- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01553955
Efficacy of Training in Manual Preparation of Platelet Rich Plasma
July 22, 2013 updated by: Noel Peterson, N.D., Peterson, Noel, N.D.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Oregon
-
Lake Oswego, Oregon, United States, 97034
- Noel Peterson, N.D.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- English speaking medical practitioners(N.D., D.O. or M.D.)or their office staff
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
8 Hours After Onset of Training
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Retention of Platelet Concentration Ability At One Month.
Time Frame: Minimum 30 days after training day.
|
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.
|
Minimum 30 days after training day.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Noel Peterson, N.D., Noel Peterson, N.D.
- Study Chair: K. Dean Reeves, M.D., K. Dean Reeves, M.D., P.A.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (Actual)
January 1, 2013
Study Completion (Actual)
July 1, 2013
Study Registration Dates
First Submitted
February 7, 2012
First Submitted That Met QC Criteria
March 13, 2012
First Posted (Estimate)
March 14, 2012
Study Record Updates
Last Update Posted (Estimate)
July 24, 2013
Last Update Submitted That Met QC Criteria
July 22, 2013
Last Verified
March 1, 2012
More Information
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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