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Strategies for Transfusion of Platelets (SToP)

This study has been terminated.
(Stopped at the request of the Data Safety Monitoring Board for safety reasons.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00420914
First Posted: January 11, 2007
Last Update Posted: May 28, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Dartmouth-Hitchcock Medical Center
Haukeland University Hospital
Ottawa Hospital Research Institute
Cedars-Sinai Medical Center
University Health Network, Toronto
Information provided by:
McMaster University
  Purpose
To evaluate the hemostatic efficacy of a low dose platelet transfusion strategy compared to a standard dose platelet transfusion strategy.

Condition Intervention Phase
Thrombocytopenia Procedure: low dose of 2.25 x 10^11 platelets/transfusion (range 1.5 to 2.9) Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Health Services Research
Official Title: Strategies for Transfusion of Platelets (SToP) [Formerly Titled "Evaluation of the Hemostatic Efficacy and Platelet Utilization Rates of Low Versus Standard Dose Platelet Therapy"]

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Daily hemostatic assessments will be conducted to determine presence of WHO Grade 2 bleeding or greater.

Secondary Outcome Measures:
  • Number of platelets transfused during a defined period of thrombocytopenia
  • Number of platelet transfusion events(frequency)
  • Number of platelets transfused and frequency per thrombocytopenic day
  • Mean duration of thrombocytopenia
  • Percentage of days at risk of bleeding
  • Differences in the severity of bleeding between treatment groups
  • Correlation between the actual platelet dose given per transfusion for each patient and bleeding on the day following transfusion
  • Correlation between the actual number between the actual number of platelets transfused/kg body weight for each patient and bleeding on the day following transfusion
  • Pre- and post-transfusion bleeding grade in response to the dose of therapeutic platelets transfused
  • Surrogate outcomes for hemostatic efficacy including death due to bleeding as the primary and contributory cause of mortality
  • Platelet transfusion given above trigger
  • Platelet transfusion more often than once a day
  • Platelet transfusion given above their assigned dose in each case because of >/= WHO Grade 2 bleeding
  • Number of platelets transfused
  • Frequency of transfusions and duration of transfusions given because of bleeding
  • Total number of RBC transfusions
  • The mean per thrombocytopenic day for each patient
  • Platelet response (pre-transfusion platelet counts, post-transfusion platelet counts, platelet increments, and corrected platelet count increments (at 1 and/or 24 hours)
  • Cost analysis.

Enrollment: 130
Study Start Date: October 2003
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   17 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with hypoproliferative thrombocytopenia who are expected to have a platelet count of ≤ 10,000/µL (10x10^9/L) for ≥ 10 days (Note: the prophylactic platelet trigger may be higher than10,000/µL (10x10^9/L) in some participating institutions; however, the patient will still be eligible for participation as long as they are expected to be thrombocytopenic for 10 days)
  • Must be an inpatient.
  • Weight between 40 and 100 kg.

Exclusion Criteria:

  • Diagnosis of promyelocytic leukemia.
  • A history or current diagnosis of immune thrombocytopenia (ITP), thrombotic thrombocytopenia (TTP), or hemolytic uremia syndrome (HUS).
  • Evidence of ≥ WHO Grade 2 bleeding while being assessed for the study entry.
  • Patients who will receive bedside Leukoreduced platelet transfusions.
  • Patients who are pregnant.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00420914


Locations
United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Canada, Ontario
McMaster University
Hamilton, Ontario, Canada, L8N3Z5
Ottawa Health Research Institute
Ottawa, Ontario, Canada, K1H 8L6
University Health Network
Toronto, Ontario, Canada, M5G2M9
Norway
Haukeland University Hospital
Bergen, Norway
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Dartmouth-Hitchcock Medical Center
Haukeland University Hospital
Ottawa Hospital Research Institute
Cedars-Sinai Medical Center
University Health Network, Toronto
Investigators
Principal Investigator: Nancy M Heddle, MSc., FCSMLS(D) McMaster University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00420914     History of Changes
Other Study ID Numbers: SToP Study
First Submitted: January 8, 2007
First Posted: January 11, 2007
Last Update Posted: May 28, 2008
Last Verified: May 2008

Keywords provided by McMaster University:
Thrombocytopenia
Platelets
Dose
Bleeding

Additional relevant MeSH terms:
Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases