Status:
COMPLETED
IMPACT (Improving Plasma Collection) Clinical Trial
Lead Sponsor:
Haemonetics Corporation
Conditions:
Apheresis Related Hypotension
Eligibility:
All Genders
18-66 years
Phase:
NA
Brief Summary
Prospective, multi-center, randomized, controlled clinical trial to study the safety and effectiveness of a novel plasma collection system software.
Detailed Description
Prospective, multi-center, randomized, controlled clinical trial that will be conducted at three source plasma collection centers throughout the United States. The objective of the trial is to study t...
Eligibility Criteria
Inclusion
- Donors must be qualified to donate plasma per individual site's screening procedures which are in compliance with IQPP standards. If donors do not meet inclusion criteria at subsequent donations but have already been enrolled in the clinical trial, they are eligible to remain in the clinical trial and to donate plasma within the clinical trial once they meet eligibility criteria again, except if they fulfill any of the exclusion criteria listed below.
Exclusion
- All subjects meeting any of the exclusion criteria listed below will be permanently excluded from the clinical trial.
- Subject not able or willing to give consent to participate in the clinical trial.
- Subject donated plasma outside of the present clinical trial after enrolling in this clinical trial.
- Subjects are withdrawn from the clinical trial due to safety concerns by the qualified healthcare providers.
- In addition, all donors for whom a BMI for use in the PPN feature cannot be reliably calculated will be excluded
Key Trial Info
Start Date :
January 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 27 2020
Estimated Enrollment :
3443 Patients enrolled
Trial Details
Trial ID
NCT04320823
Start Date
January 6 2020
End Date
April 27 2020
Last Update
April 9 2021
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Octapharma Plasma
Wichita, Kansas, United States, 67214
2
Octapharma Plasma
Charlotte, North Carolina, United States, 28217
3
Octapharma Plasma
Spokane, Washington, United States, 99208