Reversal of Platelet Aggregation InhibitorsPhase 1/2RASPNCT05111028
Reversal of Aspirin Antiplatelet Therapy With Cold Stored Platelets
A Phase 1/2 study testing Autologous Room Temperature stored Platelet transfusion and Autologous Cold Stored Platelet transfusion in people with Reversal of Platelet Aggregation Inhibitors, run by Bloodworks at 1 site in United States.
Trial summary
Purpose of this study is to compare the reversal responses of 4°C cold stored platelets (CSP) versus 7 day, 22°C room temperature stored platelets (RTP) when given to healthy adult subjects who have received a loading dose of aspirin antiplatelet therapy. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Reversal of Platelet Aggregation Inhibitors
- What is being tested?
- Autologous Room Temperature stored Platelet transfusion and Autologous Cold Stored Platelet transfusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2020to Nov 2021
- Phase
- Phase 1/2
- 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 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject feels healthy and well
- 18-59 years old
- All sexes
- Temperature <99.6 F
- Resting blood pressure: systolic <181 mmHg, diastolic <101 mmHg
- Resting heart rate: 40 - 100 beats per minute
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- Weight: >109 lb
- Hematocrit: >34% for female subjects, >37% for male subjects. <56% for all subjects.
- Platelet count able to achieve target platelet yield per apheresis machine configuration parameters
- 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
- Subject must agree to avoid taking any aspirin or aspirin-containing drugs (e.g., Alka-Seltzer®, Bufferin®, Excedrin®) or NSAIDs (e.g.,Feldene®, Motrin®, Aleve®, Advil®) or other drugs known to significantly affect platelet function throughout their study participation determined by PI
- Subjects must have "good veins" for apheresis platelet collection and drawing blood samples
- Women of child-bearing potential must agree to use an effective method of contraception during the course of the study. The following methods of contraception will be considered 'effective' when self-reported by subject; abstinence, intrauterine contraception devices, hormonal methods, barrier methods or history of sterilization
- Subject has phone and e-mail for contact and notification, and is able to come to the research site for study visits
Who cannot join
- Active acute infection or suspected active infection or taking antibiotics.
- Active immune/inflammatory condition (e.g. gout, systemic lupus erythematosus, allograft rejection).
- History of heart disease, including endorsement of shortness of breath with mild exertion (at the discretion of the PI).
- History of significant liver, kidney, GI, blood, endocrine/metabolic, autoimmune or pulmonary disease, untreated hypertension and or metabolic syndrome (at the discretion of the PI).
- Diabetes Mellitus.
- Cancer of any kind (exceptions being basal or squamous cell cancers of the skin), under treatment or resolved.
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- History of bleeding events, family history of bleeding events, or known genetic disorder with bleeding diathesis.
- A family history of venous or arterial thrombosis before the age of 50 in first degree relatives.
- A personal history of DVT, venous or arterial thrombosis, blood clots or stroke.
- History of or currently prescribed antiplatelet therapies [such as clopidogrel (Plavix), ticlopidine (Ticlid) or Ticagrelor (Brilinta)] and/or anticoagulant therapies [such as heparin, enoxaparin (Lovenox), warfarin (Coumadin), apixaban (Eliquis), dabigatran (Pradaxa), edoxaban (Savaysa), rivaroxaban (Xarelto)].
- Subject has taken any aspirin or aspirin-containing drugs (e.g., Alka-Seltzer®, Bufferin®, Excedrin®) or NSAIDs (e.g.,Feldene®, Motrin®, Aleve®, Advil®) or other drugs known to significantly affect platelet function within 14 days prior to screening as determined by PI.
- Chronic NSAID therapy.
- Chronic steroid therapy.
- Known allergy to aspirin.
- Current drug or alcohol dependence by subject's declaration.
- Currently pregnant or nursing as assessed during interview. A urine pregnancy test prior to apheresis is required for women of childbearing potential.
- Subject plans to participate in contact sports during study/observational period such as boxing, rugby, American football, soccer, or other risky recreational hobbies at the discretion of the investigator.
