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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 is a Phase 3 study that has completed, run by Carelon Research. The registered enrollment target is 1,351 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00128713
The ClinicalTrials.gov registry entry for NCT00128713 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,351 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Carelon Research, which has 50 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Medium Dose Prophylactic Platelet Transfusions is the first listed.
NCT00128713 reports 0 study locations.
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.
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