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NCT02535208 · ClinicalTrials.gov registry record · NA
Combining Restrictive Guidelines and a NIRS SCORE to Decrease RBC Transfusions
A NA study, sponsored by NYU Langone Health.
- Completed
- Registry status
- NA
- Development phase
- 10
- Enrollment target
NCT02535208 is a NA study that has completed, run by NYU Langone Health. The registered enrollment target is 10 participants.
The verdict
NCT02535208, a NA study, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
Study Summary
The primary aim of this study is to determine the mean number of red blood cell (RBC) transfusions received by preterm infants cared for using restrictive Hgb guidelines in combination with splanchnic to cerebral oxygenation ratio (SCOR) assessment compared to the mean number of transfusions received by preterm infants cared for using liberal guidelines alone. This study is designed as a prospective randomized controlled trial. Preterm infants less than 30 weeks gestational age and 500-1250 grams in weight will be recruited and enrolled into the study during day of life 0 to 3. Study participants will be randomly assigned into two groups: a restrictive transfusion group and a liberal transfusion group. In the liberal group, RBC transfusions will be given to subjects when their Hgb level falls below defined values that are based on respiratory support status. In the restrictive group, RBC transfusions will be given to subjects either when their Hgb level falls below defined values based on respiratory status or, despite not having reached their Hgb trigger threshold, if they manifest symptoms judged by the clinical care team to be consistent with anemia (i.e. apnea, bradycardia, or desaturation episodes) and subsequently have a near-infrared spectroscopy (NIRS) evaluation that demonstrates an SCOR \< 0.73.
Interventions
- OTHER Restrictive transfusions based on SCOR assessment
- OTHER Liberal transfusions
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2016-05-16 |
| Est. Completion | 2018-10-03 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02535208
The ClinicalTrials.gov registry entry for NCT02535208 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Restrictive transfusions based on SCOR assessment is the first listed.
NCT02535208 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02535208 about?
NCT02535208 is a clinical study titled "Combining Restrictive Guidelines and a NIRS SCORE to Decrease RBC Transfusions". The primary aim of this study is to determine the mean number of red blood cell (RBC) transfusions received by preterm infants cared for using restrictive Hgb guidelines in combination with splanchnic to cerebral oxygenation ratio (SCOR) assessment compared to the mean number of transfusions receive...
What is the current status of trial NCT02535208?
This trial is currently completed. It is a NA study. The enrollment target is 10 participants. The study started on 2016-05-16. Estimated completion is 2018-10-03.
What interventions are being tested in trial NCT02535208?
The interventions under investigation include: Restrictive transfusions based on SCOR assessment (OTHER), Liberal transfusions (OTHER).
Who is sponsoring clinical trial NCT02535208?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
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