Platelet Rich Plasma ProductionNCT01553955
Efficacy of Training in Manual Preparation of Platelet Rich Plasma
A study testing Venipuncture in people with Platelet Rich Plasma Production, run by Peterson, Noel, N.D. at 1 site in United States.
Trial summary
This is a device study in some respects, in that specialized centrifuges are commonly used to make platelet rich plasma, and we are studying the use of standard laboratory equipment to do so. 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
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Jul 2013
- Phase
- Interventional
- 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
Who may be able to join
- English speaking medical practitioners(N.D., D.O. or M.D.)or their office staff
Who cannot join
- History of difficult blood draws
- Platelet count < 150,000
- Hb < 37%
- 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: Efficacy of Training in Preparation of Platelet Rich Plasma Using a Standard Centrifuge and Manual Pipetting Methods
This is a device study in some respects, in that specialized centrifuges are commonly used to make platelet rich plasma, and we are studying the use of standard laboratory equipment to do so. However, it is primarily interventional in that we will evaluate the percentage success of trainees in the concentration of viable platelets to more than 4X baseline using a generic speed centrifuge and a single spin method.
- Conditions
- Platelet Rich Plasma Production
- Being tested
- Venipuncture
- Keywords
- PRP,, Platelet, Manual
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 purposes of training in platelet rich plasma concentration. Trainees will be in pairs and each will draw blood from the other for use in the concentration process.
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet Concentration Ability After 8 Hours of Training.
Evaluate the percentage success of trainees in the concentration of viable platelets to more than 4X baseline using a generic speed centrifuge and a single spin method. The number evaluated to determine success will be the average concentration ratio achieved in three consecutive concentrations.
Measured: 8 Hours After Onset of Training
Secondary outcomes (1)
Retention of Platelet Concentration Ability At One Month.
Evaluate the percentage success of trainees in the concentration of viable platelets to more than 4X baseline using a generic speed centrifuge and a single spin method. The number evaluated to determine success will be the average concentration ratio achieved in three consecutive concentrations performed 30 days or longer after the training day.
Measured: Minimum 30 days after training day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2012 (estimated)
- Study startJan 2012
- Primary completionJan 2013
- Study completionJul 2013
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peterson, Noel, N.D.
- Responsible party
- Principal investigator, Noel Peterson, N.D., Peterson, Noel, N.D.
- Investigators
- Noel Peterson, N.D., Principal investigator, Noel Peterson, N.D.K. Dean Reeves, M.D., Study chair, K. Dean Reeves, M.D., P.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01553955
- Sponsor's protocol ID
- ManualPRP
- Status last verified
- Mar 2012
- First submitted
- 7 Feb 2012
- Last updated
- 24 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Training in Preparation of Platelet Rich Plasma Using a Standard Centrifuge and Manual Pipetting Methods
- ClinicalTrials.gov ID
- NCT01553955
- Acronym / sponsor ID
- ManualPRP
- Conditions
- Platelet Rich Plasma Production
- Keywords
- PRP,, Platelet, Manual
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Peterson, Noel, N.D.
- Study start
- Jan 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 14 Mar 2012 (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 device study in some respects, in that specialized centrifuges are commonly used to make platelet rich plasma, and we are studying the use of standard laboratory equipment to do so. However, it is primarily interventional in that we will evaluate the percentage success of trainees in the concentration of viable platelets to more than 4X baseline using a generic speed centrifuge and a single spin method.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- English speaking medical practitioners(N.D., D.O. or M.D.)or their office staff
Key exclusion criteria (6 listed)
- History of difficult blood draws
- Platelet count < 150,000
- 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 purposes of training in platelet rich plasma concentration. Trainees will be in pairs and each will draw blood from the other for use in the concentration process. | Procedure or surgery | – |
Primary outcome
Platelet Concentration Ability After 8 Hours of Training.
Time frame: 8 Hours After Onset of Training
Evaluate the percentage success of trainees in the concentration of viable platelets to more than 4X baseline using a generic speed centrifuge and a single spin method. The number evaluated to determine success will be the average concentration ratio achieved in three consecutive concentrations.
1 secondary outcome
Retention of Platelet Concentration Ability At One Month.
Time frame: Minimum 30 days after training day.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2013.
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.
Noel Peterson, N.D. principal investigator
Noel Peterson, N.D.
K. Dean Reeves, M.D. study chair
K. Dean Reeves, M.D., P.A.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Venipuncture in people with Platelet Rich Plasma Production, run by Peterson, Noel, N.D. 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 1 inclusion and 6 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: finished, as of the sponsor's last update on 24 Jul 2013. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Concentration Ability After 8 Hours of Training. (time frame: 8 Hours After Onset of Training). 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 24 Jul 2013.