Platelet TransfusionPhase 1CAPPNCT02754414
Cold Apheresis Platelets in PAS
A Phase 1 study testing Apheresis platelet collection, Refrigerated storage of apheresis platelets in PAS/plasma and Infusion of aliquot of autologous radiolabeled platelets in people with Platelet Transfusion, run by Bloodworks at 1 site in United States.
Trial summary
This is a platelet transfusion study. The purpose of this study is to measure the life span and quality of platelets stored in a refrigerator. Participants will give platelets by apheresis. Platelets will be stored for 3 -20 days. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Platelet Transfusion
- What is being tested?
- Apheresis platelet collection, Refrigerated storage of apheresis platelets in PAS/plasma and Infusion of aliquot of autologous radiolabeled platelets
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to Jan 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Weight: ≥ 110 pounds
- Platelet count: ≥ 150X10^3/mL
- Hematocrit: 38% for females, 39% for males, but not >55%
- Temperature: ≤ 99.5 F
- Resting blood pressure: systolic ≤180 mmHg; diastolic ≤ 100 mmHg
- Resting heart rate: 40 to 100 beats per minute
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- Subjects must be: at least 18 years old, of either sex
- Subjects must be able to read, understand and sign the informed consent document and commit to the study follow-up schedule. The ability to read and speak English is required for participation.
- Subjects must have good veins for apheresis platelet collection and drawing blood samples.
- Subjects of child-bearing potential (either male or female) must agree to use an effective method of contraception during the course of the study. The following methods of contraception are be considered effective; abstinence, intrauterine contraception devices, hormonal methods, barrier methods or history of sterilization.
Who cannot join
- Healthy subjects will be excluded from the study for any of the following reasons:
- Unable to achieve target platelet yield of 3.0 X 1011/unit per Trima Accel (apheresis machine) configuration parameters.
- Ever received radiation therapy.
- Already participated in 4 research studies involving radioisotopes within the contemporaneous calendar-year.
- Taken aspirin, non-steroidal anti-inflammatory, or other platelet affecting drugs within 72 hours of collection or infusion. Subjects who have ever been prescribed anti-platelet medications (e.g. clopidogrel) will be excluded from study participation regardless of the interval to their last dose.
- Currently pregnant or nursing as assessed during interview. A urine pregnancy test prior to radioisotope infusion is required for women of childbearing potential.
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- Unable to comply with the protocol in the opinion of the investigator.
- Donated granulocytes within the last 2 days.
- Donated whole blood within the last 7 days.
- Donated platelets or plasma within the last 28 days.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Bloodworks Northwest (formerly Puget Sound Blood Center)
Seattle, Washington, 98102
Lynda B Fitzpatrick, RN, 206-689-6285, lyndaf@BloodWorksNW.org
About this study
This is a platelet transfusion study. The purpose of this study is to measure the life span and quality of platelets stored in a refrigerator. Participants will give platelets by apheresis. Platelets will be stored for 3 -20 days. A small portion of the subject's own stored platelets will be tagged with a radioactive isotope and infused back into the participant. This will enable us to track how many transfused platelets survive after storage in the refrigerator.
Read the detailed description
A single hyperconcentrated apheresis platelet unit will be collected from a healthy adult volunteer subject using the Trima Accel® Automated Blood Collection System. Concurrent plasma will be collected. The platelet unit will be stored, not-agitated, for up to 20 days at 4°C in a suspension of 35% plasma and 65% PAS (Platelet Additive Solution).
At the end of the storage period, the subject will return to receive an 111Indium Oxine (Indium 111, In-111) radiolabeled aliquot of their 4°C stored platelets. Follow-up samples from the subject will be collected approximately 2 hours post-infusion and on Days 1 (2X), 2 (2X), and 3 to calculate recovery and survival of the subject's 4°C stored platelets. The Day 1 and Day 2 the sample draws will be 2 - 10 hours apart.
In addition to radiolabeled platelet recovery and survival measurements, various in vitro assays will be performed on the day of collection at the end of 4°C storage.
