Apheresis Related HypotensionIMPACTNCT04320823

IMPACT (Improving Plasma Collection) Clinical Trial

A study testing Updated Plasma Collection Feature and Current Plasma Collection Approach in people with Apheresis Related Hypotension, run by Haemonetics Corporation at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Prospective, multi-center, randomized, controlled clinical trial to study the safety and effectiveness of a novel plasma collection system software. Read more about this study

Who is it for?: Ages 18 to 66 yearsHealthy volunteers can take part
Conditions the study is for: Apheresis Related Hypotension
What is being tested?: Updated Plasma Collection Feature and Current Plasma Collection Approach
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 3,443 participants
Where: 3 sitesUnited States
Study dates: 6 Jan 2020to 27 Apr 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 66 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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Subjects are withdrawn from the clinical trial due to safety concerns by the qualified healthcare providers.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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Octapharma Plasma
Charlotte, North Carolina, 28217
Octapharma Plasma
Spokane, Washington, 99208
Octapharma Plasma
Wichita, Kansas, 67214

Other trials in United States

About this study

Official title: Prospective, Randomized, Controlled, Multicenter Clinical Trial to Demonstrate the Safety and Effectiveness of the NexSys® PCS Plasma Collection System With the Percent Plasma Nomogram (PPN) Feature

Prospective, multi-center, randomized, controlled clinical trial to study the safety and effectiveness of a novel plasma collection system software.

Read the 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 the safety and effectiveness of a novel plasma collection nomogram run on the bi-directionally integrated Haemonetics NexSys PCS® and Haemonetics NexLynk DMS® plasma collection system. Subjects will be randomized into an intervention and control arm. The control arm will donate plasma using the current software. The intervention arm will donate plasma using a novel software that supports a more individualized collection approach.

Conditions: Apheresis Related Hypotension
Being tested: Updated Plasma Collection Feature, Current Plasma Collection Approach
Keywords: Plasmapheresis (Source plasma collection)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Updated Plasma Collection FeatureDevice
Plasma collection using a novel, patented system that supports a more individualized collection approach.
Current Plasma Collection ApproachDevice
Plasma collection using the current collection approach.

Study groups in NCT04320823
Study group	Role	What they receive
Experimental Group	Experimental	Plasma collection using a modified version (version 1.3.90) of NexSys PCS embedded software installed on current FDA-cleared NexSys PCS device hardware (PCS-300-US), with the new plasma collection feature enabled. Receives: Device: Updated Plasma Collection Feature
Control Group	Active comparator	Plasma collection using a modified version (version 1.3.90) of NexSys® PCS embedded software installed on current FDA-cleared NexSy PCS device hardware (PCS-300-US), with the new plasma collection feature disabled. Receives: Device: Current Plasma Collection Approach

What is being measured

The primary outcome is the main question the study is designed to answer.

Rate of Significant Hypotensive Adverse Events
The incidence rate of at least one significant hypotensive (vasovagal/hypovolemia) adverse event according to the plasma center adverse event reporting system, based on IQPP definitions of Signs/Symptoms/Findings.
Significant adverse events are defined as such events that fulfill the Signs/Symptoms/Findings of IQPP Donor Adverse Events (DAE) classifications 1.2 through 1.6 per the modified, symptoms-based approach following the plasma center adverse event reporting system.
A Model Based Prediction method was used for this outcome.
Measured: Up to approximately 3 months (total trial duration during which donors could donate), depending on time of enrollment into the trial.

Secondary outcomes (8)

