IMPACT (Improving Plasma Collection) Clinical Trial - Clinical Trial for Apheresis Related Hypotension | NCT04320823

Back to results

Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Updated Plasma Collection Feature

Current Plasma Collection Approach

About this trial

This is an interventional other trial for Apheresis Related Hypotension focused on measuring Plasmapheresis (Source plasma collection)

Eligibility Criteria

18 Years - 66 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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- Subjects are withdrawn from the clinical trial due to safety concerns by the qualified healthcare providers.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

Sites / Locations

Octapharma Plasma
Octapharma Plasma
Octapharma Plasma

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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.

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.

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.

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.

Total Volume

Total plasma volume collected per procedure.

Full Information

NCT ID

NCT04320823

First Posted

January 3, 2020

Last Updated

March 16, 2021

Sponsor

Haemonetics Corporation

1. Study Identification

Unique Protocol Identification Number

NCT04320823

Brief Title

IMPACT (Improving Plasma Collection) Clinical Trial

Acronym

IMPACT

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Completed

Study Start Date

January 6, 2020 (Actual)

Primary Completion Date

March 27, 2020 (Actual)

Study Completion Date

April 27, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Haemonetics Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Apheresis Related Hypotension

Keywords

Plasmapheresis (Source plasma collection)

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Two-arm, randomized, controlled trial

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

3443 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Experimental Group

Arm Type

Experimental

Arm Description

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.

Arm Title

Control Group

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

Updated Plasma Collection Feature

Intervention Description

Plasma collection using a novel, patented system that supports a more individualized collection approach.

Intervention Type

Device

Intervention Name(s)

Current Plasma Collection Approach

Intervention Description

Plasma collection using the current collection approach.

Primary Outcome Measure Information:

Title

Rate of Significant Hypotensive Adverse Events

Description

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.

Time Frame

Up to approximately 3 months (total trial duration during which donors could donate), depending on time of enrollment into the trial.

Secondary Outcome Measure Information:

Title

Rate of Severe Hypotensive Adverse Events

Description

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.

Time Frame