Trial Outcomes & Findings for Preventing Acute Chest Syndrome by Transfusion Feasibility Study (NCT NCT00951808)

NCT ID: NCT00951808

Last Updated: 2013-04-24

Results Overview

First occurence of positive infiltrate on chest x-ray

Recruitment status

COMPLETED

Study phase

Target enrollment

237 participants

Primary outcome timeframe

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.

Results posted on

2013-04-24

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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)).
Overall Study STARTED	4	6	227
Overall Study COMPLETED	4	6	223
Overall Study NOT COMPLETED	0	0	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Preventing Acute Chest Syndrome by Transfusion Feasibility Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=237 Participants 237 subjects enrolled in the feasibility study.
Age, Categorical <=18 years	122 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	114 Participants n=99 Participants
Age, Categorical >=65 years	1 Participants n=99 Participants
Sex: Female, Male Female	119 Participants n=99 Participants
Sex: Female, Male Male	118 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	230 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Race/Ethnicity, Customized White	3 participants n=99 Participants
Race/Ethnicity, Customized Black or African American	230 participants n=99 Participants
Race/Ethnicity, Customized More than one race	1 participants n=99 Participants
Race/Ethnicity, Customized Other	3 participants n=99 Participants
Maximum secretory phospholipase A2 (sPLA2) value >0 - 25 ng/ml	106 participants n=99 Participants
Maximum secretory phospholipase A2 (sPLA2) value >25 - 50 ng/ml	34 participants n=99 Participants
Maximum secretory phospholipase A2 (sPLA2) value >50 - 100 ng/ml	22 participants n=99 Participants
Maximum secretory phospholipase A2 (sPLA2) value >100 - 200 ng/ml	13 participants n=99 Participants
Maximum secretory phospholipase A2 (sPLA2) value >200 - 800 ng/ml	28 participants n=99 Participants
Maximum secretory phospholipase A2 (sPLA2) value Not applicable	34 participants n=99 Participants

PRIMARY outcome

Timeframe: 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.

Population: Of 237 enrolled subjects, 27 subjects who received a transfusion and 7 subjects who had insufficient sPLA2 measurements were excluded. Therefore, two hundred and three (203) subjects were included in the analysis. Results were not reported by Arm due to the lack of enrollment.

First occurence of positive infiltrate on chest x-ray

Outcome measures

Outcome measures
Measure	Adults n=96 Participants Age \>= 18	Children n=107 Participants Age \< 18	Overall n=203 Participants Both adults and children
Acute Chest Syndrome Yes	11 participants	11 participants	22 participants
Acute Chest Syndrome No	85 participants	96 participants	181 participants

Adverse Events

Blood Transfusion Trial Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Hae-Young Kim

New England Research Institutes

Phone: 617-972-3251

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place