Preventing Acute Chest Syndrome by Transfusion Feasibility Study (PROACTIVE)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
New England Research Institutes
ClinicalTrials.gov Identifier:
NCT00951808
First received: July 31, 2009
Last updated: April 16, 2013
Last verified: April 2013
Results First Received: April 25, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Sickle Cell Disease
Interventions: Biological: Single blood transfusion
Behavioral: Standard care

  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
In the period June 2009 - June 2010, 237 subjects from 25 sites were enrolled in the feasibility study. Of 237 enrolled, only 10 were randomized (six subjects in the Standard Care Arm and four subjects in the Transfusion Arm). The randomization trial has been terminated due to the lack of enrollment.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Blood Transfusion Trial Cohort Subjects received a transfusion within 6 hours of randomization.
Standard Care Trial Cohort Subjects received standard care (regular care for acute chest syndrome (ACS)) without a clinically indicated transfusion.
Standard Care Observational Cohort Subjects who are ineligible for or who decline the blood transfusion part of the study participated in the observational portion of the study and received standard care (regular care for acute chest syndrome (ACS)).

Participant Flow:   Overall Study
    Blood Transfusion Trial Cohort     Standard Care Trial Cohort     Standard Care Observational Cohort  
STARTED     4     6     227  
COMPLETED     4     6     223 [1]
NOT COMPLETED     0     0     4  
[1] Four subjects withdrew from the study.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The randomization trial has been terminated due to the lack of enrollment. Therefore, the results were not reported by Arm and the total number of subjects (237) enrolled in the feasibility study was used.

Reporting Groups
  Description
All Participants 237 subjects enrolled in the feasibility study.

Baseline Measures
    All Participants  
Number of Participants  
[units: participants]
  237  
Age  
[units: participants]
 
<=18 years     122  
Between 18 and 65 years     114  
>=65 years     1  
Gender  
[units: participants]
 
Female     119  
Male     118  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     7  
Not Hispanic or Latino     230  
Unknown or Not Reported     0  
Race/Ethnicity, Customized  
[units: participants]
 
White     3  
Black or African American     230  
More than one race     1  
Other     3  
Maximum secretory phospholipase A2 (sPLA2) value [1]
[units: participants]
 
>0 - 25 ng/ml     106  
>25 - 50 ng/ml     34  
>50 - 100 ng/ml     22  
>100 - 200 ng/ml     13  
>200 - 800 ng/ml     28  
Not applicable     34  
[1] Maximum secretory phospholipase A2 (sPLA2) value measured prior to acute chest syndrome (ACS) or discharge



  Outcome Measures

1.  Primary:   Acute Chest Syndrome   [ Time Frame: Chest x-rays (CXR) were ordered for trial eligibility, as a result of clinical indications, or at discharge or 72 hours if no prior CXR. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
The feasibility study has been completed, but the randomization trial has been terminated early due to the lack of enrollment. Therefore, the results were reported with the subjects who completed the feasibility study and were not reported by Arm.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Hae-Young Kim
Organization: New England Research Institutes
phone: 617-972-3251
e-mail: hkim@nerisicence.com


Publications of Results:
Publications automatically indexed to this study:

Responsible Party: New England Research Institutes
ClinicalTrials.gov Identifier: NCT00951808     History of Changes
Other Study ID Numbers: 668, U10HL083721
Study First Received: July 31, 2009
Results First Received: April 25, 2012
Last Updated: April 16, 2013
Health Authority: United States: Federal Government