Apheresis Related Hypotension
Conditions
Keywords
Plasmapheresis (Source plasma collection)
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.
Interventions
DEVICEUpdated Plasma Collection Feature
Plasma collection using a novel, patented system that supports a more individualized collection approach.
DEVICECurrent Plasma Collection Approach
Plasma collection using the current collection approach.
Sponsors
Haemonetics Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Two-arm, randomized, controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 66 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Significant Hypotensive Adverse Events | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Severe Hypotensive Adverse Events | Up to approximately 3 months, depending on time of enrollment into the trial. | 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 | Up to approximately 3 months, depending on time of enrollment into the trial. | 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 | Up to approximately 3 months, depending on time of enrollment into the trial. | 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. |
| Total Volume | Up to approximately 3 months, depending on time of enrollment into the trial. | Total plasma volume collected per procedure. |
| Rate of Significant Hypotensive Adverse Events Relative to BMI | Up to approximately 3 months, depending on time of enrollment into the trial. | 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 | Up to approximately 3 months, depending on time of enrollment into the trial. | 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 | Up to approximately 3 months, depending on time of enrollment into the trial. | 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. |
| Rate of Significant Hypotensive Adverse Events Relative to Bodyweight | Up to approximately 3 months, depending on time of enrollment into the trial. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Experimental Group 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.
Updated Plasma Collection Feature: Plasma collection using a novel, patented system that supports a more individualized collection approach. | 1,717 |
| Experimental Group 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.
Updated Plasma Collection Feature: Plasma collection using a novel, patented system that supports a more individualized collection approach. | 11,362 |
| Control Group 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.
Current Plasma Collection Approach: Plasma collection using the current collection approach. | 1,726 |
| Control Group 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.
Current Plasma Collection Approach: Plasma collection using the current collection approach. | 11,775 |
| Total | 26,580 |
Baseline characteristics
| Characteristic | Experimental Group | Control Group | Total |
|---|---|---|---|
| Age, Continuous | 35.5 years STANDARD_DEVIATION 11.69 | 35.4 years STANDARD_DEVIATION 11.1 | 35.4 years STANDARD_DEVIATION 11.4 |
| BMI | 32.1 kg/m^2 STANDARD_DEVIATION 7.74 | 31.8 kg/m^2 STANDARD_DEVIATION 7.75 | 32.0 kg/m^2 STANDARD_DEVIATION 7.74 |
| Donor Status First-Time | 109 Participants | 108 Participants | 217 Participants |
| Donor Status Repeat | 1608 Participants | 1618 Participants | 3226 Participants |
| Height | 67.5 in STANDARD_DEVIATION 3.6 | 67.5 in STANDARD_DEVIATION 3.62 | 67.5 in STANDARD_DEVIATION 3.61 |
| Hematocrit | 45.5 percentage of red blood cells STANDARD_DEVIATION 3.81 | 45.4 percentage of red blood cells STANDARD_DEVIATION 3.77 | 45.5 percentage of red blood cells STANDARD_DEVIATION 3.79 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 1717 participants | 1726 participants | 3443 participants |
| Sex: Female, Male Female | 605 Participants | 601 Participants | 1206 Participants |
| Sex: Female, Male Male | 1112 Participants | 1125 Participants | 2237 Participants |
| Weight | 207.5 lbs STANDARD_DEVIATION 50.99 | 206.1 lbs STANDARD_DEVIATION 51.33 | 206.8 lbs STANDARD_DEVIATION 51.16 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1,717 | 0 / 1,726 |
| other Total, other adverse events | 76 / 1,717 | 66 / 1,726 |
| serious Total, serious adverse events | 0 / 1,717 | 0 / 1,726 |
Outcome results
Primary
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.
Time frame: Up to approximately 3 months (total trial duration during which donors could donate), depending on time of enrollment into the trial.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental Group | Rate of Significant Hypotensive Adverse Events | .035 % of significant hypotensive AEs |
| Control Group | Rate of Significant Hypotensive Adverse Events | .051 % of significant hypotensive AEs |
Secondary
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.
Time frame: Up to approximately 3 months, depending on time of enrollment into the trial.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental Group | Rate of Severe Hypotensive Adverse Events | 1 Severe Hypotensive Adverse Events |
| Control Group | Rate of Severe Hypotensive Adverse Events | 1 Severe Hypotensive Adverse Events |
Secondary
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.
Time frame: Up to approximately 3 months, depending on time of enrollment into the trial.
