Platelet Rich Plasma (PRP)NCT04456907
Systemic Effects After Local Injection of Platelet-rich Plasma
A study testing platelet rich plasma and saline injection in people with Platelet Rich Plasma (PRP), run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Any age, men onlyHealthy volunteers can take part
- Conditions the study is for
- Platelet Rich Plasma (PRP)
- What is being tested?
- platelet rich plasma and saline injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteTaiwan
- Study dates
- 22 Sep 2017to 28 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Adult male athletes were diagnosed with tendinitis
Who cannot join
- Receive local injections and surgery within three months
- Systemic disease
- Diagnosis of anemia
Trial locations and contacts
1 site in 1 country.
About this study
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)
- Being tested
- platelet rich plasma, saline injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
platelet rich plasmaOther
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 injectionOther
saline injection
| Study group | Role | What they receive |
|---|---|---|
| PPR group | Experimental | Receive PRP injection Receives: Other: platelet rich plasma |
| Saline group | Sham comparator | Receive saline injection Receives: Other: saline injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start22 Sep 2017
- Primary completion21 Nov 2017
- Study completion28 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Platelet Rich Plasma (PRP)Studies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04456907
- Sponsor's protocol ID
- 6501714
- Status last verified
- Mar 2017
- First submitted
- 2 Jun 2020
- Last updated
- 7 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic Effects After Local Injection of Platelet-rich Plasma
- ClinicalTrials.gov ID
- NCT04456907
- Acronym / sponsor ID
- 6501714
- Conditions
- Platelet Rich Plasma (PRP)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 22 Sep 2017 (actual)
- Primary completion
- 21 Nov 2017 (actual)
- Study completion
- 28 Mar 2018 (actual)
- First posted
- 7 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PPR group | Experimental | Other: platelet rich plasmaReceive PRP injection |
| Saline group | Sham comparator | Other: saline injectionReceive saline injection |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Adult male athletes were diagnosed with tendinitis
Key exclusion criteria (3 listed)
- Receive local injections and surgery within three months
- Systemic disease
- Diagnosis of anemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| platelet rich plasmaAutologous 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. | Other | PPR group |
| saline injectionsaline injection | Other | Saline group |
Primary outcome
Urinary excretion of endogenous AAS metabolites
Time frame: 1 week
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing platelet rich plasma and saline injection in people with Platelet Rich Plasma (PRP), run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary excretion of endogenous AAS metabolites (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2020.