NCT00000592

Brief Summary

To reduce episodes of first time stroke by 75 percent in children with sickle cell anemia by the administration of prophylactic transfusion therapy.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jul 1994

Longer than P75 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1994

Completed
5.3 years until next milestone

First Submitted

Initial submission to the registry

October 27, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 1999

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2000

Completed
Last Updated

December 23, 2015

Status Verified

November 1, 2005

First QC Date

October 27, 1999

Last Update Submit

December 21, 2015

Conditions

Anemia, Sickle CellCerebral Embolism and ThrombosisCerebrovascular DisordersHematologic DiseasesHemoglobinopathies

Interventions

blood transfusionPROCEDURE

Eligibility Criteria

Age2 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Pediatric patients, ages 24 months to 16 years, with sickle cell anemia or S-beta zero thalassemia.

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

Sponsors & Collaborators

Related Publications (14)

  • Adams RJ, McKie VC, Brambilla D, Carl E, Gallagher D, Nichols FT, Roach S, Abboud M, Berman B, Driscoll C, Files B, Hsu L, Hurlet A, Miller S, Olivieri N, Pegelow C, Scher C, Vichinsky E, Wang W, Woods G, Kutlar A, Wright E, Hagner S, Tighe F, Waclawiw MA, et al. Stroke prevention trial in sickle cell anemia. Control Clin Trials. 1998 Feb;19(1):110-29. doi: 10.1016/s0197-2456(97)00099-8.

    PMID: 9492971BACKGROUND

  • Adams RJ, McKie VC, Hsu L, Files B, Vichinsky E, Pegelow C, Abboud M, Gallagher D, Kutlar A, Nichols FT, Bonds DR, Brambilla D. 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 Jul 2;339(1):5-11. doi: 10.1056/NEJM199807023390102.

    PMID: 9647873BACKGROUND

  • Cohen AR. Sickle cell disease--new treatments, new questions. N Engl J Med. 1998 Jul 2;339(1):42-4. doi: 10.1056/NEJM199807023390109. No abstract available.

    PMID: 9647880BACKGROUND

  • Adams RJ. Lessons from the Stroke Prevention Trial in Sickle Cell Anemia (STOP) study. J Child Neurol. 2000 May;15(5):344-9. doi: 10.1177/088307380001500511.

    PMID: 10830201BACKGROUND

  • Miller ST, Wright E, Abboud M, Berman B, Files B, Scher CD, Styles L, Adams RJ; STOP Investigators. Impact of chronic transfusion on incidence of pain and acute chest syndrome during the Stroke Prevention Trial (STOP) in sickle-cell anemia. J Pediatr. 2001 Dec;139(6):785-9. doi: 10.1067/mpd.2001.119593.

    PMID: 11743502BACKGROUND

  • Files B, Brambilla D, Kutlar A, Miller S, Vichinsky E, Wang W, Granger S, Adams RJ. Longitudinal changes in ferritin during chronic transfusion: a report from the Stroke Prevention Trial in Sickle Cell Anemia (STOP). J Pediatr Hematol Oncol. 2002 May;24(4):284-90. doi: 10.1097/00043426-200205000-00013.

    PMID: 11972097BACKGROUND

  • Nichols FT, Jones AM, Adams RJ. Stroke prevention in sickle cell disease (STOP) study guidelines for transcranial Doppler testing. J Neuroimaging. 2001 Oct;11(4):354-62. doi: 10.1111/j.1552-6569.2001.tb00063.x.

    PMID: 11677874BACKGROUND

  • 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: 11552063BACKGROUND

  • Pegelow CH, Wang W, Granger S, Hsu LL, Vichinsky E, Moser FG, Bello J, Zimmerman RA, Adams RJ, Brambilla D; STOP Trial. Silent infarcts in children with sickle cell anemia and abnormal cerebral artery velocity. Arch Neurol. 2001 Dec;58(12):2017-21. doi: 10.1001/archneur.58.12.2017.

    PMID: 11735775BACKGROUND

  • Adams RJ, Brambilla DJ, Granger S, Gallagher D, Vichinsky E, Abboud MR, Pegelow CH, Woods G, Rohde EM, Nichols FT, Jones A, Luden JP, Bowman L, Hagner S, Morales KH, Roach ES; STOP Study. Stroke and conversion to high risk in children screened with transcranial Doppler ultrasound during the STOP study. Blood. 2004 May 15;103(10):3689-94. doi: 10.1182/blood-2003-08-2733. Epub 2004 Jan 29.

    PMID: 14751925BACKGROUND

  • Hsu LL, Miller ST, Wright E, Kutlar A, McKie V, Wang W, Pegelow CH, Driscoll C, Hurlet A, Woods G, Elsas L, Embury S, Adams RJ; Stroke Prevention Trial (STOP) and the Cooperative Study of Sickle Cell Disease (CSSCD). Alpha Thalassemia is associated with decreased risk of abnormal transcranial Doppler ultrasonography in children with sickle cell anemia. J Pediatr Hematol Oncol. 2003 Aug;25(8):622-8. doi: 10.1097/00043426-200308000-00007.

    PMID: 12902915BACKGROUND

  • Abboud MR, Cure J, Granger S, Gallagher D, Hsu L, Wang W, Woods G, Berman B, Brambilla D, Pegelow C, Lewin J, Zimmermann RA, Adams RJ; STOP study. Magnetic resonance angiography in children with sickle cell disease and abnormal transcranial Doppler ultrasonography findings enrolled in the STOP study. Blood. 2004 Apr 1;103(7):2822-6. doi: 10.1182/blood-2003-06-1972. Epub 2003 Dec 18.

    PMID: 14684415BACKGROUND

  • 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: 16126058BACKGROUND

  • 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: 19721013DERIVED

MeSH Terms

Conditions

Anemia, Sickle CellIntracranial Embolism and ThrombosisCerebrovascular DisordersHematologic DiseasesHemoglobinopathies

Interventions

Blood Transfusion

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHemic and Lymphatic DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesThromboembolismEmbolism and Thrombosis

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeutics

Study Officials

  • Donald Brambilla

    New England Research Institute Inc.

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
PREVENTION
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 27, 1999

First Posted

October 28, 1999

Study Start

July 1, 1994

Study Completion

August 1, 2000

Last Updated

December 23, 2015

Record last verified: 2005-11