In Vitro Study of Platelets Collected on Trima Accel System and Stored in InterSol Solution

Study Overview
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Brief Summary
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This study sought to verify that the in vitro quality (functional assays) of platelets collected on the Trima Accel system, Version 6.4, diluted in InterSol Solution, and stored for 1, 5, and 7 days meet FDA requirements.

Detailed Description
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Platelets suspended in platelet additive solutions (PAS) have been collected and transfused in Europe for over 20 years. These PAS solutions outside of the United States (US) are not tied to an apheresis device; however in the US, PAS solutions have traditionally been linked to a corresponding apheresis device. Currently in the US, there are two solutions approved by the Food and Drug Administration (FDA) as a PAS for the replacement of 65% plasma in platelet components. Isoplate Solution is approved for use with the Trima Accel® Automated Blood Collection System (Trima Accel System) and InterSol Solution is approved for use with the Amicus Separator System. This study is designed to provide blood centers with the option to use either Isoplate or InterSol when collecting platelets for use with PAS. Terumo BCT is pursuing approval for InterSol Solution in combination with the Trima Accel System. This is a randomized, paired, prospective, open-label, multi-center study. Up to 120 healthy adult subjects will be enrolled in this study to ensure 60 paired evaluable data points across two Investigational Sites. Evaluable is defined as two completed platelet products with 100mL plasma that do not meet any of the protocol analysis exclusion criteria. The additional platelet donors account for screen failures, incomplete procedures, and protocol exclusions. Two units of platelets will be collected from each subject: one Test unit collected as a hyperconcentrated platelet product with 100 mL of concurrent plasma and one Control unit of platelets in plasma collected according to standard procedure. The Test unit will be suspended in 65% Intersol/35% plasma immediately after collection; the Control unit will be maintained in 100% plasma. Eligible donors who have signed an informed consent will be enrolled. Randomization will occur in a ratio of 1:1 to one of the following Treatment Arms: Arm A: Collection of one Test unit followed by collection of one Control unit Arm B: Collection of one Control unit followed by collection of one Test unit The standard apheresis platelet units collected in the Control arm will mirror the hyperconcentrated platelet units in the Test arm in terms of yield and final concentration. SUBJECT PROCEDURES Screening can be performed within 30 days of the apheresis procedure or combined with the first Apheresis Visit. The following evaluations will be performed: Informed consent will be obtained prior to initiating any study specific procedures Eligibility will be confirmed Demographics (age, gender, ethnic origin), height, and weight Complete blood count (CBC) for hemoglobin and platelet count on subjects new to the Investigative Site that do not have historical hemoglobin and/or platelet count measurements Apheresis Visit The following procedures will be performed at both the first and second Apheresis Visits: Eligibility will be confirmed Finger stick hemoglobin First apheresis procedure will be performed Subject will return to the Site in 6 to 8 days following the first apheresis collection for the second apheresis collection. This will conclude the subject's participation. Apheresis procedures will be run according to the instructions and precautions described in the commercially available Trima Accel Operator's Manual for use with Version 6.4. The Investigator or designee will perform the venipuncture, monitor the subject during the collection, assess and provide any interventions for adverse effects, remove the needle, dress the puncture site and monitor subject through recovery. The following will be documented: Trima Procedure details Adverse events Medications to treat AEs Device deficiencies

Official Title
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In Vitro Study of Platelets Collected on Trima Accel System and Stored in InterSol Solution

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Device: Platelets stored in InterSol
* Device: Platelets stored in Plasma


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years of age or older Meet the inclusion criteria defined by the Investigational Site for an apheresis double platelet with plasma collection on the Trima Accel System. These criteria are based on American Association of Blood Banks (AABB) standards. Note: Subjects who are deferred from volunteer community donations because of travel restrictions, piercings or tattoos may participate in the study. Exclusion Criteria: None.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Platelets Stored in Plasma<br>Platelets stored in Plasma | Device: Platelets stored in Plasma<br>* A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. During the collection, plasma collected from the donor will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other.<br>|
| Experimental: Test Platelets Stored in InterSol<br>Platelets stored in InterSol | Device: Platelets stored in InterSol<br>* A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. Following each blood collection, Platelet Additive Solution (PAS), InterSol, will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pH of Platelets at Day 5 | The primary endpoint for this study is pH of platelets stored in InterSol at Day 5. The FDA acceptance criteria for pH is 95% of products have pH >6.2 at 22 degrees C with 95% confidence interval. A sample size of 60 subjects was chosen for the study to meet the acceptance criteria with 0 failures out of 60 Test products. | Day 5 | 
| pH of Platelets at Day 7 | The primary endpoint for this study is pH of platelets stored in InterSol at Day 7. The FDA acceptance criteria for pH is 95% of products have pH >6.2 at 22 degrees C with 95% confidence interval. A sample size of 60 subjects was chosen for the study to meet the acceptance criteria with 0 failures out of 60 Test products. | Day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Platelets Activated as Measured by P-selectin | Flow cytometric detection of platelet P-selectin expression (Units: %). Lower value is considered to indicate better platelet quality. | Day 5 | 
| Percent of Extent of Shape Change | Measures the proportion of platelets that have a discoid morphology (Units: %). Higher value is considered to indicate better platelet quality. | Day 5 | 
| Percent of Platelets Exhibiting Hypotonic Shock Response | Measures the ability of platelets to recover their volume after being exposed to a hypotonic environment (Units: % Recovery). Higher value is considered to indicate better platelet quality. | Day 5 | 
| Platelet Morphology | Quantifies (via phase-contrast light microscopy) the morphological changes of platelets coincident with the full range of platelet activation profile (Units: Kunicki score; Range is 0 to 400). Higher values represent healthier platelets. | Day 5 | 
| Percent of Platelets Activated as Measured by P-selectin | Flow cytometric detection of platelet P-selectin expression (Units: %). Lower value is considered to indicate better platelet quality. | Day 7 | 
| Percent of Extent of Shape Change | Measures the proportion of platelets that have a discoid morphology (Units: %). Higher value is considered to indicate better platelet quality. Higher value is considered to indicate better platelet quality. | Day 7 | 
| Percent of Platelets Exhibiting Hypotonic Shock Response | Measures the ability of platelets to recover their volume after being exposed to a hypotonic environment (Units: % Recovery). Higher value is considered to indicate better platelet quality. | Day 7 | 
| Platelet Morphology | Quantifies (via phase-contrast light microscopy) the morphological changes of platelets coincident with the full range of platelet activation profile (Units: Kunicki score; Range is 0 to 400). Higher values represent healthier platelets. | Day 7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy Adults