- Unwilling or unable to comply with the protocol in the opinion of the investigator.
- Participation in an experimental drug/device study within the past 30 days (other than this study). Subjects who have received an infusion on this study may not be re-enrolled.
- Other unspecified reasons that, in the opinion of the Investigator, make the subject unsuitable for enrollment
Trial locations and contacts
1 site in 1 country.
United States1 site
Bloodworks Northwest Research Institute
Seattle, Washington, 98102
About this study
Purpose of this study is to compare the reversal responses of 4°C cold stored platelets (CSP) versus 7 day, 22°C room temperature stored platelets (RTP) when given to healthy adult subjects who have received a loading dose of aspirin antiplatelet therapy.
- Being tested
- Autologous Room Temperature stored Platelet transfusion, Autologous Cold Stored Platelet transfusion
- Keywords
- Aspirin, Blood Platelets, Platelet Aggregation Inhibitors, Platelet Transfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Room Temperature stored Platelet transfusionBiological
An autologous transfusion of platelets stored at 22°C for 7 days.
Autologous Cold Stored Platelet transfusionBiological
An autologous transfusion of platelets stored at 4°C for 7, 14, 21, or 28 days.
| Study group | Role | What they receive |
|---|---|---|
| Period 1 | Active comparator | Each research subject will participate in two study periods that will crossover from one storage product to the other storage product (Cold Stored Platelets vs Room Temperature Platelets) based on the randomization assignment. In Period 1 subjects will undergo an apheresis platelet collection, aspirin dosing, transfusion of their autologous platelets, and followed by platelet response testing and safety assessments. This is repeated in Period 2 using the other storage product. CSP is the the experimental comparator and RTP is the active comparator. Receives: Biological: Autologous Room Temperature stored Platelet transfusion; Biological: Autologous Cold Stored Platelet transfusion |
| Period 2 | Experimental | Each research subject will participate in two study periods that will crossover from one storage product to the other storage product (Cold Stored Platelets vs Room Temperature Platelets) based on the randomization assignment. In Period 1 subjects will undergo an apheresis platelet collection, aspirin dosing, transfusion of their autologous platelets, and followed by platelet response testing and safety assessments. This is repeated in Period 2 using the other storage product. CSP is the the experimental comparator and RTP is the active comparator. Receives: Biological: Autologous Room Temperature stored Platelet transfusion; Biological: Autologous Cold Stored Platelet transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycoprotein IIb/IIIa activation at 1hr post transfusion
The primary endpoint is αIIbβ3 (GPIIb-IIIa) integrin activation determined by ARU (Verify Now Aspirin [ARUTest]) at 1h post autologous transfusion
Measured: 1 hour after autologous transfusion
Secondary outcomes (2)
Glycoprotein IIb/IIIa activation at 4hr post transfusion
A secondary endpoint is αIIbβ3 (GPIIb-IIIa) integrin activation determined by ARU (Verify Now Aspirin [ARUTest]) at 4h post autologous transfusion
Measured: 4 hours after autologous transfusion
Glycoprotein IIb/IIIa activation at 24hr post transfusion
A secondary endpoint is αIIbβ3 (GPIIb-IIIa) integrin activation determined by ARU (Verify Now Aspirin [ARUTest]) at 24h post autologous transfusion
Measured: 24 hours after autologous transfusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start20 Nov 2020
- Primary completionNov 2021 (estimated)
- Study completionNov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reversal of Platelet Aggregation InhibitorsStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bloodworks
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Moritz Stolla, MD, PhD, Principal investigator, Bloodworks
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05111028
- Sponsor's protocol ID
- 2020-01
- Acronym
- RASP
- Status last verified
- Oct 2021
- First submitted
- 27 Oct 2021
- Last updated
- 8 Nov 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Your data or specimens collected as part of this research will not be used for future research studies or given to anyone else for future research studies, even if all information that personally identifies you is removed.
