Platelet-rich Plasma ProductionNCT03161743
Calculation of Platelet-rich Plasma Preparation Yield
An observational study of Platelet-rich Plasma Production, run by Harrison, Theodore, M.D. at 1 site in Canada.
Trial summary
This is a study to determine 1) the consistency of platelet-rich plasma produced by several methods, and 2) whether the platelet content of platelet-rich plasma can be accurately estimated from a baseline CBC platelet count. Read more about this study
- Who is it for?
- Ages 21 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Platelet-rich Plasma Production
- What is being tested?
- venipuncture
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 30 Jun 2017to 31 May 2018
- Phase
- Observational
- 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 21 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: normal adults
Who may be able to join
- English speaking
Who cannot join
- platelet count < 150,000
- platelet count > 350,000
- History of blood disorder
- History of altered platelet function
- History of chemotherapy or radiation therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Calculation of Platelet-rich Plasma Preparation Yield From Baseline CBC Platelet Count
This is a study to determine 1) the consistency of platelet-rich plasma produced by several methods, and 2) whether the platelet content of platelet-rich plasma can be accurately estimated from a baseline CBC platelet count.
Read the detailed description
In the first phase of this study a baseline CBC platelet count will be performed on each subject and then platelet-rich plasma (PRP) prepared from the same blood sample by six different methods. The platelet count will be measured in each PRP preparation and compared to the CBC platelet count to determine the platelet yield for each method.
In the second phase of the study a baseline CBC platelet count will be performed on each subject and then platelet-rich plasma (PRP) prepared from the same blood sample by six different methods. The CBC platelet count will be used to calculate the estimated platelet content of each sample/method based on the platelet yields determined in the first phase. The platelet count will be measured in each PRP preparation and compared to the estimated platelet content to determine the predictive accuracy for each method.
- Conditions
- Platelet-rich Plasma Production
- Being tested
- venipuncture
- Keywords
- platelet-rich plasma, platelet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
venipunctureProcedure or surgery
blood draw for the purpose of determining the platelet concentration in PRP
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet yield
the number of platelets in a PRP sample as a percentage of the number of platelets in the blood from which the PRP was prepared.
Measured: within 8 hours of blood draw
Platelet yield estimate accuracy
standard deviation of the difference between the estimated platelet yield and the actual platelet yield.
Measured: within one month of final data collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2017
- Study start30 Jun 2017
- Primary completion31 May 2018 (estimated)
- Study completion31 May 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Platelet-rich Plasma ProductionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harrison, Theodore, M.D.
- Responsible party
- Principal investigator, Theodore Harrison, MD, Harrison, Theodore, M.D.
- Investigators
- Theodore E Harrison, Principal investigator, Theodore Harrison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03161743
- Sponsor's protocol ID
- PRP Platelet Yield
- Status last verified
- Aug 2017
- First submitted
- 18 May 2017
- Last updated
- 10 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calculation of Platelet-rich Plasma Preparation Yield From Baseline CBC Platelet Count
- ClinicalTrials.gov ID
- NCT03161743
- Acronym / sponsor ID
- PRP Platelet Yield
- Conditions
- Platelet-rich Plasma Production
- Keywords
- platelet-rich plasma, platelet
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Harrison, Theodore, M.D.
- Study start
- 30 Jun 2017 (actual)
- Primary completion
- 31 May 2018 (estimated)
- Study completion
- 31 May 2018 (estimated)
- First posted
- 22 May 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.
This is a study to determine 1) the consistency of platelet-rich plasma produced by several methods, and 2) whether the platelet content of platelet-rich plasma can be accurately estimated from a baseline CBC platelet count.
Detailed description
In the first phase of this study a baseline CBC platelet count will be performed on each subject and then platelet-rich plasma (PRP) prepared from the same blood sample by six different methods. The platelet count will be measured in each PRP preparation and compared to the CBC platelet count to determine the platelet yield for each method.
In the second phase of the study a baseline CBC platelet count will be performed on each subject and then platelet-rich plasma (PRP) prepared from the same blood sample by six different methods. The CBC platelet count will be used to calculate the estimated platelet content of each sample/method based on the platelet yields determined in the first phase. The platelet count will be measured in each PRP preparation and compared to the estimated platelet content to determine the predictive accuracy for each method.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- normal adults
Key inclusion criteria (1 listed)
- English speaking
Key exclusion criteria (5 listed)
- platelet count < 150,000
- platelet count > 350,000
- History of blood disorder
- History of altered platelet function
- History of chemotherapy or radiation therapy
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 |
|---|---|---|
| venipunctureblood draw for the purpose of determining the platelet concentration in PRP | Procedure or surgery | – |
Primary outcome
Platelet yield
Time frame: within 8 hours of blood draw
the number of platelets in a PRP sample as a percentage of the number of platelets in the blood from which the PRP was prepared.
Platelet yield estimate accuracy
Time frame: within one month of final data collection
standard deviation of the difference between the estimated platelet yield and the actual platelet yield.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2017.
- Individual participant dataSharing planned: No
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.
Theodore E Harrison principal investigator
Theodore Harrison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Platelet-rich Plasma Production, run by Harrison, Theodore, M.D. at 1 site in Canada.
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 5 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 10 Aug 2017. 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 Canada. 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.
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?
Platelet yield (time frame: within 8 hours of blood draw). The study lists 2 primary outcomes in all. 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 10 Aug 2017.