Calculation of Platelet-rich Plasma Preparation Yield

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.

Study Overview

• Status: Unknown
• Conditions: Platelet-rich Plasma Production
• Intervention / Treatment: Procedure: venipuncture

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 Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Sidney, British Columbia, Canada, V8L5K1
      • Theodore E Harrison

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

normal adults

Description

Inclusion Criteria:

• English speaking

Exclusion Criteria:

• platelet count < 150,000
• platelet count > 350,000
• History of blood disorder
• History of altered platelet function
• History of chemotherapy or radiation therapy

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	within one month of final data collection

Collaborators and Investigators

• Sponsor: Harrison, Theodore, M.D.
• Investigators: Principal Investigator: Theodore E Harrison, Theodore Harrison

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 30, 2017
• Primary Completion (ANTICIPATED): May 31, 2018
• Study Completion (ANTICIPATED): May 31, 2018

Study Registration Dates

• First Submitted: May 18, 2017
• First Submitted That Met QC Criteria: May 18, 2017
• First Posted (ACTUAL): May 22, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 10, 2017
• Last Update Submitted That Met QC Criteria: August 8, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: platelet; platelet-rich plasma
• Other Study ID Numbers: PRP Platelet Yield

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No