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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01553955
Other study ID # ManualPRP
Secondary ID
Status Completed
Phase N/A
First received February 7, 2012
Last updated July 22, 2013
Start date January 2012
Est. completion date July 2013

Study information

Verified date March 2012
Source Peterson, Noel, N.D.
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date July 2013
Est. primary completion date January 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 21 Years to 80 Years
Eligibility 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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

Procedure:
Venipuncture
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.

Locations

Country Name City State
United States Noel Peterson, N.D. Lake Oswego Oregon

Sponsors (1)

Lead Sponsor Collaborator
Peterson, Noel, N.D.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 8 Hours After Onset of Training No
Secondary 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. Minimum 30 days after training day. No