N/A
N=3,443
IMPACT (Improving Plasma Collection) Clinical Trial
Apheresis Related Hypotension
Bottom Line
View on ClinicalTrials.gov: NCT04320823 ↗Enrolled (actual)
3,443
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcome: Primary: Rate of Significant Hypotensive Adverse Events — .035; .051 % of significant hypotensive AEs
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Updated Plasma Collection Feature (Device); Current Plasma Collection Approach (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Haemonetics Corporation
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Significant Hypotensive Adverse Events |
.035; .051 | — |
| SECONDARY Rate of Severe Hypotensive Adverse Events |
1; 1 | — |
| SECONDARY Rate of Significant Hypotensive Adverse Events Relative to Volume |
4.27; 6.65 | — |
| SECONDARY Time From Start of Collection to First Significant Hypotensive Adverse Event |
30.41; 51.59 | — |
| SECONDARY Rate of Significant Hypotensive Adverse Events Relative to Bodyweight |
0; 0; .036; .052 | — |
| SECONDARY Rate of Significant Hypotensive Adverse Events Relative to BMI |
.043; .020; .03; .074 | — |
| SECONDARY Rate of Significant Hypotensive Adverse Events Relative to Donor Status |
0; .247; .037; .044 | — |
| SECONDARY Rate of Significant Hypotensive Adverse Events Relative to Gender |
.048; .07; .028; .040 | — |
| SECONDARY Total Volume |
841.69; 777.84 | — |
Summary
Prospective, multi-center, randomized, controlled clinical trial to study the safety and effectiveness of a novel plasma collection system software.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04320823). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.