Rate of Severe Hypotensive Adverse Events
Incidence rate of severe hypotensive (vasovagal/hypovolemia) adverse events according to the plasma center adverse event reporting system, based on the IQPP definitions of Signs/Symptoms/Findings, per donation in donors undergoing plasmapheresis.
*Only two severe (1.5) adverse events were observed: one in the experimental group and one in the control group. As the secondary analysis for severe hypotensive adverse events was to be conducted only if there were more than 2 severe hypotensive (vasovagal/hypovolemia) adverse events in any of the two study groups, no formal statistical analysis was performed.
Measured: Up to approximately 3 months, depending on time of enrollment into the trial.
Rate of Significant Hypotensive Adverse Events Relative to Volume
Incidence rate of significant hypotensive (vasovagal/hypovolemia) adverse events according to the plasma center adverse event reporting system, based on the IQPP definitions of Signs/Symptoms/Findings, relative to the actual plasma volume collected.
*The outcome is reported as the expected number of significant hypotensive adverse events per 10,000 L of collected plasma. This outcome was calculated using the total number of significant hypotensive adverse events and the total amount of plasma collected, then normalized to 10,000 L of collected plasma.
Measured: Up to approximately 3 months, depending on time of enrollment into the trial.
Time From Start of Collection to First Significant Hypotensive Adverse Event
Time from start of plasmapheresis "Begin Draw" to the first significant hypotensive (vasovagal/hypovolemia) adverse event according to the plasma center adverse event reporting system, based on the IQPP definitions of Signs/Symptoms/Findings.
Measured: Up to approximately 3 months, depending on time of enrollment into the trial.
Rate of Significant Hypotensive Adverse Events Relative to Bodyweight
Incidence rate of significant hypotensive (vasovagal/hypovolemia) adverse events according to the plasma center adverse event reporting system, based on the IQPP definitions of Signs/Symptoms/Findings, in the subgroups of donors with a bodyweight of less than or equal to 130 lbs and those greater than 130 lbs.
*Note: Due to the absence of AE in the subgroup of donors with bodyweight of ≤130 lbs, no formal statistical analysis was performed.
Measured: Up to approximately 3 months, depending on time of enrollment into the trial.
Rate of Significant Hypotensive Adverse Events Relative to BMI
Incidence rate of significant hypotensive (vasovagal/hypovolemia) adverse events according to the plasma center adverse event reporting system, based on the IQPP definitions of Signs/Symptoms/Findings, in the subgroups of donors with a body mass index (BMI) of less than or equal to 30 and of those greater than 30.
Measured: Up to approximately 3 months, depending on time of enrollment into the trial.
Rate of Significant Hypotensive Adverse Events Relative to Donor Status
Incidence rate of significant hypotensive (vasovagal/hypovolemia) adverse events according to the plasma center adverse event reporting system, based on the IQPP definitions of Signs/Symptoms/Findings, in the subgroups of donors defined by their respective status as a first-time donor or repeat donor.
Measured: Up to approximately 3 months, depending on time of enrollment into the trial.
Rate of Significant Hypotensive Adverse Events Relative to Gender
Incidence rate of significant hypotensive (vasovagal/hypovolemia) adverse events according to the plasma center adverse event reporting system, based on the IQPP definitions of Signs/Symptoms/Findings, in the subgroups of donors defined by their gender.
Measured: Up to approximately 3 months, depending on time of enrollment into the trial.
Total Volume
Total plasma volume collected per procedure.
Measured: Up to approximately 3 months, depending on time of enrollment into the trial.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Jan 202027 Apr 2020

First posted25 Mar 2020
Study start6 Jan 2020
Primary completion27 Mar 2020
Study completion27 Apr 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Apheresis Related HypotensionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Model description: Two-arm, randomized, controlled trial
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 3,443 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04320823
Sponsor's protocol ID: TP-CLN-100467
Acronym: IMPACT
Status last verified: Mar 2021
First submitted: 3 Jan 2020
Last updated: 9 Apr 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes

Publications

Hartmann J, Ragusa MJ, Burchardt ER, Manukyan Z, Popovsky MA, Leitman SF. Personalized collection of plasma from healthy donors: A randomized controlled trial of a novel technology-enabled nomogram. Transfusion. 2021 Jun;61(6):1789-1798. doi: 10.1111/trf.16389. Epub 2021 Apr 21.
PubMed 33760230

Study at a glance

From the registry record, last updated by the sponsor on 9 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective, Randomized, Controlled, Multicenter Clinical Trial to Demonstrate the Safety and Effectiveness of the NexSys® PCS Plasma Collection System With the Percent Plasma Nomogram (PPN) Feature
ClinicalTrials.gov ID: NCT04320823
Acronym / sponsor ID: IMPACT / TP-CLN-100467
Conditions: Apheresis Related Hypotension
Keywords: Plasmapheresis (Source plasma collection)
Study type: Interventional
Recruitment status: Completed
Enrolment: 3,443 participants (actual)
Lead sponsor: Haemonetics CorporationIndustry (pharma, biotech, devices)
Study start: 6 Jan 2020 (actual)
Primary completion: 27 Mar 2020 (actual)
Study completion: 27 Apr 2020 (actual)
First posted: 25 Mar 2020 (actual)
Results: Posted 9 Apr 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Prospective, multi-center, randomized, controlled clinical trial to study the safety and effectiveness of a novel plasma collection system software.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2
Model description: Two-arm, randomized, controlled trial

Arm	Type	Receives
Experimental Group	Experimental	Device: Updated Plasma Collection FeaturePlasma collection using a modified version (version 1.3.90) of NexSys PCS embedded software installed on current FDA-cleared NexSys PCS device hardware (PCS-300-US), with the new plasma collection feature enabled.
Control Group	Active comparator	Device: Current Plasma Collection ApproachPlasma collection using a modified version (version 1.3.90) of NexSys® PCS embedded software installed on current FDA-cleared NexSy PCS device hardware (PCS-300-US), with the new plasma collection feature disabled.

