317-1322.
14. Steinberg MH, McCarthy WF, Castro O, et al. The risks and benefits of long-term use of hydroxyurea in sickle cell anemia: a 17.5 year follow-up. Am J Hematol 2010; 85: 403-408.
15. Voskaridou E, Christoulas D, Bilalis A, et al. The effect of prolonged administration of hydroxyurea on morbidity and mortality in adult patients with sickle cell syndromes: results of a 17-year, single-center trial (LaSHS). Blood 2010; 115: 2354-2363.
16. Gadegbeku CA, Stillman PK, Huffman MD, et al. Factors associated with enrollment of African Americans into a clinical trial: results from the African American study of kidney disease and hypertension. Contemp Clin Trials 2008; 29: 837-842.
17. Shavers-Hornaday VL, Lynch CF, Burmeister LF, et al. Why are African Americans under-represented in medical research studies? Impediments to participation. Ethn Health 1997; 2: 31-45.
18. Shavers VL, Lynch CF, Burmeister LF,. Racial differences in factors that influence the willingness to participate in medical research studies. Ann Epidemiol 2002; 12: 248-256.
19. Shavers VL, Lynch CF, Burmeister LF,. Factors that influence African-Americans' willingness to participate in medical research studies. Cancer 2001; 91: 233-236.
20. Corbie-Smith G, Thomas SB, Williams MV, et al. Attitudes and beliefs of African Americans toward participation in medical research. J Gen Intern Med 1999; 14: 537-546.
21. Lebensburger JD, Sidonio RF, Debaun MR, et al. Exploring barriers and facilitators to clinical trial enrollment in the context of sickle cell anemia and hydroxyurea. Pediatr Blood Cancer 2013; 60: 1333-1337.
22. Quinn CT, Stuart MJ, Kesler K, et al. Tapered oral dexamethasone for the acute chest syndrome of sickle cell disease. Br J Haematol 2011; 155: 263-267.
23. Styles L, Wager CG, Labotka RJ, et al. Refining the value of secretory phospholipase A2 as a predictor of acute chest syndrome in sickle cell disease: results of a feasibility study (PROACTIVE). Br J Haematol 2012; 157: 627-636.
24. Peters-Lawrence MH, Bell MC, Hsu LL, et al. Clinical trial implementation and recruitment: lessons learned from the early closure of a randomized clinical trial. Contemp Clin Trials 2012; 33: 291-297.
25. Dampier CD, Smith WR, Wager CG, et al. IMPROVE trial: a randomized controlled trial of patient-controlled analgesia for sickle cell painful episodes: rationale, design challenges, initial experience, and recommendations for future studies. Clin Trials 2013; 10: 319-331.
26. Liem RI, Cole AH, Pelligra SA, et al. Parental attitudes toward research participation in pediatric sickle cell disease. Pediatr Blood Cancer 2010; 55: 129-133.
27. Wynn L, Miller S, Faughnan L, et al. Recruitment of infants with sickle cell anemia to a Phase III trial: data from the BABY HUG study. Contemp Clin Trials 2010; 31: 558-563.
28. US Government Printing Office. 110th Congress Public Law 85., http://www.gpo.gov/fdsys/pkg/PLAW-110publ85/html/PLAW-110publ85.htm (2007,. accessed 27 April 2015).
29. National Institutes of Health. HHS and NIH take steps to enhance transparency of clinical trial results., http://www.nih.gov/news/health/nov2014/od-19.htm (2015,. accessed 27 April 2015).
30. Barst RJ, Mubarak KK, Machado RF, et al. Exercise capacity and haemodynamics in patients with sickle cell disease with pulmonary hypertension treated with bosentan: results of the ASSET studies. Br J Haematol 2010; 149: 426-435.
31. Wang W, Brugnara C, Snyder C, et al. The effects of hydroxycarbamide and magnesium on haemoglobin SC disease: results of the multi-centre CHAMPS trial. Br J Haematol 2011; 152: 771-776.
32. Desai PC, Brittain JE, Jones SK, et al. A pilot study of eptifibatide for treatment of acute pain episodes in sickle cell disease. Thromb Res 2013; 132: 341-345.
33. Badaki-Makun O, Scott JP, Panepinto JA, et al. Intravenous magnesium for pediatric sickle cell vaso-occlusive crisis: methodological issues of a randomized controlled trial. Pediatr Blood Cancer 2014; 61: 1049-1054.