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Strategies for Transfusion of Platelets (SToP)

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ClinicalTrials.gov Identifier: NCT00420914
Recruitment Status : Terminated (Stopped at the request of the Data Safety Monitoring Board for safety reasons.)
First Posted : January 11, 2007
Last Update Posted : May 28, 2008
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Study Description
Brief Summary:
To evaluate the hemostatic efficacy of a low dose platelet transfusion strategy compared to a standard dose platelet transfusion strategy.

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

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Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
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"]
Study Start Date : October 2003

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Outcome Measures

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

Secondary Outcome Measures :
  1. Number of platelets transfused during a defined period of thrombocytopenia
  2. Number of platelet transfusion events(frequency)
  3. Number of platelets transfused and frequency per thrombocytopenic day
  4. Mean duration of thrombocytopenia
  5. Percentage of days at risk of bleeding
  6. Differences in the severity of bleeding between treatment groups
  7. Correlation between the actual platelet dose given per transfusion for each patient and bleeding on the day following transfusion
  8. 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
  9. Pre- and post-transfusion bleeding grade in response to the dose of therapeutic platelets transfused
  10. Surrogate outcomes for hemostatic efficacy including death due to bleeding as the primary and contributory cause of mortality
  11. Platelet transfusion given above trigger
  12. Platelet transfusion more often than once a day
  13. Platelet transfusion given above their assigned dose in each case because of >/= WHO Grade 2 bleeding
  14. Number of platelets transfused
  15. Frequency of transfusions and duration of transfusions given because of bleeding
  16. Total number of RBC transfusions
  17. The mean per thrombocytopenic day for each patient
  18. Platelet response (pre-transfusion platelet counts, post-transfusion platelet counts, platelet increments, and corrected platelet count increments (at 1 and/or 24 hours)
  19. Cost analysis.

Eligibility Criteria

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

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

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
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
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 Posted: January 11, 2007    Key Record Dates
Last Update Posted: May 28, 2008
Last Verified: May 2008

Keywords provided by McMaster University:

Additional relevant MeSH terms:
Blood Platelet Disorders
Hematologic Diseases