Prospective, multi-center, randomized, controlled clinical trial to study the safety and effectiveness of a novel plasma collection system software.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
3,443
Plasma collection using a novel, patented system that supports a more individualized collection approach.
Plasma collection using the current collection approach.
Octapharma Plasma
Wichita, Kansas, United States
Octapharma Plasma
Charlotte, North Carolina, United States
Octapharma Plasma
Spokane, Washington, United States
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.
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.
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.
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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.
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.
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.
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.
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.
Total Volume
Total plasma volume collected per procedure.
Time frame: Up to approximately 3 months, depending on time of enrollment into the trial.