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Optimal Platelet Dose Strategy for Management of Thrombocytopenia (PLADO)

This study has been completed.
Sponsor:
Collaborator:
Transfusion Medicine/Hemostasis Clinical Research Network
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00128713
First received: August 8, 2005
Last updated: December 18, 2009
Last verified: December 2009
History of Changes
Results First Received: January 30, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Thrombocytopenia
Interventions: Procedure: Medium Dose Prophylactic Platelet Transfusions
Procedure: Lower Dose Prophylactic Platelet Transfusions
Procedure: Higher Dose Prophylactic Platelet Transfusions

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Lower Dose Platelets Lower Dose Prophylactic Platelets (1.1 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
Medium Dose Platelets Medium Dose Prophylactic Platelets (2.2 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
Higher Dose Platelets Higher Dose Prophylactic Platelets (4.4 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)

Participant Flow:   Overall Study
    Lower Dose Platelets     Medium Dose Platelets     Higher Dose Platelets  
STARTED     453     449     449  
COMPLETED     453     449     449  
NOT COMPLETED     0     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
Lower Dose Platelets Lower Dose Prophylactic Platelets (1.1 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
Medium Dose Platelets Medium Dose Prophylactic Platelets (2.2 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
Higher Dose Platelets Higher Dose Prophylactic Platelets (4.4 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
Total Total of all reporting groups

Baseline Measures
    Lower Dose Platelets     Medium Dose Platelets     Higher Dose Platelets     Total  
Number of Participants  
[units: participants]
 		  453     449     449     1351  
Age  
[units: years]
Mean ± Standard Deviation 		  43.5  ± 19.3     44.7  ± 19.3     45.5  ± 19.7     44.6  ± 19.4  
Age, Customized  
[units: participants]
 		       
0 - 17 years     67     68     64     199  
18 - 20 years     9     6     8     23  
>=21 years     377     374     377     1128  
Unknown/not reported     0     1     0     1  
Gender, Customized  
[units: participants]
 		       
Female     189     176     169     534  
Male     264     272     280     816  
Unknown/not reported     0     1     0     1  
Race (NIH/OMB)  
[units: participant]
 		       
American Indian or Alaska Native     4     1     3     8  
Asian     7     8     4     19  
Native Hawaiian or Other Pacific Islander     2     0     0     2  
Black or African American     53     37     40     130  
White     362     374     378     1114  
More than one race     13     9     10     32  
Unknown or Not Reported     12     20     14     46  
Ethnicity (NIH/OMB)  
[units: participant]
 		       
Hispanic or Latino     18     19     21     58  
Not Hispanic or Latino     433     425     423     1281  
Unknown or Not Reported     2     5     5     12  
Region of Enrollment  
[units: participants]
 		       
United States     453     449     449     1351  
Treatment Regimen  
[units: Participants]
 		       
Autologous or syngeneic stem cell transplant     154     149     151     454  
Allogeneic stem cell transplant     185     185     186     556  
Chemotherapy for hematologic malignancy     111     112     110     333  
Chemotherapy for solid tumor     3     3     2     8  
Body Surface Area  
[units: m^2]
Mean ± Standard Deviation 		  1.8  ± 0.4     1.8  ± 0.4     1.8  ± 0.4     1.8  ± 0.4  
Height  
[units: cm]
Mean ± Standard Deviation 		  165.5  ± 21.4     164.0  ± 21.7     166.2  ± 19.3     165.2  ± 20.8  
Weight  
[units: kg]
Mean ± Standard Deviation 		  77.4  ± 24.9     75.0  ± 26.3     76.0  ± 23.8     76.1  ± 25.0  



  Outcome Measures
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1.  Primary:   At Least One Day With Grade 2 or Higher Bleeding   [ Time Frame: From randomization until the subject ends the study (10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or hospital discharge, whichever occurs first) ]
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2.  Secondary:   Platelet Utilization   [ Time Frame: From randomization until the subject ends the study (10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or hospital discharge, whichever occurs first) ]
  Show Outcome Measure 2

3.  Secondary:   Number of Platelet Transfusion Episodes   [ Time Frame: From randomization until the subject ends the study (10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or hospital discharge, whichever occurs first) ]
  Show Outcome Measure 3

4.  Secondary:   Bleeding Severity, if a Suitable Scale is Validated and Published by the Time the Trial Ends   [ Time Frame: From randomization until the subject ends the study (10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or hospital discharge, whichever occurs first) ]
  Show Outcome Measure 4

5.  Secondary:   Highest Grade of Bleeding While on Study   [ Time Frame: From randomization until the subject ends the study (10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or hospital discharge, whichever occurs first) ]
  Show Outcome Measure 5


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: Susan Assmann, PhD
Organization: New England Research Institutes
phone: 617-923-7747 ext 548
e-mail: sassmann@neriscience.com


No publications provided by National Heart, Lung, and Blood Institute (NHLBI)

Publications automatically indexed to this study:


Responsible Party: Susan F. Assmann, New England Research Institutes
ClinicalTrials.gov Identifier: NCT00128713     History of Changes
Other Study ID Numbers: 238, U01 HL072268, U01 HL72028, U01 HL72033, U01 HL72072, U01 HL72191, U01 HL72196, U01 HL72248, U01 HL72274, U01 HL72283, U01 HL72289, U01 HL72290, U01 HL72291, U01 HL72305, U01 HL72331, U01 HL72346, U01 HL72355, U01 HL72359
Study First Received: August 8, 2005
Results First Received: January 30, 2009
Last Updated: December 18, 2009
Health Authority: United States: Federal Government