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NCT01736657 · ClinicalTrials.gov registry record · NA
Evaluation of Spectra Optia Red Blood Cell Exchange in Sickle Cell Patients
A NA study, sponsored by Terumo BCT.
- Completed
- Registry status
- NA
- Development phase
- 73
- Enrollment target
NCT01736657: Completed NA study, sponsored by Terumo BCT.
NCT01736657 is a NA study that has completed, run by Terumo BCT. The registered enrollment target is 73 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01736657, a NA study, has completed, sponsored by Terumo BCT.
- COMPLETED
- Registry status
- NA
- Development phase
- 73 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the performance of the Spectra Optia system red blood cell exchange (RBCx) protocols (exchange and depletion/exchange) in study participants with sickle cell disease.
Primary Outcome
The primary endpoint evaluated the mean ratio of the Actual Fraction of Cells Remaining (FCRa: as measured by Post-Procedure % HbS) to the Predicted Fraction of Cells Remaining (FCRp: as predicted by the Spectra Optia system FCR algorithm multiplied by the Pre-Procedure % HbS), in the evaluable population (60 pts). The pre-defined range for the mean ratio of the FCRa to the FCRp was 0.75 to 1.25.
Interventions
- DEVICE Red blood cell exchange in sickle cell
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 73 participants |
| Start Date | 2012-11 |
| Est. Completion | 2013-06 |
| Phase | NA |
What the finished NCT01736657 record still lists
NCT01736657 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 73 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which Red blood cell exchange in sickle cell is the first listed.
NCT01736657 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01736657 about?
NCT01736657 is a clinical study titled "Evaluation of Spectra Optia Red Blood Cell Exchange in Sickle Cell Patients". The purpose of this study is to evaluate the performance of the Spectra Optia system red blood cell exchange (RBCx) protocols (exchange and depletion/exchange) in study participants with sickle cell disease.
What is the current status of trial NCT01736657?
This trial is currently completed. It is a NA study. The enrollment target is 73 participants. The study started on 2012-11. Estimated completion is 2013-06.
What interventions are being tested in trial NCT01736657?
The interventions under investigation include: Red blood cell exchange in sickle cell (DEVICE).
Who is sponsoring clinical trial NCT01736657?
This trial is sponsored by Terumo BCT, which has 12 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01736657's enrollment target sits among peer trials
73 1089th of 2000 higher than 912 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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