UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057748 |
|---|---|
| Receipt number | R000065993 |
| Scientific Title | Standardizing Revolution per minute and Duration parameters for Platelet Rich Plasma preparation across Diverse Centrifuge Models: Towards Consensus Formation |
| Date of disclosure of the study information | 2025/06/01 |
| Last modified on | 2025/04/30 22:01:22 |
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Basic information
Public title
Finding the Best Settings to Prepare Platelet-Rich Plasma using Different Machines
Acronym
BSPRPDM
Scientific Title
Standardizing Revolution per minute and Duration parameters for Platelet Rich Plasma preparation across Diverse Centrifuge Models: Towards Consensus Formation
Scientific Title:Acronym
SRDPRP-DCM
Region
| Asia(except Japan) |
Condition
Condition
Platelet-Rich Plasma (PRP) Preparation Standardization
Classification by specialty
| Hematology and clinical oncology | Dermatology | Orthopedics |
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
o compare the platelet concentration achieved in PRP using different centrifuge models at varying RPM and time settings.
Basic objectives2
Others
Basic objectives -Others
To determine the influence of relative centrifugal force (RCF or g-force) in relation to rotor radius on PRP yield, and to propose a unified formula or conversion method that translates RPM into equivalent g-force across centrifuge models for PRP preparation.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Platelet Concentration in PRP will be measured using an automated hematology analyzer
Key secondary outcomes
Relative Centrifugal Force (RCF or g-force)will be calculated
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Healthy adult volunteers aged 18 to 60 years.
2. Individuals who provide written informed consent.
3. Participants with normal baseline complete blood count (CBC) parameters.
4. Non-smokers or light smokers (to reduce variables affecting blood quality).
5. Not currently on medications that affect platelet function (e.g., NSAIDs, antiplatelets, anticoagulants).
Key exclusion criteria
1. History of hematological disorders (e.g., thrombocytopenia, anemia, coagulopathies).
2. Active infection, inflammation, or chronic illness (e.g., diabetes, autoimmune disease).
3. Use of antiplatelet, anticoagulant, or anti-inflammatory medications within the last 7 days.
4. Pregnancy or breastfeeding.
5. Recent history of blood donation (within 8 weeks).
6. Inability or unwillingness to comply with study procedures.
Target sample size
1
Research contact person
Name of lead principal investigator
| 1st name | Syed Tameem |
| Middle name | |
| Last name | Ul Hassan |
Organization
Combined Military Hospital Kohat KPK Pakistan
Division name
Department of Physical Medicine and Rehabilitation
Zip code
26000
Address
Department of Physical Medicine and Rehabilitation, CMH Kohat, KPK, Pakistan
TEL
+923368885877
drtameem2@gmail.com
Public contact
Name of contact person
| 1st name | Syed Tameem |
| Middle name | |
| Last name | Ul Hassan |
Organization
Combined Military Hospital Kohat KPK Pakistan
Division name
Department of Physical Medicine and Rehabilitation
Zip code
26000
Address
Department of Physical Medicine and Rehabilitation, CMH Kohat, KPK, Pakistan
TEL
+923368885877
Homepage URL
drtameem2@gmail.com
Sponsor or person
Institute
Combined Military Hospital Kohat KPK Pakistan
Institute
Department
Personal name
Syed Tameem Ul Hassan
Funding Source
Organization
Combined Military Hospital Kohat KPK Pakistan
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Pakistan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Committee, Combined Military Hospital, Kohat, KPK, Pakistan
Address
CMH Kohat, KPK, Pakistan
Tel
+92922510262
tocmhkht@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
0
Results
Recruitment yet not started
Results date posted
| 2025 | Year | 04 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2025 | Year | 06 | Month | 01 | Day |
Baseline Characteristics
Study baseline characteristics will be shared
Participant flow
Participant flow will be shared
Adverse events
Adverse Events will be reported and shared
Outcome measures
Outcome measures will be shared
Plan to share IPD
Yes
IPD sharing Plan description
IPD will be shared via email to drtameem2@gmail.com.IPD will be shared with anyone interested including public and researchers.
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 05 | Month | 15 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 27 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 05 | Month | 21 | Day |
Date of closure to data entry
| 2025 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2025 | Year | 06 | Month | 01 | Day |
Other
Other related information
This observational study is a laboratory-based experimental investigation to standardize the centrifugation parameters, specifically revolutions per minute (RPM) and duration, for preparing Platelet-Rich Plasma (PRP) across various centrifuge models, that is, one with a fixed rotary angle and one with a swing bucket model. The study focuses on optimizing PRP preparation by examining the effects of different RPMs and duration combinations on platelet concentration, yield, and purity. Blood sample from a healthy volunteer will be processed using multiple centrifuge machines, allowing comparative analysis of relative centrifugal force (RCF) and its impact on PRP quality. The goal is to identify reproducible and effective PRP preparation parameters that can serve as a foundation for a universal protocol, thereby enhancing consistency in clinical and research applications of PRP.
Management information
Registered date
| 2025 | Year | 04 | Month | 30 | Day |
Last modified on
| 2025 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065993
