Platelet Dysfunction Due to DrugsPhase 2NCT03338660
Platelet Function With Various Storage Techniques
A Phase 2 study testing Infusion of Platelets in people with Platelet Dysfunction Due to Drugs, run by Northwell Health.
Trial summary
Platelet function will be tested in individuals on antiplatelet medications to determine the optimal storage methodology. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Platelet Dysfunction Due to Drugs
- What is being tested?
- Infusion of Platelets
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2018to 15 Jul 2020
- Phase
- Phase 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Normal subjects
Who cannot join
- Pre existing antiplatelet drugs
About this study
Official title: The Impact of Various Storage Techniques on Platelet Function
Platelet function will be tested in individuals on antiplatelet medications to determine the optimal storage methodology.
Read the detailed description
Subjects will undergo administration of antiplatelet drugs and then will receive platelets stored in a variety of methods. Platelet function will be measured serially.
- Conditions
- Platelet Dysfunction Due to Drugs
- Being tested
- Infusion of Platelets, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infusion of PlateletsBiological
Also called Novel Storage Methodology
Platelets will be stored using novel, FDA approved, technique. Subjects will receive infusion of platelets stored by novel technique, routine storage, and placebo (saline).
Infusion of PlateletsBiological
Also called Routine Storage Method
Platelets will be stored using the routine platelet storage method. Subjects will receive infusion of platelets stored by routine storage method.
PlaceboBiological
Also called Placebo (Saline)
Subjects will receive infusion placebo (saline).
| Study group | Role | What they receive |
|---|---|---|
| Control (Placebo) | Placebo comparator | Subjects will receive infusion of placebo (saline). Receives: Biological: Placebo |
| Platelet storage routine | Active comparator | Subjects will receive infusion of platelets stored by routine method. Receives: Biological: Infusion of Platelets |
| Platelet storage experimental | Experimental | Subjects will receive infusion of platelets stored by a novel methodology. Receives: Biological: Infusion of Platelets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in platelet function
Frozen platelets will result in improvement in platelet function after transfusion.
Measured: 1 hour post-transfusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2017
- Study start15 Jul 2018 (estimated)
- Primary completion15 Jul 2019 (estimated)
- Study completion15 Jul 2020 (estimated)
Why it stopped: Unable to begin study due to funding. PI has left organization.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Platelet Dysfunction Due to DrugsStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- crossover study of various storage infusions techniques with each subject receiving various fluids aliquots.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03338660
- Sponsor's protocol ID
- 16-XXXX-SIUHN
- Status last verified
- May 2019
- First submitted
- 1 Feb 2017
- Last updated
- 29 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Various Storage Techniques on Platelet Function
- ClinicalTrials.gov ID
- NCT03338660
- Acronym / sponsor ID
- 16-XXXX-SIUHN
- Conditions
- Platelet Dysfunction Due to Drugs
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to begin study due to funding. PI has left organization.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- 15 Jul 2018 (estimated)
- Primary completion
- 15 Jul 2019 (estimated)
- Study completion
- 15 Jul 2020 (estimated)
- First posted
- 9 Nov 2017 (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.
Platelet function will be tested in individuals on antiplatelet medications to determine the optimal storage methodology.
Detailed description
Subjects will undergo administration of antiplatelet drugs and then will receive platelets stored in a variety of methods. Platelet function will be measured serially.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- crossover study of various storage infusions techniques with each subject receiving various fluids aliquots.
| Arm | Type | Receives |
|---|---|---|
| Control (Placebo) | Placebo comparator | Biological: PlaceboSubjects will receive infusion of placebo (saline). |
| Platelet storage routine | Active comparator | Biological: Infusion of PlateletsSubjects will receive infusion of platelets stored by routine method. |
| Platelet storage experimental | Experimental | Biological: Infusion of PlateletsSubjects will receive infusion of platelets stored by a novel methodology. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Normal subjects
Key exclusion criteria (1 listed)
- Pre existing antiplatelet drugs
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 |
|---|---|---|
| Infusion of PlateletsAlso: Novel Storage MethodologyPlatelets will be stored using novel, FDA approved, technique. Subjects will receive infusion of platelets stored by novel technique, routine storage, and placebo (saline). | Biological | Platelet storage experimental |
| Infusion of PlateletsAlso: Routine Storage MethodPlatelets will be stored using the routine platelet storage method. Subjects will receive infusion of platelets stored by routine storage method. | Biological | Platelet storage routine |
| PlaceboAlso: Placebo (Saline)Subjects will receive infusion placebo (saline). | Biological | Control (Placebo) |
Primary outcome
Change in platelet function
Time frame: 1 hour post-transfusion
Frozen platelets will result in improvement in platelet function after transfusion.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Infusion of Platelets in people with Platelet Dysfunction Due to Drugs, run by Northwell Health.
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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 29 May 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change in platelet function (time frame: 1 hour post-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 29 May 2019.