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Clinical trialNCT00128713CompletedPhase 3Interventional

Optimal Platelet Dose Strategy for Management of Thrombocytopenia

SponsorCarelon ResearchEnrollment1,351Thrombocytopenia
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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).

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

21 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Emory University Hospitals; Children'S Healthcare of Atlanta

    Atlanta, Georgia, United States

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, United States

  • Tulane University Hospital and Clinics

    New Orleans, Louisiana, United States

  • Johns Hopkins Hospital

    Baltimore, Maryland, United States

  • University of Maryland Medical Center

    Baltimore, Maryland, United States

  • Children'S Hospital Boston; Beth Israel Deaconess Medical Center; Brigham and Women'S Hospital

    Boston, Massachusetts, United States

  • University of Minnesota Medical Center, Fairview

    Minneapolis, Minnesota, United States

  • Ny-Presbyterian Hosp/weill Cornell Medical Center

    New York, New York, United States

  • University of North Carolina Hospitals

    Chapel Hill, North Carolina, United States

  • Duke University Medical Center

    Durham, North Carolina, United States

  • University Hospital Cleveland

    Cleveland, Ohio, United States

  • U of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, United States

  • U of Pennsylvania Health System; Children'S Hospital of Philadelphia

    Philadelphia, Pennsylvania, United States

  • University of Pittsburgh Presbyterian and Shadyside Hospital

    Pittsburgh, Pennsylvania, United States

  • U of Texas Sw Medical Center at Dallas

    Dallas, Texas, United States

  • U of Washington Medical Center/fhcrc; Children'S Hospital and Medical Center

    Seattle, Washington, United States

  • Virginia Mason Hospital

    Seattle, Washington, United States

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin, United States

  • Children'S Hospital of Wisconsin

    Milwaukee, Wisconsin, United States

  • Froedtert Memorial Lutheran Hospital

    Milwaukee, Wisconsin, United States

  • Oncology Alliance/st. Luke'S Hospital

    Milwaukee, Wisconsin, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
31 Jul 2004
Primary completion
31 Jan 2008
Completion
31 Jan 2008
Last update posted
28 Oct 2015
Registered enrollment
1,351
Registry id
NCT00128713

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.