NCT01200875

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2010

Typical duration for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 2, 2010

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 14, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
3.6 years until next milestone

Results Posted

Study results publicly available

December 6, 2016

Completed
Last Updated

August 6, 2018

Status Verified

August 1, 2018

Enrollment Period

1.4 years

First QC Date

September 2, 2010

Results QC Date

October 12, 2016

Last Update Submit

August 2, 2018

Conditions

TendinopathyRheumatic Diseases

Keywords

PRPplatelet rich plasmaplateletgrowth hormonetendonitistendinosistendinopathyenthesopathymusclesporttendon

Outcome Measures

Primary Outcomes (1)

  • Blood Growth Factor Concentrations

    5 days following PRP injection

Interventions

Ultrasound-guided platelet-rich-plasma (PRP) injectionPROCEDURE

One ultrasound-guided intratendinous or intramuscular PRP injection

Platelet-Rich Plasma (PRP)PROCEDURE

One ultrasound-guided PRP injection

Also known as: PRP, Platelet Rich Plasma, Platelet-Rich-Plasma

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients receiving intramuscular or intratendinous platelet-rich-plasma (PRP) for treatment of muscle or tendon injury.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University Langone Orthopedic Hospital

New York, New York, 10010, United States

Location

Related Publications (1)

  • 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.

    PMID: 23211708DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood serum, blood plasma, and platelet-rich-plasma (PRP)

MeSH Terms

Conditions

TendinopathyRheumatic DiseasesEnthesopathy

Interventions

Injections

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesTendon InjuriesWounds and InjuriesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeutics

Results Point of Contact

Title
Jason Dragoo, Associate Professor
Organization
Stanford University
jdragoo@stanford.edu
(650) 721-3430

Study Officials

  • Dr. Christina Herrero

    New York University Langone Orthopedic Hospital

    STUDY DIRECTOR

  • Dr. Jason L. Dragoo

    Stanford University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 2, 2010

First Posted

September 14, 2010

Study Start

July 1, 2010

Primary Completion

December 1, 2011

Study Completion

May 1, 2013

Last Updated

August 6, 2018

Results First Posted

December 6, 2016

Record last verified: 2018-08

Locations

US(1)