NCT04320823: IMPACT

IMPACT (Improving Plasma Collection) Clinical Trial

Completed NA Results posted Last updated 9 April 2021

What this trial tests

NA trial testing Updated Plasma Collection Feature in Apheresis Related Hypotension in 3,443 participants. Completed in 27 April 2020.

Timeline

6 January 2020

Primary endpoint
27 March 2020

27 April 2020

Quick facts

Lead sponsor	Haemonetics Corporation
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	other
Enrollment	3,443
Start date	6 January 2020
Primary completion	27 March 2020
Estimated completion	27 April 2020
Sites	3 locations across United States

Drugs / interventions tested

• Updated Plasma Collection Feature
• Current Plasma Collection Approach

Conditions studied

• Apheresis Related Hypotension — all drugs for Apheresis Related Hypotension →

Sponsor

Haemonetics Corporation — full company profile →

Who can join

Adults 18 to 66, any sex, with Apheresis Related Hypotension. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Rate of Significant Hypotensive Adverse Events Primary · 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.

Group	Value	95% CI
Experimental Group	.035	.010 – .094
Control Group	.051	.020 – .114

Rate of Severe Hypotensive Adverse Events Secondary · 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 wa

Group	Value	95% CI
Experimental Group	1
Control Group	1

Rate of Significant Hypotensive Adverse Events Relative to Volume Secondary · 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.

Group	Value	95% CI
Experimental Group	4.27
Control Group	6.65

Time From Start of Collection to First Significant Hypotensive Adverse Event Secondary · 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.

Group	Value	95% CI
Experimental Group	30.41	± 16.52
Control Group	51.59	± 17.09

Rate of Significant Hypotensive Adverse Events Relative to Bodyweight Secondary · 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.

Group	Value	95% CI
Experimental Group With Weight ≤ 130 Lbs	0	0 – 0
Control Group With Weight ≤ 130 Lbs	0	0 – 0
Experimental Group With Weight > 130 Lbs	.036	.010 – .096
Control Group With Weight > 130 Lbs	.052	.020 – .117

Rate of Significant Hypotensive Adverse Events Relative to BMI Secondary · 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.

Group	Value	95% CI
Experimental Group With BMI ≤ 30	.043	.001 – .168
Control Group With BMI ≤ 30 Lbs	.020	-.009 – .126
Experimental Group With BMI > 30	.03	.001 – .116
Control Group With BMI > 30	.074	.026 – .178

Rate of Significant Hypotensive Adverse Events Relative to Donor Status Secondary · 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.

Group	Value	95% CI
Experimental Group - First-Time Donor	0	0 – 1.095
Control Group - First-Time Donor	.247	0 – 1.531
Experimental Group - Repeat Donor	.037	.011 – .098
Control Group - Repeat Donor	.044	.016 – .106

Rate of Significant Hypotensive Adverse Events Relative to Gender Secondary · 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.

Group	Value	95% CI
Experimental Group - Female Donor	.048	.014 – .130
Control Group - Female Donor	.07	.028 – .155
Experimental Group - Male Donor	.028	.010 – .066
Control Group - Male Donor	.040	.018 – .082

Total Volume Secondary · Up to approximately 3 months, depending on time of enrollment into the trial.

Total plasma volume collected per procedure.

Group	Value	95% CI
Experimental Group	841.69	636 – 1000
Control Group	777.84	625 – 801

Adverse events — posted to ClinicalTrials.gov

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.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Experimental Group

Serious: 0/1717 (0%)

Deaths: 0/1717

Control Group

Serious: 0/1726 (0%)

Deaths: 0/1726

Other adverse events (13 terms — click to expand)

Reaction	System	Experimental Group	Control Group
IQPP 1.1 Hypotensive: Prefaint, No LOC (Minor)	Vascular disorders	—	—
IQPP 3.3 Local Injury Related to Phlebotomy: Hematoma/Bruise (complicated)	Injury, poisoning and procedural complications	—	—
IQPP 7.1 Allergic: Local	Immune system disorders	—	—
IQPP 4.1 Citrate Reaction: Minor	Injury, poisoning and procedural complications	—	—
3.1 Local Injury Related to Phlebotomy: Nerve Irritation	Injury, poisoning and procedural complications	—	—
IQPP 1.2 Hypotensive: Prefaint, No LOC (Moderate):	Vascular disorders	—	—
IQPP 9.1 Other	Nervous system disorders	—	—
IQPP 8.1 Hyperventilation	Respiratory, thoracic and mediastinal disorders	—	—
IQPP 4.2 Citrate Reaction: Moderate	Injury, poisoning and procedural complications	—	—
IQPP 3.2 Local Injury Related to Phlebotomy: Hematoma/Bruise (uncomplicated)	Injury, poisoning and procedural complications	—	—
IQPP 1.5 Hypotensive (Vasovagal/Hypovolemia); Severe (With or Without LOC)	Vascular disorders	—	—
IQPP 1.4 Hypotensive (Vasovagal/Hypovolemia): LOC (prolonged)	Vascular disorders	—	—
IQPP 1.3 Hypotensive: LOC (brief)	Vascular disorders	—	—

Data from ClinicalTrials.gov NCT04320823 adverse events section.

Sponsor's own description

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

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Personalized collection of plasma from healthy donors: A randomized controlled trial of a novel technology-enabled nomogram.
   Hartmann J, Ragusa MJ, Burchardt ER, Manukyan Z, et al · · 2021 · cited 11× · PMID 33760230 · DOI 10.1111/trf.16389
2. Repeat donation and deferral rates in US source plasma donors: Exploratory analysis from the IMPACT trial.
   Hartmann J, Ragusa MJ, Burchardt ER, Manukyan Z, et al · · 2021 · cited 3× · PMID 34309028 · DOI 10.1111/trf.16610
3. The Design of Large-Scale Plasma Donation Trials.
   Li K, Cook RJ. · · 2025 · PMID 40662859 · DOI 10.1002/sim.70181