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History of Changes for Study: NCT01200875
Performance-Enhancing Effects of Platelet-Rich Plasma (PRP) Injections
Latest version (submitted August 2, 2018) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 September 13, 2010 None (earliest Version on record)
2 June 10, 2011 Study Identification, Groups and Interventions, Study Status, Eligibility and Oversight
3 October 12, 2016 Recruitment Status, Study Status, Sponsor/Collaborators, Contacts/Locations, Study Design, Results and Outcome Measures
4 December 7, 2016 Outcome Measures, Study Status, Baseline Characteristics and Participant Flow
5 August 2, 2018 Contacts/Locations, Study Status and Baseline Characteristics
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Study NCT01200875
Submitted Date:  September 13, 2010 (v1)

Open or close this module Study Identification
Unique Protocol ID: SU-08032010-6646
Brief Title: Performance-Enhancing Effects of Platelet-Rich Plasma (PRP) Injections
Official Title: Effect of Intramuscular and Intratendinous Platelet-Rich Plasma Injections on Systemic Concentrations of Performance-Enhancing Growth Factors
Secondary IDs: 18963 (Stanford IRB Protocol)
Open or close this module Study Status
Record Verification: September 2010
Overall Status: Recruiting
Study Start: July 2010
Primary Completion: January 2012 [Anticipated]
Study Completion: July 2012 [Anticipated]
First Submitted: September 2, 2010
First Submitted that
Met QC Criteria:
September 13, 2010
First Posted: September 14, 2010 [Estimate]
Last Update Submitted that
Met QC Criteria:
September 13, 2010
Last Update Posted: September 14, 2010 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Stanford University
Responsible Party:
Collaborators: Partnership for Clean Competition
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
Brief Summary:

Platelet-Rich Plasma (PRP) has been banned in competitive athletes because some people think it may enhance athletic performance. However, there is very little published research to support or undermine this point of view. The purposes of this study are: (1) To assess the effects of local platelet-rich plasma (PRP) therapy on systemic levels of growth factors with suspected or known performance-enhancing effects; and (2) To understand whether the effect of PRP therapy on these growth factors differs between intramuscular and intratendinous PRP injections.

This research study is looking for 40 people who are receiving platelet-rich plasma therapy for a tendon or muscle injury. The study involves collecting seven blood samples (2 teaspoons each) from each patient, before and after the PRP treatment. Blood samples may be donated at any location of the patient's choosing, and participants will be paid for their time.

Detailed Description:

To understand the short-term systemic effects of local PRP injections, we will measure the serum concentrations of six growth factors before and during the four days following PRP injection: human growth hormone (hGH), IGF-1, basic FGF, PDGF-BB, VEGF, and IGFBP-3. These molecules are of particular interest because they may have stimulatory effects that enhance athletic performance, and because they have been banned in competitive athletes by the World Anti-Doping Agency (WADA).

We aim to recruit 40 patients who are receiving ultrasound-guided intratendinous (IT) or intramuscular (IM) PRP injections. Blood will be drawn immediately before (baseline); 15 minutes after; and 3, 24, 48, 72 and 96 hours after receiving PRP therapy. A fraction of the therapeutic PRP preparation will be isolated for growth factor analysis. Serum concentrations of growth factors will be quantified by ELISA. Statistical analyses will be conducted to assess the change in each growth factor following PRP injection. To understand the impact of injection site on systemic growth factors, changes in concentration will also be compared between the intratendinous and intramuscular groups.

Study subjects will participate in the following steps: (1) Initial diagnostic visit with Orthopaedic Surgeon, (2) Blood collection as part of PRP therapy, (3) Ultrasound-guided PRP therapy administered by Stanford radiologist, and (4) Blood collection for the study. Steps (1) through (3) are all part of the standard of care, which the patient will have chosen independently of the study. In step (4), blood samples will be collected by venipuncture at various time points and assayed for growth factor concentrations. Less than 10 mL (2 teaspoons) of blood will be collected at each of seven time points over five consecutive days. In order to minimize inconvenience to the patient we will meet patients at a location of their choosing, such as the patient's home or office, for blood collection on days 2-5. Participants will be compensated after all seven blood samples have been donated.

Open or close this module Conditions
Conditions: Tendinopathy
Rheumatic Diseases
Keywords: PRP
platelet rich plasma
platelet
growth hormone
tendonitis
tendinosis
tendinopathy
enthesopathy
muscle
sport
tendon
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Case-Only
Time Perspective: Prospective
Biospecimen Retention: Samples Without DNA
Biospecimen Description: Blood serum, blood plasma, and platelet-rich-plasma (PRP)
Enrollment: 40 [Anticipated]
Number of Groups/Cohorts 0
Open or close this module Groups and Interventions
Intervention Details:
Procedure: Ultrasound-guided platelet-rich-plasma (PRP) injection
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Blood growth factor concentrations
[ Time Frame: 5 days following PRP injection ]

Open or close this module Eligibility
Study Population: Patients receiving intramuscular or intratendinous platelet-rich-plasma (PRP) for treatment of muscle or tendon injury.
Sampling Method: Non-Probability Sample
Minimum Age:
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Male and female patients 18-50 years old, receiving ultrasound-guided intratendinous or intramuscular PRP injections

Exclusion Criteria:

  • History of cancer, diabetes, hormone-replacement therapy, or abnormal nutritional habits.
  • Contraindications for PRP therapy itself:
    • preexisting coagulation defects including thrombocytopenia
    • hypofibrinoginemia
    • anticoagulation medications
    • hypersensitivity to bovine products, which may be used for platelet activation.
Open or close this module Contacts/Locations
Central Contact Person: Amy S Wasterlain
Telephone: (718) 644-5731
Email: awasterl@stanford.edu
Study Officials: Amy Sarah Wasterlain
Sub-Investigator
Stanford University
Dr. Jason L. Dragoo
Principal Investigator
Stanford University
Locations: United States, California
Stanford University School of Medicine
[Recruiting]
Stanford, California, United States, 94305
Contact:Contact: Amy S Wasterlain 718-644-5731 awasterl@stanford.edu
Contact:Principal Investigator: Dr. Jason L. Dragoo
Contact:Sub-Investigator: Amy Sarah Wasterlain
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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