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NCT00128713 · ClinicalTrials.gov registry record · Phase 3
Optimal Platelet Dose Strategy for Management of Thrombocytopenia
A Phase 3 study, sponsored by Carelon Research.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,351
- Enrollment target
NCT00128713: Completed Phase 3 study, sponsored by Carelon Research.
NCT00128713 is a Phase 3 study that has completed, run by Carelon Research. The registered enrollment target is 1,351 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (75% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00128713, a Phase 3 study, has completed, sponsored by Carelon Research.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,351 participants
- Enrollment target
Study Summary
The primary objective of this study is to compare the three study arms of lower, medium, and higher dose platelet therapy with respect to the percentage of patients experiencing at least one episode of Grade 2 or higher bleeding as determined by the Platelet Dose Trial Bleeding Scale (Grade 2 bleeding corresponds to bleeding that is moderate, but not severe enough to warrant red blood cell transfusion). There are a number of secondary endpoints related to platelet transfusions, hemostasis, and other concerns. The four most important secondary endpoints will compare the three study arms with respect to the following outcomes: 1) platelet utilization rates (total number of platelets transfused x 10 \^11); 2) number of platelet transfusion events (frequency of transfusions); a transfusion event would be defined as each separate platelet transfusion issued by the study site's transfusion service; 3) highest category of bleeding during time of study (Platelet Dose Trial Bleeding Scale Grades less than or equal to 1, 2, 3, or 4 by arm); and 4) bleeding severity based on number of days with bleeding (total days of bleeding and bleeding/thrombocytopenic day), intensity of bleeding, and number of sites with bleeding (if such a severity score has been validated and published by the time the study is completed).
Primary Outcome
Any Grade 2 (moderate) or higher grade bleeding, as determined by daily hemostatic assessment and documentation of any red blood cell transfusions to treat bleeding
Interventions
- PROCEDURE Medium Dose Prophylactic Platelet Transfusions
- PROCEDURE Lower Dose Prophylactic Platelet Transfusions
- PROCEDURE Higher Dose Prophylactic Platelet Transfusions
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,351 participants |
| Start Date | 2004-07 |
| Est. Completion | 2008-01 |
| Phase | Phase 3 |
What the finished NCT00128713 record still lists
NCT00128713 is an interventional study that assigns participants to a tested intervention. Its 1,351 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (75% higher).
The record links to 0 conditions, and to 3 interventions - of which Medium Dose Prophylactic Platelet Transfusions is the first listed.
NCT00128713 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00128713 about?
NCT00128713 is a clinical study titled "Optimal Platelet Dose Strategy for Management of Thrombocytopenia". The primary objective of this study is to compare the three study arms of lower, medium, and higher dose platelet therapy with respect to the percentage of patients experiencing at least one episode of Grade 2 or higher bleeding as determined by the Platelet Dose Trial Bleeding Scale (Grade 2 bleedi...
What is the current status of trial NCT00128713?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,351 participants. The study started on 2004-07. Estimated completion is 2008-01.
What interventions are being tested in trial NCT00128713?
The interventions under investigation include: Medium Dose Prophylactic Platelet Transfusions (PROCEDURE), Lower Dose Prophylactic Platelet Transfusions (PROCEDURE), Higher Dose Prophylactic Platelet Transfusions (PROCEDURE).
Who is sponsoring clinical trial NCT00128713?
This trial is sponsored by Carelon Research, which has 50 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00128713's enrollment target sits among peer trials
1,351 181st of 2000 higher than 1,820 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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