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reversal of Aspirin Antiplatelet Therapy With Cold Stored Platelets
- ClinicalTrials.gov ID
- NCT05111028
- Acronym / sponsor ID
- RASP / 2020-01
- Keywords
- Aspirin, Blood Platelets, Platelet Aggregation Inhibitors, Platelet Transfusion
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (actual)
- Lead sponsor
- BloodworksUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 20 Nov 2020 (actual)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 8 Nov 2021 (actual)
- 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.
Purpose of this study is to compare the reversal responses of 4°C cold stored platelets (CSP) versus 7 day, 22°C room temperature stored platelets (RTP) when given to healthy adult subjects who have received a loading dose of aspirin antiplatelet therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Period 1 | Active comparator | Biological: Autologous Room Temperature stored Platelet transfusion, Biological: Autologous Cold Stored Platelet transfusionEach research subject will participate in two study periods that will crossover from one storage product to the other storage product (Cold Stored Platelets vs Room Temperature Platelets) based on the randomization assignment. In Period 1 subjects will undergo an apheresis platelet collection, aspirin dosing, transfusion of their autologous platelets, and followed by platelet response testing and safety assessments. This is repeated in Period 2 using the other storage product. CSP is the the experimental comparator and RTP is the active comparator. |
| Period 2 | Experimental | Biological: Autologous Room Temperature stored Platelet transfusion, Biological: Autologous Cold Stored Platelet transfusionEach research subject will participate in two study periods that will crossover from one storage product to the other storage product (Cold Stored Platelets vs Room Temperature Platelets) based on the randomization assignment. In Period 1 subjects will undergo an apheresis platelet collection, aspirin dosing, transfusion of their autologous platelets, and followed by platelet response testing and safety assessments. This is repeated in Period 2 using the other storage product. CSP is the the experimental comparator and RTP is the active comparator. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Subject feels healthy and well
- 18-59 years old
- All sexes
- Temperature <99.6 F
- Resting blood pressure: systolic <181 mmHg, diastolic <101 mmHg
Key exclusion criteria (20 listed)
- Active acute infection or suspected active infection or taking antibiotics.
- Active immune/inflammatory condition (e.g. gout, systemic lupus erythematosus, allograft rejection).
- History of heart disease, including endorsement of shortness of breath with mild exertion (at the discretion of the PI).
- History of significant liver, kidney, GI, blood, endocrine/metabolic, autoimmune or pulmonary disease, untreated hypertension and or metabolic syndrome (at the discretion of the PI).
- Diabetes Mellitus.
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 |
|---|---|---|
| Autologous Room Temperature stored Platelet transfusionAn autologous transfusion of platelets stored at 22°C for 7 days. | Biological | Period 1, Period 2 |
| Autologous Cold Stored Platelet transfusionAn autologous transfusion of platelets stored at 4°C for 7, 14, 21, or 28 days. | Biological | Period 1, Period 2 |
Primary outcome
Glycoprotein IIb/IIIa activation at 1hr post transfusion
Time frame: 1 hour after autologous transfusion
The primary endpoint is αIIbβ3 (GPIIb-IIIa) integrin activation determined by ARU (Verify Now Aspirin [ARUTest]) at 1h post autologous transfusion
2 secondary outcomes
Glycoprotein IIb/IIIa activation at 4hr post transfusion
Time frame: 4 hours after autologous transfusion
Glycoprotein IIb/IIIa activation at 24hr post transfusion
Time frame: 24 hours after autologous transfusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2021.
- Individual participant dataSharing planned: No. Your data or specimens collected as part of this research will not be used for future research studies or given to anyone else for future research studies, even if all information that personally identifies you is removed.
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.
Moritz Stolla, MD, PhD principal investigator
Bloodworks
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Autologous Room Temperature stored Platelet transfusion and Autologous Cold Stored Platelet transfusion in people with Reversal of Platelet Aggregation Inhibitors, 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 14 inclusion and 20 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 8 Nov 2021. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycoprotein IIb/IIIa activation at 1hr post transfusion (time frame: 1 hour after autologous transfusion). 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 8 Nov 2021.