In-Vitro Study of Platelets Collected on Trima Accel System and Stored in InterSol Solution
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/18/2016 |
| Start Date: | November 2015 |
| End Date: | May 2016 |
Verify that in vitro platelet quality (functional assays) of platelets collected on the
Trima Accel System, Version 6.4, diluted in InterSol Solution, and stored for five days meet
FDA requirements.
Trima Accel System, Version 6.4, diluted in InterSol Solution, and stored for five days meet
FDA requirements.
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 100 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:
1. Informed consent will be obtained prior to initiating any study specific procedures
2. Eligibility will be confirmed
3. Demographics (age, gender, ethnic origin), height, and weight
4. 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:
1. Eligibility will be confirmed
2. Finger stick hemoglobin
3. 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:
1. Trima Procedure details
2. Adverse events
3. Medications to treat AEs
4. Device deficiencies
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 100 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:
1. Informed consent will be obtained prior to initiating any study specific procedures
2. Eligibility will be confirmed
3. Demographics (age, gender, ethnic origin), height, and weight
4. 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:
1. Eligibility will be confirmed
2. Finger stick hemoglobin
3. 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:
1. Trima Procedure details
2. Adverse events
3. Medications to treat AEs
4. Device deficiencies
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:
We found this trial at
2
sites
Cincinnati, Ohio 45267
Principal Investigator: Jose Cancelas, MD, PhD
Phone: 513-558-1525
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Milwaukee, Wisconsin 53233
Principal Investigator: Barbara Bryant, MD
Phone: 414-937-6295
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