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Performance-Enhancing Effects of Platelet-Rich Plasma (PRP) Injections

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ClinicalTrials.gov Identifier: NCT01200875
Recruitment Status : Completed
First Posted : September 14, 2010
Results First Posted : December 6, 2016
Last Update Posted : August 6, 2018
Sponsor:
Collaborator:
Partnership for Clean Competition
Information provided by (Responsible Party):
Jason L. Dragoo, Stanford University

Tracking Information
First Submitted Date September 2, 2010
First Posted Date September 14, 2010
Results First Submitted Date October 12, 2016
Results First Posted Date December 6, 2016
Last Update Posted Date August 6, 2018
Study Start Date July 2010
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 12, 2016)		 Blood Growth Factor Concentrations [ Time Frame: 5 days following PRP injection ]
Original Primary Outcome Measures
 (submitted: September 13, 2010)		 Blood growth factor concentrations [ Time Frame: 5 days following PRP injection ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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
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.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Blood serum, blood plasma, and platelet-rich-plasma (PRP)
Sampling Method Non-Probability Sample
Study Population Patients receiving intramuscular or intratendinous platelet-rich-plasma (PRP) for treatment of muscle or tendon injury.
Condition
  • Tendinopathy
  • Rheumatic Diseases
Intervention
  • Procedure: Ultrasound-guided platelet-rich-plasma (PRP) injection
    One ultrasound-guided intratendinous or intramuscular PRP injection
  • Procedure: Platelet-Rich Plasma (PRP)
    One ultrasound-guided PRP injection
    Other Names:
    • PRP
    • Platelet Rich Plasma
    • Platelet-Rich-Plasma
Study Groups/Cohorts Not Provided
Publications * Wasterlain AS, Braun HJ, Harris AH, Kim HJ, Dragoo JL. The systemic effects of platelet-rich plasma injection. Am J Sports Med. 2013 Jan;41(1):186-93. doi: 10.1177/0363546512466383. Epub 2012 Dec 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 12, 2016)		 25
Original Estimated Enrollment
 (submitted: September 13, 2010)		 40
Actual Study Completion Date May 2013
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility 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
    • hypofibrinogenemia
    • anticoagulation medications
    • hypersensitivity to bovine products, which may be used for platelet activation.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01200875
Other Study ID Numbers SU-08032010-6646
18963 ( Other Identifier: Stanford IRB )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Jason L. Dragoo, Stanford University
Original Responsible Party Dr. Jason L. Dragoo, Stanford University School of Medicine
Current Study Sponsor Stanford University
Original Study Sponsor Same as current
Collaborators Partnership for Clean Competition
Investigators
Study Director: Dr. Christina Herrero New York University Langone Orthopedic Hospital
Principal Investigator: Dr. Jason L. Dragoo Stanford University
PRS Account Stanford University
Verification Date August 2018