Optimal Platelet Dose Strategy for Management of Thrombocytopenia
Public ClinicalTrials.gov record NCT00128713. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Determination of the Optimal Prophylactic Platelet Dose Strategy to Prevent Bleeding in Thrombocytopenic Patients (A TMH CTN Study)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT00128713
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,351 participants
Conditions and interventions
Conditions
Interventions
- Medium Dose Prophylactic Platelet Transfusions Procedure
- Lower Dose Prophylactic Platelet Transfusions Procedure
- Higher Dose Prophylactic Platelet Transfusions Procedure
Procedure
Eligibility (public fields only)
- Age range
- Up to 100 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 2004 (Type not available)
- Primary completion
- Jan 2008 (Actual)
- Completion
- Jan 2008 (Actual)
- Last update posted
- Oct 28, 2015
2004 – 2008
United States locations
- U.S. sites
- 21
- U.S. states
- 14
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Emory University Hospitals; Children's Healthcare of Atlanta | Atlanta | Georgia | 30322 | — |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | — |
| Tulane University Hospital and Clinics | New Orleans | Louisiana | 70112 | — |
| University of Maryland Medical Center | Baltimore | Maryland | 21201 | — |
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | — |
| Children's Hospital Boston; Beth Israel Deaconess Medical Center; Brigham and Women's Hospital Brigham and Women's Hospital | Boston | Massachusetts | 02115 | — |
| University of Minnesota Medical Center, Fairview | Minneapolis | Minnesota | 55455 | — |
| NY-Presbyterian Hosp/Weill Cornell Medical Center | New York | New York | 10021 | — |
| University of North Carolina Hospitals | Chapel Hill | North Carolina | 27514 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| University Hospital Cleveland | Cleveland | Ohio | 44106 | — |
| U of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | — |
| U of Pennsylvania Health System; Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| University of Pittsburgh Presbyterian and Shadyside Hospital | Pittsburgh | Pennsylvania | 15213 | — |
| U of Texas SW Medical Center at Dallas | Dallas | Texas | 75390 | — |
| Virginia Mason Hospital | Seattle | Washington | 98101 | — |
| U of Washington Medical Center/FHCRC; Children's Hospital and Medical Center | Seattle | Washington | 98104 | — |
| University of Wisconsin Hospital and Clinics | Madison | Wisconsin | 53201 | — |
| Children's Hospital of Wisconsin | Milwaukee | Wisconsin | 53201 | — |
| Oncology Alliance/St. Luke's Hospital | Milwaukee | Wisconsin | 53215 | — |
| Froedtert Memorial Lutheran Hospital | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00128713, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 28, 2015 · Synced Oct 25, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00128713 live on ClinicalTrials.gov.