Last reviewed · How we verify

NCT01801423: SPIN

Sickle Cell Disease - Stroke Prevention in Nigeria Trial

Completed NA Last updated 3 August 2020
What this trial tests

NA trial testing Hydroxyurea in Sickle Cell Anemia in 29 participants. Completed in 31 January 2019.

Timeline
24 April 2013
Primary endpoint
31 January 2019
31 January 2019

Quick facts

Lead sponsorVanderbilt University Medical Center
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment29
Start date24 April 2013
Primary completion31 January 2019
Estimated completion31 January 2019
Sites1 location across Nigeria

Drugs / interventions tested

Conditions studied

Sponsor

Vanderbilt University Medical Center

Who can join

Adults 5 to 12, any sex, with Sickle Cell Anemia or Sickle Cell Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Given large absolute numbers of individuals with sickle cell disease in Nigeria, hydroxyurea therapy for all individuals with sickle cell disease may not be initially feasible; however, a targeted strategy of hydroxyurea use for primary prevention of strokes is an alternative to the standard therapy (observation) for high-risk individuals. The investigators propose a feasibility study, Sickle Cell Disease - Stroke Prevention in Nigeria (SPIN) Trial, to determine whether hydroxyurea can be used for primary prevention of strokes in Nigerian children with sickle cell anemia.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Sickle cell anemia in sub-Saharan Africa: advancing the clinical paradigm through partnerships and research.
    McGann PT, Hernandez AG, Ware RE. · · 2017 · cited 75× · PMID 27821508 · DOI 10.1182/blood-2016-09-702324
  2. Hydroxyurea for primary stroke prevention in children with sickle cell anaemia in Nigeria (SPRING): a double-blind, multicentre, randomised, phase 3 trial.
    Abdullahi SU, Jibir BW, Bello-Manga H, Gambo S, et al · · 2022 · cited 74× · PMID 34971579 · DOI 10.1016/s2352-3026(21)00368-9
  3. Feasibility trial for primary stroke prevention in children with sickle cell anemia in Nigeria (SPIN trial).
    Galadanci NA, Umar Abdullahi S, Vance LD, Musa Tabari A, et al · · 2017 · cited 55× · PMID 28439953 · DOI 10.1002/ajh.24770
  4. Moderate fixed-dose hydroxyurea for primary prevention of strokes in Nigerian children with sickle cell disease: Final results of the SPIN trial.
    Galadanci NA, Abdullahi SU, Ali Abubakar S, Wudil Jibir B, et al · · 2020 · cited 48× · PMID 32510680 · DOI 10.1002/ajh.25900
  5. Effective use of hydroxyurea for sickle cell anemia in low-resource countries.
    Power-Hays A, Ware RE. · · 2020 · cited 45× · PMID 32205588 · DOI 10.1097/moh.0000000000000582
  6. Primary stroke prevention in Nigerian children with sickle cell disease (SPIN): challenges of conducting a feasibility trial.
    Galadanci NA, Abdullahi SU, Tabari MA, Abubakar S, et al · · 2015 · cited 35× · PMID 25399822 · DOI 10.1002/pbc.25289
  7. Hydroxyurea for secondary stroke prevention in children with sickle cell anemia in Nigeria: a randomized controlled trial.
    Abdullahi SU, Sunusi S, Abba MS, Sani S, et al · · 2023 · cited 31× · PMID 36322937 · DOI 10.1182/blood.2022016620
  8. Associations of transcranial doppler velocity, age, and gender with cognitive function in children with sickle cell anemia in Nigeria.
    Prussien KV, Salihu A, Abdullahi SU, Galadanci NA, et al · · 2019 · cited 19× · PMID 30269648 · DOI 10.1080/09297049.2018.1526272

Verify or expand the search:

Other trials of Hydroxyurea

Trials testing the same drug.

Other recruiting trials for Sickle Cell Anemia

Currently open trials in the same condition.

Other Vanderbilt University Medical Center trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01801423.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing