Preventing Acute Chest Syndrome by Transfusion Feasibility Study (PROACTIVE)

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. Identifier: NCT00951808
Recruitment Status : Completed
First Posted : August 4, 2009
Results First Posted : April 5, 2013
Last Update Posted : April 24, 2013
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
New England Research Institutes

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Sickle Cell Disease
Interventions: Biological: Single blood transfusion
Behavioral: Standard care

  Participant Flow

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
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

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
All Participants 237 subjects enrolled in the feasibility study.

Baseline Measures
   All Participants 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   122 
Between 18 and 65 years   114 
>=65 years   1 
[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

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

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

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: New England Research Institutes Identifier: NCT00951808     History of Changes
Other Study ID Numbers: 668
U10HL083721 ( U.S. NIH Grant/Contract )
First Submitted: July 31, 2009
First Posted: August 4, 2009
Results First Submitted: April 25, 2012
Results First Posted: April 5, 2013
Last Update Posted: April 24, 2013