Who may qualify

Ages: 18 to 66 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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.

Key exclusion criteria (5 listed)

All subjects meeting any of the exclusion criteria listed below will be permanently excluded from the clinical trial.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Updated Plasma Collection FeaturePlasma collection using a novel, patented system that supports a more individualized collection approach.	Device	Experimental Group
Current Plasma Collection ApproachPlasma collection using the current collection approach.	Device	Control Group

Primary outcome

Rate of Significant Hypotensive Adverse Events
Time frame: Up to approximately 3 months (total trial duration during which donors could donate), depending on time of enrollment into the trial.
The incidence rate of at least one significant hypotensive (vasovagal/hypovolemia) adverse event according to the plasma center adverse event reporting system, based on IQPP definitions of Signs/Symptoms/Findings. Significant adverse events are defined as such events that fulfill the Signs/Symptoms/Findings of IQPP Donor Adverse Events (DAE) classifications 1.2 through 1.6 per the modified, symptoms-based approach following the plasma center adverse event reporting system. A Model Based Prediction method was used for this outcome.

8 secondary outcomes

Rate of Severe Hypotensive Adverse Events
Time frame: Up to approximately 3 months, depending on time of enrollment into the trial.
Rate of Significant Hypotensive Adverse Events Relative to Volume
Time frame: Up to approximately 3 months, depending on time of enrollment into the trial.
Time From Start of Collection to First Significant Hypotensive Adverse Event
Time frame: Up to approximately 3 months, depending on time of enrollment into the trial.
Rate of Significant Hypotensive Adverse Events Relative to Bodyweight
Time frame: Up to approximately 3 months, depending on time of enrollment into the trial.
Rate of Significant Hypotensive Adverse Events Relative to BMI
Time frame: Up to approximately 3 months, depending on time of enrollment into the trial.
Rate of Significant Hypotensive Adverse Events Relative to Donor Status
Time frame: Up to approximately 3 months, depending on time of enrollment into the trial.
Rate of Significant Hypotensive Adverse Events Relative to Gender
Time frame: Up to approximately 3 months, depending on time of enrollment into the trial.
Total Volume
Time frame: Up to approximately 3 months, depending on time of enrollment into the trial.

Results and safety

Results posted to the registry on 9 Apr 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Experimental Group	1,717	1,717
Control Group	1,726	1,726

Primary outcome: Rate of Significant Hypotensive Adverse Events

Time frame: Up to approximately 3 months (total trial duration during which donors could donate), depending on time of enrollment into the trial.. Number (95% Confidence Interval). Unit: % of significant hypotensive AEs

Measure	Experimental Group n = 1717	Control Group n = 1726
Value	.035 (.010 to .094)	.051 (.020 to .114)

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events were monitored and collected for all donations of study participants throughout the entire duration of the clinical trial, approximately 3 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Experimental Group	0 of 1,717 (0%)	76 of 1,717 (4.4%)	0 of 1,717
Control Group	0 of 1,726 (0%)	66 of 1,726 (3.8%)	0 of 1,726

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33760230Hartmann J, Ragusa MJ, Burchardt ER, Manukyan Z, Popovsky MA, Leitman SF. Personalized collection of plasma from healthy donors: A randomized controlled trial of a novel technology-enabled nomogram. Transfusion. 2021 Jun;61(6):1789-1798. doi: 10.1111/trf.16389. Epub 2021 Apr 21.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Susan F Leitman, MD principal investigator

National Institutes of Health (NIH)

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Updated Plasma Collection Feature and Current Plasma Collection Approach in people with Apheresis Related Hypotension, run by Haemonetics Corporation at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of Significant Hypotensive Adverse Events (time frame: Up to approximately 3 months (total trial duration during which donors could donate), depending on time of enrollment into the trial.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04320823, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2021.