UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029278
Receipt number R000033463
Scientific Title Safety of platelet rich plasma injection for muscle strain
Date of disclosure of the study information 2017/11/01
Last modified on 2021/10/05 05:56:27

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Basic information

Public title

Safety of platelet rich plasma injection for muscle strain

Acronym

Safety of platelet rich plasma injection for muscle strain

Scientific Title

Safety of platelet rich plasma injection for muscle strain

Scientific Title:Acronym

Safety of platelet rich plasma injection for muscle strain

Region

Japan


Condition

Condition

muscle strain

Classification by specialty

Orthopedics Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To ascertain the safety of platelet-rich plasma injection for patients who received muscle strain diagnosed as Okuwaki classification grade 2.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Phase I,II


Assessment

Primary outcomes

Adverse events occurring during platelet-rich plasma use and observation period and its details

Key secondary outcomes

Clinical outcome after using platelet-rich plasma, time course change with MRI


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

For patients diagnosed as Okuwaki classification type II by MRI, Platelet-rich plasma is infiltrated to the muscle injured area under ultrasound guided within 7 days after injury

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.acute muscle strain
2.Patients diagnosed with Okuwaki classification type II by taking for MRI
3.Be able to treat under ultrasound guidance at our hospital within 1 week after injury
4.Be observable throughout the entire research period

Key exclusion criteria

a history of infectious disease and systemic disorders such as diabetes, rheumatoid arthritis, hematological diseases (coagulopathy), severe cardiovascular diseases, infections, or immunodepression; therapy with anticoagulants or an anti-aggregating agent; use of non-steroidal anti-inflammatory drugs 2 weeks before blood sampling; and hemoglobin levels <10 g/dL.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Yamazaki
Middle name
Last name Masashi

Organization

University of Tsukuba

Division name

Department of Orthopaedics Surgery, Faculty of Medicine

Zip code

305-8575

Address

1-1-1 Tennodai, Tsukuba, Ibaraki, 305-8575, Japan

TEL

+81298533219

Email

masashiy@md.tsukuba.ac.jp


Public contact

Name of contact person

1st name Tmokazu
Middle name
Last name Yoshioka

Organization

University of tsukuba

Division name

Division of Regenerative Medicine for Musculoskeletal System

Zip code

305-8575

Address

1-1-1 Tennodai, Tsukuba, Ibaraki, 305-8575, Japan

TEL

+81298533219

Homepage URL


Email

tymd99@tsukuba-seikei.jp


Sponsor or person

Institute

Department of Orthopaedics Surgery, Faculty of Medicine, University of Tsukuba

Institute

Department

Personal name



Funding Source

Organization

Grant of Japan Sports Medicine Foundation 2016

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Tsukuba Clinical Research and Development Organization

Address

2-1-1 Amakubo, Tsukuba, Ibaraki, Japan

Tel

0298533914

Email

t-credo.adm@un.tsukuba.ac.jp


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

2017 Year 11 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


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Terminated

Date of protocol fixation

2017 Year 09 Month 20 Day

Date of IRB

2017 Year 09 Month 20 Day

Anticipated trial start date

2017 Year 12 Month 01 Day

Last follow-up date

2020 Year 12 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 09 Month 25 Day

Last modified on

2021 Year 10 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033463


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name