Systemic Effects After Local Injection of Platelet-rich Plasma

Platelet Rich Plasma (PRP) Clinical Trial

Official title:

Systemic Effects After Local Injection of Platelet-rich Plasma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04456907
• Other study ID #: 6501714
• Status: Completed
• Phase: N/A
• Start date: September 22, 2017
• Est. completion date: March 28, 2018

Study information

• Verified date: March 2017
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Objective Platelet-rich plasma (PRP) is widely utilized in the treatment of sports injuries with favorable outcomes. However, potential systemic effects after localized PRP injection are unclear at present.

Design: prospective randomized study Methods Twenty-four Taiwanese male athletes with tendinopathy were randomized into a PRP group (n = 13) or a saline group (n = 11).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 28, 2018
• Est. primary completion date: November 21, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: N/A and older

Eligibility

Inclusion Criteria

• Adult male athletes were diagnosed with tendinitis

Exclusion Criteria:

• Receive local injections and surgery within three months

• Systemic disease

• Diagnosis of anemia

Related Conditions & MeSH terms

• Platelet Rich Plasma (PRP)

Intervention

Other:
• platelet rich plasma
Autologous platelet-rich plasma (PRP) was prepared using the RegenKit THT system (RegenLab SA, Le Mont-sur-Lausanne, Switzerland) following the manufacturer's instructions. Medical technicians, who had been well-trained by the manufacturer, were responsible for the process of PRP preparation. For each patient, 8-10 mL of venous blood was drawn and collected to the commercial RegnLab THT tube, which contained 1 mL sodium citrate. After single centrifugation at 3400 revolutions per minute (rpm) for 8 minutes, 4-5 mL of PRP was yielded with leukocytes maintained at physiological levels and red blood cells depleted. Then, the blood components were separated, with the platelet pellet resting on the separating gel. PRP for later application was obtained by re-suspending the platelet pellet in the plasma supernatant by gently inverting the unopened RegenKit THT tube 5 to 10 times.
• saline injection
saline injection

Locations

Country	Name	City	State
Taiwan	Chang Gung Medical Hosptial	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary excretion of endogenous AAS metabolites	Doping substances in urine, mainly metabolites of anabolic androgenic steroids (AAS), were quantified, including testosterone (17ß-hydroxyandrost-4-en-3-one), epitestosterone (17a- hydroxy-4-androsten-3-one), androsterone (4-androsten-3,17-dione), etiocholanolone (3a-hydroxy-5ß-androstan-17-one), DHEA (dehydroepiandrosterone), dihydroandrosterone (5a- androstane-3a,17ß-diol), and etiocholane-3a,17ß-diol (5ß -androstane-3a,17ß-diol). Each urine sample (6 mL) was mixed with 50 µL standard solution and 1 mL phosphate buffer, and the mixture was heated for 60 min at 50°C. After cooling at room temperature, liquid-liquid extraction was performed, and phase separation was achieved. The organic extract was evaporated to dryness, and the dried residue was further derivatized with 50 µL of MSTFA solution for 30 min at 60°C. Finally, the sample was subjected to gas chromatographic analysis and mass spectrometric analysis for quantification of doping substances of interest.	1 week