CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 196 enrolled
Drug / intervention
transfusion therapyprocedure
Likely dose
At least monthly blood transfusion therapyAI-extracted
Key inclusion· 3
  • Confirmed sickle cell anemia (hemoglobin SS) or sickle beta-thalassemia (hemoglobin S-beta) with diagnostic hemoglobin analysis documentation
  • Age 5 through 14 years
  • Cerebral infarct documented by MRI scan as confirmed by neuroradiology panel
Key exclusion· 12
  • History of overt stroke (focal neurologic event lasting >24 hours with documentation) or prior focal neurologic event with medical documentation
  • Transcranial doppler (TCD) time-averaged mean velocity >200 cm/sec verified by study radiologist
  • Other neurological disorders including neurofibromatosis, lead poisoning, or tuberous sclerosis
  • HIV infection

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00072761
NCT00072761Phase 3Completed

Silent Cerebral Infarct Transfusion Multi-Center Clinical Trial

Washington University School of Medicine·interventional·Posted Nov 13, 2003·Updated Feb 8, 2016

In Brief

A Phase 3 clinical trial evaluating transfusion therapy for Sickle Cell Anemia and Stroke. Completed, enrolled 196 participants across 1 site.

Detailed Summary

The goal of this study is to determine the effectiveness of blood transfusion therapy for prevention of silent cerebral infarct (stroke) in children with sickle cell anemia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 13, 2003
Enrollment StartDec 1, 2004
Primary CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 9 yearsPosted 22.6 years ago

Interventions

transfusion therapyprocedure

Those in the blood transfusion group will receive at least monthly blood transfusion therapy.