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NCT01531387 · ClinicalTrials.gov registry record · Phase 3
Sparing Conversion to Abnormal TCD (Transcranial Doppler) Elevation (SCATE)
A Phase 3 study, sponsored by Children's Hospital Medical Center, Cincinnati.
- Terminated
- Registry status
- Phase 3
- Development phase
- 38
- Enrollment target
NCT01531387: Clinical Trial Phase 3 study, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT01531387 is a Phase 3 study that was terminated before completion, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 38 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01531387, a Phase 3 study, was terminated before completion, sponsored by Children's Hospital Medical Center, Cincinnati.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 38 participants
- Enrollment target
Study Summary
The primary goal of the Phase III SCATE trial is to compare 30 months of alternative therapy (hydroxyurea) to standard care (observation) in children with sickle cell anemia and conditional (170 - 199cm/sec) Transcranial Doppler (TCD) velocities. For the alternative regimen (hydroxyurea) to be declared superior to the standard treatment regimen (observation), the hydroxyurea-treated group must have a three-fold reduction in the incidence of conversion to abnormal TCD velocities (≥ 200 cm/sec), compared to the standard treatment arm.
Primary Outcome
The primary endpoint of the SCATE trial is the cumulative incidence of conversion to abnormal maximum TAMV (time-averaged mean velocity) measured by transcranial doppler (TCD) ultrasonography. Subjects must have conditional velocities at baseline, defined as 170 - 199 cm/sec, which indicate moderate stroke risk. Abnormal velocities are defined as ≥ 200 cm/sec, which indicate high stroke risk. The number of conversions from conditional velocities to abnormal velocities in each treatment arm will
Interventions
- DRUG Hydroxyurea
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2012-05 |
| Est. Completion | 2014-01 |
| Phase | Phase 3 |
Why NCT01531387 stopped before completion
NCT01531387 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which Hydroxyurea is the first listed.
NCT01531387 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01531387 about?
NCT01531387 is a clinical study titled "Sparing Conversion to Abnormal TCD (Transcranial Doppler) Elevation (SCATE)". The primary goal of the Phase III SCATE trial is to compare 30 months of alternative therapy (hydroxyurea) to standard care (observation) in children with sickle cell anemia and conditional (170 - 199cm/sec) Transcranial Doppler (TCD) velocities. For the alternative regimen (hydroxyurea) to be decla...
What is the current status of trial NCT01531387?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 38 participants. The study started on 2012-05. Estimated completion is 2014-01.
What interventions are being tested in trial NCT01531387?
The interventions under investigation include: Hydroxyurea (DRUG).
Who is sponsoring clinical trial NCT01531387?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01531387's enrollment target sits among peer trials
38 1900th of 2000 higher than 100 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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