One week after the infusion of the radiolabeled aliquot, the subject will return to receive a second radiolabeled aliquot of fresh platelets. To facilitate this, on the morning of the second infusion, the subject will return for collection of a 43 mL blood sample. The blood will be processed to obtain a fresh sample of the subject's platelets to serve as a control comparator. The platelets will be radiolabeled with In-111. The subject will return later in the day for infusion of the radiolabeled fresh 'control' comparator aliquot. Follow-up blood samples will be drawn at ~2 hours after the infusion on Day 0 and then on Days 1, 2, 3, 4 or 5, and 6 or 7 day post infusion to calculate recovery and survival of the subject's fresh vs. stored platelets.
- Conditions
- Platelet Transfusion
- Being tested
- Apheresis platelet collection, Refrigerated storage of apheresis platelets in PAS/plasma, Infusion of aliquot of autologous radiolabeled platelets, In vitro tests
- Keywords
- platelets, transfusion, cold storage, apheresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apheresis platelet collectionProcedure or surgery
A single apheresis platelet unit will be collected from a healthy adult volunteer subject using the Trima Accel® Automated Blood Collection System. Concurrent plasma will be collected.
Refrigerated storage of apheresis platelets in PAS/plasmaOther
The apheresis platelet unit will be stored, without agitation, at 4°C, for up to 20 days.
Infusion of aliquot of autologous radiolabeled plateletsRadiation
Fresh and stored aliquots will be labeled with Indium-111. We are administering ≤30 microcuries in both infusions for a total dose of 0.8 mSv.
In vitro testsOther
Tests to evaluate platelet function will be performed on the platelet unit on day of collection and end of storage
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Experimental | Autologous, cold stored, PAS/plasma suspended platelets stored for various periods (3 to 20 days). Receives: Procedure: Apheresis platelet collection; Other: Refrigerated storage of apheresis platelets in PAS/plasma; Radiation: Infusion of aliquot of autologous radiolabeled platelets; Other: In vitro tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal storage time with acceptable recovery and survival (as defined below)
Tables of recovery and survival summary statistics will display values by group from fresh and stored platelets. Recovery and survival of stored platelets as percentage of corresponding fresh platelets will be plotted against days stored. Regression methods will be used to determine if there is evidence of any trend in the mean storage or recovery of 4°C stored platelets with respect to storage time as a percentage of each subject's fresh platelet results. Histograms of recovery and survival as percentage of 4°C stored platelet measurements will be plotted, and corresponding confidence intervals will be calculated.
Measured: up to 20 days storage at 4°C
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionDec 2018 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Platelet TransfusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bloodworks
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moritz Stolla, MD, Bloodworks
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02754414
- Sponsor's protocol ID
- 2016 - 01
- Other IDs
- CAPI
- Acronym
- CAPP
- Status last verified
- May 2018
- First submitted
- 7 Apr 2016
- Last updated
- 14 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cold Apheresis Platelets in PAS
- ClinicalTrials.gov ID
- NCT02754414
- Acronym / sponsor ID
- CAPP / 2016 - 01
- Conditions
- Platelet Transfusion
- Keywords
- platelets, transfusion, cold storage, apheresis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- BloodworksUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 28 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a platelet transfusion study. The purpose of this study is to measure the life span and quality of platelets stored in a refrigerator. Participants will give platelets by apheresis. Platelets will be stored for 3 -20 days. A small portion of the subject's own stored platelets will be tagged with a radioactive isotope and infused back into the participant. This will enable us to track how many transfused platelets survive after storage in the refrigerator.
Detailed description
A single hyperconcentrated apheresis platelet unit will be collected from a healthy adult volunteer subject using the Trima Accel® Automated Blood Collection System. Concurrent plasma will be collected. The platelet unit will be stored, not-agitated, for up to 20 days at 4°C in a suspension of 35% plasma and 65% PAS (Platelet Additive Solution).
At the end of the storage period, the subject will return to receive an 111Indium Oxine (Indium 111, In-111) radiolabeled aliquot of their 4°C stored platelets. Follow-up samples from the subject will be collected approximately 2 hours post-infusion and on Days 1 (2X), 2 (2X), and 3 to calculate recovery and survival of the subject's 4°C stored platelets. The Day 1 and Day 2 the sample draws will be 2 - 10 hours apart.
