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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:
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
ClinicalTrials.gov Identifier:
NCT00420914
First received: January 8, 2007
Last updated: May 27, 2008
Last verified: May 2008
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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:

U.S. FDA Resources

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

Ages Eligible for Study:   17 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by McMaster University

Additional 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
Study First Received: January 8, 2007
Last Updated: May 27, 2008
Health Authority: Canada: Ethics Review Committee

Keywords provided by McMaster University:
Thrombocytopenia
Platelets
Dose
Bleeding

Additional relevant MeSH terms:
Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases

ClinicalTrials.gov processed this record on May 16, 2013