Population: The total number of Participants Analyzed is more than the total population of donors in the study as some donors moved from one BMI group to the other throughout their participation in the study. Therefore, this analysis was done at the donation level, based on the BMI of each donor at the time of each donation. The number of donations are therefore also listed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental Group | Rate of Significant Hypotensive Adverse Events Relative to BMI | .043 % of significant hypotensive AEs |
| Control Group | Rate of Significant Hypotensive Adverse Events Relative to BMI | .020 % of significant hypotensive AEs |
| Experimental Group With Weight > 130 Lbs | Rate of Significant Hypotensive Adverse Events Relative to BMI | .03 % of significant hypotensive AEs |
| Control Group With Weight > 130 Lbs | Rate of Significant Hypotensive Adverse Events Relative to BMI | .074 % of significant hypotensive AEs |
Secondary
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.
Time frame: Up to approximately 3 months, depending on time of enrollment into the trial.
Population: The total number of Participants Analyzed is more than the total population of donors in the study as some donors moved from one bodyweight group to the other throughout their participation in the study. Therefore, this analysis was done at the donation level, based on the bodyweight of each donor at the time of each donation. The number of donations are therefore also listed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental Group | Rate of Significant Hypotensive Adverse Events Relative to Bodyweight | 0 % of significant hypotensive AEs |
| Control Group | Rate of Significant Hypotensive Adverse Events Relative to Bodyweight | 0 % of significant hypotensive AEs |
| Experimental Group With Weight > 130 Lbs | Rate of Significant Hypotensive Adverse Events Relative to Bodyweight | .036 % of significant hypotensive AEs |
| Control Group With Weight > 130 Lbs | Rate of Significant Hypotensive Adverse Events Relative to Bodyweight | .052 % of significant hypotensive AEs |
Secondary
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.
Time frame: Up to approximately 3 months, depending on time of enrollment into the trial.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental Group | Rate of Significant Hypotensive Adverse Events Relative to Donor Status | 0 % of significant hypotensive AEs |
| Control Group | Rate of Significant Hypotensive Adverse Events Relative to Donor Status | .247 % of significant hypotensive AEs |
| Experimental Group With Weight > 130 Lbs | Rate of Significant Hypotensive Adverse Events Relative to Donor Status | .037 % of significant hypotensive AEs |
| Control Group With Weight > 130 Lbs | Rate of Significant Hypotensive Adverse Events Relative to Donor Status | .044 % of significant hypotensive AEs |
Secondary
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.
Time frame: Up to approximately 3 months, depending on time of enrollment into the trial.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental Group | Rate of Significant Hypotensive Adverse Events Relative to Gender | .048 % of significant hypotensive AEs |
| Control Group | Rate of Significant Hypotensive Adverse Events Relative to Gender | .07 % of significant hypotensive AEs |
| Experimental Group With Weight > 130 Lbs | Rate of Significant Hypotensive Adverse Events Relative to Gender | .028 % of significant hypotensive AEs |
| Control Group With Weight > 130 Lbs | Rate of Significant Hypotensive Adverse Events Relative to Gender | .040 % of significant hypotensive AEs |
Secondary
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 frame: Up to approximately 3 months, depending on time of enrollment into the trial.
Population: This analysis was performed on the PP (per protocol) population, defined as all donations where the apheresis procedure was successfully completed collecting at least 90% of target plasma volume as well as all donations associated with a significant hypotensive (vasovagal/hypovolemia) adverse event according to the plasma center adverse event reporting system, based on the IQPP definitions of Signs/Symptoms/Findings.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental Group | Rate of Significant Hypotensive Adverse Events Relative to Volume | 4.27 No. of AEs per 10,000L of Plasma |
| Control Group | Rate of Significant Hypotensive Adverse Events Relative to Volume | 6.65 No. of AEs per 10,000L of Plasma |
Secondary
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.
Time frame: Up to approximately 3 months, depending on time of enrollment into the trial.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Group | Time From Start of Collection to First Significant Hypotensive Adverse Event | 30.41 minutes | Standard Deviation 16.52 |
| Control Group | Time From Start of Collection to First Significant Hypotensive Adverse Event | 51.59 minutes | Standard Deviation 17.09 |
Secondary
Total Volume
Total plasma volume collected per procedure.
Time frame: Up to approximately 3 months, depending on time of enrollment into the trial.
Population: This analysis was performed on the PP (per protocol) population, defined as all donations where the apheresis procedure was successfully completed collecting at least 90% of target plasma volume as well as all donations associated with a significant hypotensive (vasovagal/hypovolemia) adverse event according to the plasma center adverse event reporting system, based on the IQPP definitions of Signs/Symptoms/Findings.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Experimental Group | Total Volume | 841.69 mL |
| Control Group | Total Volume | 777.84 mL |