Systemic Effects After Local Injection of Platelet-rich Plasma

NCT04456907 | Completed

• 1 other identifier: 6501714
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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).

Conditions

Platelet Rich Plasma (PRP)

Outcome Measures

Primary Outcomes (1)

• Urinary excretion of endogenous AAS metabolites

  Doping 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.

  1 week

Study Arms (2)

PPR group

EXPERIMENTAL

Receive PRP injection

Other: platelet rich plasma

Saline group

SHAM COMPARATOR

Receive saline injection

Other: saline injection

Interventions

platelet rich plasma OTHER

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.

PPR group

saline injection OTHER

saline injection

Saline group

Eligibility Criteria

• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Adult male athletes were diagnosed with tendinitis

You may not qualify if:

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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Medical Hosptial

Kaohsiung City, 833, Taiwan

Location

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2020
• First Posted: July 7, 2020
• Study Start: September 22, 2017
• Primary Completion: November 21, 2017
• Study Completion: March 28, 2018
• Last Updated: July 7, 2020

Record last verified: 2017-03

Locations

TW (1)