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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Enrolling by invitation |
Unique ID issued by UMIN | UMIN000029278 |
Receipt No. | 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 | 2018/01/17 |
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 |
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Condition | |||
Condition | muscle strain | ||
Classification by specialty |
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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 |
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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 | ||
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Interventions/Control_7 | ||
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Interventions/Control_9 | ||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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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 |
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Organization | University of Tsukuba | ||||||
Division name | Department of Orthopaedics Surgery, Faculty of Medicine | ||||||
Zip code | |||||||
Address | 1-1-1 Tennodai, Tsukuba, Ibaraki, 305-8575, Japan | ||||||
TEL | +81298533219 | ||||||
masashiy@md.tsukuba.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | University of tsukuba | ||||||
Division name | Division of Regenerative Medicine for Musculoskeletal System | ||||||
Zip code | |||||||
Address | 1-1-1 Tennodai, Tsukuba, Ibaraki, 305-8575, Japan | ||||||
TEL | +81298533219 | ||||||
Homepage URL | |||||||
tymd99@tsukuba-seikei.jp |
Sponsor | |
Institute | Department of Orthopaedics Surgery, Faculty of Medicine, University of Tsukuba |
Institute | |
Department |
Funding Source | |
Organization | Grant of Japan Sports Medicine Foundation 2016 |
Organization | |
Division | |
Category of Funding Organization | Non profit foundation |
Nationality of Funding Organization |
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IRB Contact (For public release) | |
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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 |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | |
Results | |
Results date posted | |
Results Delayed | |
Results Delay Reason | |
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Baseline Characteristics | |
Participant flow | |
Adverse events | |
Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Enrolling by invitation | ||||||
Date of protocol fixation |
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Anticipated trial start date |
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Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.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 |