- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03097289
In Vivo Recovery and Survival Study of Platelets Collected on Trima Accel System and Stored in InterSol Solution
An In Vivo Recovery and Survival Study of Platelets Collected on the Trima Accel System and Stored in InterSol Solution
Study Overview
Detailed Description
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.
Terumo BCT is pursuing FDA clearance for InterSol in combination with the Trima Accel system in order to provide blood centers with the option to use InterSol as well as Isoplate Solution when collecting platelets to be stored in a PAS.
This is a prospective, open-label, multicenter, controlled study. Up to 40 healthy adult subjects will be enrolled in this study to ensure 24 evaluable subjects across two Investigational Sites. Evaluable is defined as the subject completing the recovery and survival procedure and neither the subject or the product meeting any of the Clinical Investigation Plan (CIP) analysis exclusion criteria.
The additional platelet donors account for screen failures, incomplete procedures and CIP exclusions.
Two (2) sets of platelets will be collected from each subject:
- A Test unit - A hyperconcentrated platelet product collected on the Trima Accel system and diluted to a final ratio of 65% InterSol/35% plasma through the addition of InterSol directly to the platelet bag by the Trima Accel system after collection.
- A Control sample - Fresh platelets prepared from a whole blood sample drawn from the same subject on Study Day 5 in accordance with standard procedure.
Eligible donors who have signed an informed consent will be enrolled.
SUBJECT PROCEDURES
Screening can be performed within 5 days of the apheresis procedure or combined with the 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, race, ethnic origin), height, and weight
- Record medical history as per AABB criteria for healthy donors
Apheresis Visit
The following procedures will be performed:
- Eligibility will be confirmed
- Finger stick hemoglobin
- Apheresis procedure
Apheresis procedures will be run according to the instructions and precautions described in the commercially available Trima Accel Operator's Manual.
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 information will be documented:
- Trima procedure details
- Adverse events (AEs)
- Medications to treat adverse events
- Device deficiencies
Infusion Day Visit
Five (5) days after a study subject has completed the apheresis procedure to collect Test platelets, they will return for the donation of fresh Control platelets, reinfusion of radiolabeled Test and Control platelets, and post-infusion sampling.
The following procedures will be conducted:
- Confirm eligibility
- Conduct pregnancy test for women of childbearing potential (serum or urine)
- Review adverse events since the previous visit
- Collect a whole blood sample for the production of Control platelets
- Radiolabel Test and Control platelets and prepare for infusion
- Infuse radiolabeled combined Test and Control platelets into subject's vein
- Collect a 5-10 mL blood sample for pre- and post-infusion testing using the opposite arm as for the infusion
The following will be documented:
- Vital signs (blood pressure, heart rate, temperature)
- Adverse events
- Medications to treat adverse events
The subject will return to the study site daily (except on weekends) between Study Day 6 and Study Day 12 . A total of 5 blood samples are required to be collected in this 7 day period in order for the subject's data to be evaluable. The subject will also return to the study site for a final visit on Study Day 16.
At each of these visits a blood sample will be collected for testing.
The following will be documented:
- Adverse events
- Medications to treat adverse events
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ohio
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Cincinnati, Ohio, United States, 45267
- Hoxworth Blood Center
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Wisconsin
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Milwaukee, Wisconsin, United States, 53233
- BloodCenter of Wisconsin
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 18 years or older
- Normal health status as per AABB criteria for a healthy donor
- Able to commit to the study schedule
- Meets the inclusion criteria defined by the Blood Center for an apheresis platelet with PAS collection on the Trima Accel system. These criteria are based on FDA Regulations and AABB standards. Note: Participants who are deferred from volunteer community donations because of travel restrictions, piercings, or tattoos may participate in the study, as products are not transfused
- Participants of child-bearing potential (either male or female) must agree to use an effective method of contraception during the course of the study
- Female of childbearing potential must be willing to take a pregnancy test prior to infusion of radiolabeled platelets
- Has given written informed consent
Exclusion Criteria:
- Previously received radiation therapy
- Has been diagnosed with a platelet disorder (ie, platelet dysfunction)
- Already participated in 4 research studies involving radioisotopes within the contemporaneous calendar-year
- Pregnant or nursing females
- Participation currently, or within the last 12 months, in another investigational trial that would potentially interfere with the analysis of this investigation
- History of known hypersensitivity to indium or chromium
- Treatment with aspirin or aspirin containing medications within 7 days of apheresis or treatment with non-steroidal anti inflammatory drugs (NSAID), anti-platelet agents or other drugs affecting platelet viability within 3 days of apheresis (eg, ibuprofen or other NSAIDs)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Platelets stored in InterSol
Platelets collected on the Trima Accel system and stored in 65% InterSol/35% plasma
|
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 5 day storage.
The entire procedure is painless and should take 90 to 120 minutes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recovered Percentage of the Extrapolated Platelet Count at Time 0
Time Frame: 11 days (+/- 1 day)
|
The percent recovery of platelets stored in InterSol for 5 Days as compared to fresh controls.
Percent recovery was expressed as a percentage and was extrapolated for a value at Time 0. The FDA acceptance criteria for recovery is >66% of control with a 1-sided 97.5% confidence limit.
|
11 days (+/- 1 day)
|
Number of Days of Platelet Survival
Time Frame: 11 days (+/- 1 day)
|
Survival of platelets stored in InterSol for 5 Days as compared to fresh controls.
Survival was expressed in days and was approximated using linear regression.
The FDA acceptance criteria for survival is >58% of control with a 1-sided 97.5% confidence limit
|
11 days (+/- 1 day)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mehraboon S Irani, MD, Versiti
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CTS-5066
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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