NCT01553955

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 7, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 14, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

July 24, 2013

Status Verified

March 1, 2012

Enrollment Period

1 year

First QC Date

February 7, 2012

Last Update Submit

July 22, 2013

Conditions

Platelet Rich Plasma Production

Keywords

PRP,PlateletManual

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Retention of Platelet Concentration Ability At One Month.

    Minimum 30 days after training day.

Interventions

VenipuncturePROCEDURE

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.

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • English speaking medical practitioners(N.D., D.O. or M.D.)or their office staff

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Noel Peterson, N.D.

Lake Oswego, Oregon, 97034, United States

Location

MeSH Terms

Interventions

Phlebotomy

Intervention Hierarchy (Ancestors)

Blood Specimen CollectionSpecimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesTherapeuticsSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Noel Peterson, N.D.

    Noel Peterson, N.D.

    PRINCIPAL INVESTIGATOR

  • K. Dean Reeves, M.D.

    K. Dean Reeves, M.D., P.A.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
INDIV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 7, 2012

First Posted

March 14, 2012

Study Start

January 1, 2012

Primary Completion

January 1, 2013

Study Completion

July 1, 2013

Last Updated

July 24, 2013

Record last verified: 2012-03

Locations

US(1)