Trial Outcomes & Findings for Abbott ESA Chagas Assay Post-Market Study (NCT NCT01662362)

NCT ID: NCT01662362

Last Updated: 2014-02-20

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 63 participants
• Primary outcome timeframe: Up to six months
• Results posted on: 2014-02-20

Participant Flow

Participant milestones

Measure	Testing Donor Specimens With ESA Chagas Test blood donor specimens that are ABBOTT PRISM Chagas Repeatedly Reactive with ESA Chagas. Donors will be asked to return for a follow-up blood draw. Testing Donor Specimens with ESA Chagas: Donors will be asked to return for a follow-up blood draw.
Overall Study STARTED	63
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	38

Reasons for withdrawal

Measure	Testing Donor Specimens With ESA Chagas Test blood donor specimens that are ABBOTT PRISM Chagas Repeatedly Reactive with ESA Chagas. Donors will be asked to return for a follow-up blood draw. Testing Donor Specimens with ESA Chagas: Donors will be asked to return for a follow-up blood draw.
Overall Study Lost to Follow-up	38

Baseline Characteristics

Abbott ESA Chagas Assay Post-Market Study

Baseline characteristics by cohort

Measure	Testing Donor Specimens With ESA Chagas n=63 Participants Test blood donor specimens that are ABBOTT PRISM Chagas Repeatedly Reactive with ESA Chagas. Donors will be asked to return for a follow-up blood draw. Testing Donor Specimens with ESA Chagas: Donors will be asked to return for a follow-up blood draw.
Age, Customized >= 18 years	19 participants n=5 Participants
Age, Customized Unknown	44 participants n=5 Participants
Sex/Gender, Customized Male	9 participants n=5 Participants
Sex/Gender, Customized Female	10 participants n=5 Participants
Sex/Gender, Customized Unknown	44 participants n=5 Participants
Region of Enrollment United States	63 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to six months

Outcome measures

Measure	Testing Donor Specimens With ESA Chagas n=63 Participants Test blood donor specimens that are ABBOTT PRISM Chagas Repeatedly Reactive with ESA Chagas. Donors will be asked to return for a follow-up blood draw. Testing Donor Specimens with ESA Chagas: Donors will be asked to return for a follow-up blood draw.
ESA Chagas Testing of US Blood Donor Specimens Repeatedly Reactive by ABBOTT PRISM Chagas	92.06 percent agreement to RIPA Interval 82.44 to 97.37

SECONDARY outcome

Timeframe: Up to six months

Outcome measures

Measure	Testing Donor Specimens With ESA Chagas n=300 Participants Test blood donor specimens that are ABBOTT PRISM Chagas Repeatedly Reactive with ESA Chagas. Donors will be asked to return for a follow-up blood draw. Testing Donor Specimens with ESA Chagas: Donors will be asked to return for a follow-up blood draw.
ESA Testing of Preselected Donor Specimens Nonreactive by ABBOTT PRISM Chagas	99.00 percentage of specimens ESA negative Interval 97.11 to 99.79

Adverse Events

Testing Donor Specimens With ESA Chagas

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

Barbara Kaesdorf, Associate Director Clinical Affairs

Abbott

Phone: 847-937-8702

Email: barbara.kaesdorf@abbott.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60