Calculation of Platelet-rich Plasma Preparation Yield

Platelet-rich Plasma Production Clinical Trial

Official title:

Calculation of Platelet-rich Plasma Preparation Yield From Baseline CBC Platelet Count

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03161743
• Other study ID #: PRP Platelet Yield
• Status: Enrolling by invitation
• Phase: N/A
• First received: May 18, 2017
• Last updated: August 8, 2017
• Start date: June 30, 2017
• Est. completion date: May 31, 2018

Study information

• Verified date: August 2017
• Source: Harrison, Theodore, M.D.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: May 31, 2018
• Est. primary completion date: May 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Platelet-rich Plasma Production

Intervention

Procedure:
• venipuncture
blood draw for the purpose of determining the platelet concentration in PRP

Locations

Country	Name	City	State
Canada	Theodore E Harrison	Sidney	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Harrison, Theodore, M.D.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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