Stroke Prevention in Sickle Cell Anemia (STOP 2)

NCT00006182 | Completed Phase 3

• 2 other identifiers: 68U01HL052016
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

To determine how long blood transfusions are needed for primary stroke prevention. Also, to determine the duration of risk associated with abnormal transcranial Doppler ultrasound (TCD) and to determine the specificity of the stroke risk model developed in STOP 1 in patients with abnormal TCD measurements.

Conditions

Blood Disease; Cerebrovascular Accident; Anemia, Sickle Cell

Interventions

Blood Transfusion PROCEDURE

Eligibility Criteria

• Age: 2 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

No eligibility criteria

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Related Publications (5)

• Vichinsky EP, Luban NL, Wright E, Olivieri N, Driscoll C, Pegelow CH, Adams RJ; Stroke Prevention Trail in Sickle Cell Anemia. Prospective RBC phenotype matching in a stroke-prevention trial in sickle cell anemia: a multicenter transfusion trial. Transfusion. 2001 Sep;41(9):1086-92. doi: 10.1046/j.1537-2995.2001.41091086.x.

  PMID: 11552063 BACKGROUND

• Kral MC, Brown RT. Transcranial Doppler ultrasonography and executive dysfunction in children with sickle cell disease. J Pediatr Psychol. 2004 Apr-May;29(3):185-95. doi: 10.1093/jpepsy/jsh020.

  PMID: 15131136 BACKGROUND

• Wang WC, Morales KH, Scher CD, Styles L, Olivieri N, Adams R, Brambilla D; STOP Investigators. Effect of long-term transfusion on growth in children with sickle cell anemia: results of the STOP trial. J Pediatr. 2005 Aug;147(2):244-7. doi: 10.1016/j.jpeds.2005.02.030.

  PMID: 16126058 BACKGROUND

• Adams RJ, Brambilla D; Optimizing Primary Stroke Prevention in Sickle Cell Anemia (STOP 2) Trial Investigators. Discontinuing prophylactic transfusions used to prevent stroke in sickle cell disease. N Engl J Med. 2005 Dec 29;353(26):2769-78. doi: 10.1056/NEJMoa050460.

  PMID: 16382063 RESULT

• Adamkiewicz TV, Abboud MR, Paley C, Olivieri N, Kirby-Allen M, Vichinsky E, Casella JF, Alvarez OA, Barredo JC, Lee MT, Iyer RV, Kutlar A, McKie KM, McKie V, Odo N, Gee B, Kwiatkowski JL, Woods GM, Coates T, Wang W, Adams RJ. Serum ferritin level changes in children with sickle cell disease on chronic blood transfusion are nonlinear and are associated with iron load and liver injury. Blood. 2009 Nov 19;114(21):4632-8. doi: 10.1182/blood-2009-02-203323. Epub 2009 Aug 31.

  PMID: 19721013 DERIVED

MeSH Terms

Conditions

Hematologic Diseases; Stroke; Anemia, Sickle Cell

Interventions

Blood Transfusion

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Robert Adams

  Augusta University

• Donald Brambilla

  New England Research Institutes, Inc.

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: PREVENTION
• Sponsor Type: NIH

Study Record Dates

• First Submitted: August 21, 2000
• First Posted: August 22, 2000
• Study Start: July 1, 2000
• Study Completion: February 1, 2006
• Last Updated: February 18, 2016

Record last verified: 2005-10