In addition to radiolabeled platelet recovery and survival measurements, various in vitro assays will be performed on the day of collection at the end of 4°C storage.
One week after the infusion of the radiolabeled aliquot, the subject will return to receive a second radiolabeled aliquot of fresh platelets. To facilitate this, on the morning of the second infusion, the subject will return for collection of a 43 mL blood sample. The blood will be processed to obtain a fresh sample of the subject's platelets to serve as a control comparator. The platelets will be radiolabeled with In-111. The subject will return later in the day for infusion of the radiolabeled fresh 'control' comparator aliquot. Follow-up blood samples will be drawn at ~2 hours after the infusion on Day 0 and then on Days 1, 2, 3, 4 or 5, and 6 or 7 day post infusion to calculate recovery and survival of the subject's fresh vs. stored platelets.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | Experimental | Procedure: Apheresis platelet collection, Other: Refrigerated storage of apheresis platelets in PAS/plasma, Radiation: Infusion of aliquot of autologous radiolabeled platelets, Other: In vitro testsAutologous, cold stored, PAS/plasma suspended platelets stored for various periods (3 to 20 days). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Weight: ≥ 110 pounds
- Platelet count: ≥ 150X10^3/mL
- Hematocrit: 38% for females, 39% for males, but not >55%
- Temperature: ≤ 99.5 F
- Resting blood pressure: systolic ≤180 mmHg; diastolic ≤ 100 mmHg
Key exclusion criteria (10 listed)
- Unable to achieve target platelet yield of 3.0 X 1011/unit per Trima Accel (apheresis machine) configuration parameters.
- Ever received radiation therapy.
- Already participated in 4 research studies involving radioisotopes within the contemporaneous calendar-year.
- Taken aspirin, non-steroidal anti-inflammatory, or other platelet affecting drugs within 72 hours of collection or infusion. Subjects who have ever been prescribed anti-platelet medications (e.g. clopidogrel) will be excluded from study participation regardless of the interval to their last dose.
- Currently pregnant or nursing as assessed during interview. A urine pregnancy test prior to radioisotope infusion is required for women of childbearing potential.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Apheresis platelet collectionA single apheresis platelet unit will be collected from a healthy adult volunteer subject using the Trima Accel® Automated Blood Collection System. Concurrent plasma will be collected. | Procedure or surgery | Healthy Volunteers |
| Refrigerated storage of apheresis platelets in PAS/plasmaThe apheresis platelet unit will be stored, without agitation, at 4°C, for up to 20 days. | Other | Healthy Volunteers |
| Infusion of aliquot of autologous radiolabeled plateletsFresh and stored aliquots will be labeled with Indium-111. We are administering ≤30 microcuries in both infusions for a total dose of 0.8 mSv. | Radiation | Healthy Volunteers |
| In vitro testsTests to evaluate platelet function will be performed on the platelet unit on day of collection and end of storage | Other | Healthy Volunteers |
Primary outcome
Maximal storage time with acceptable recovery and survival (as defined below)
Time frame: up to 20 days storage at 4°C
Tables of recovery and survival summary statistics will display values by group from fresh and stored platelets. Recovery and survival of stored platelets as percentage of corresponding fresh platelets will be plotted against days stored. Regression methods will be used to determine if there is evidence of any trend in the mean storage or recovery of 4°C stored platelets with respect to storage time as a percentage of each subject's fresh platelet results. Histograms of recovery and survival as percentage of 4°C stored platelet measurements will be plotted, and corresponding confidence intervals will be calculated.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Apheresis platelet collection, Refrigerated storage of apheresis platelets in PAS/plasma and Infusion of aliquot of autologous radiolabeled platelets in people with Platelet Transfusion, run by Bloodworks at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lynda Fitzpatrick, RN (206-689-6285, lyndaf@BloodWorksNW.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal storage time with acceptable recovery and survival (as defined below) (time frame: up to 20 days storage at 4°C). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2018.