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Systemic Effects After Local Injection of Platelet-rich Plasma

Systemic Effects After Local Injection of Platelet-rich Plasma

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04456907
Enrollment
24
Registered
2020-07-07
Start date
2017-09-22
Completion date
2018-03-28
Last updated
2020-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Platelet Rich Plasma (PRP)

Brief 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).

Interventions

OTHERplatelet 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.

OTHERsaline injection

saline injection

Sponsors

Chang Gung Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
MALE
Healthy volunteers
Yes

Inclusion criteria

\- Adult male athletes were diagnosed with tendinitis

Exclusion criteria

* Receive local injections and surgery within three months * Systemic disease * Diagnosis of anemia

Design outcomes

Primary

MeasureTime frameDescription
Urinary excretion of endogenous AAS metabolites1 weekDoping substances in urine, mainly metabolites of anabolic androgenic steroids (AAS), were quantified, including testosterone (17β-hydroxyandrost-4-en-3-one), epitestosterone (17α- hydroxy-4-androsten-3-one), androsterone (4-androsten-3,17-dione), etiocholanolone (3α-hydroxy-5β-androstan-17-one), DHEA (dehydroepiandrosterone), dihydroandrosterone (5α- androstane-3α,17β-diol), and etiocholane-3α,17β-diol (5β -androstane-3α,17β-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.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026