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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000048549
Receipt No. R000055317
Scientific Title Bleeding risk of acupuncture for patients with hematological malignancies accompanying thrombocytopenia: A retrospective chart review
Date of disclosure of the study information 2022/08/02
Last modified on 2022/08/02

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Basic information
Public title Bleeding risk of acupuncture for patients with hematological malignancies accompanying thrombocytopenia: A retrospective chart review
Acronym Bleeding risk of acupuncture for patients with hematological malignancies accompanying thrombocytopenia: A retrospective chart review
Scientific Title Bleeding risk of acupuncture for patients with hematological malignancies accompanying thrombocytopenia: A retrospective chart review
Scientific Title:Acronym Bleeding risk of acupuncture for patients with hematological malignancies accompanying thrombocytopenia: A retrospective chart review
Region
Japan

Condition
Condition hematological malignancy
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the risk of bleeding from acupuncture in patients with hematological malignancies accompanying thrombocytopenia.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Occurrence of grade 2 or higher bleeding according to the Common Terminology Criteria for Adverse Events version 5.0 within 24 hours from the acupuncture session or before the next session
Key secondary outcomes

Base
Study type Observational

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Acupuncture sessions for patients with hematological malignancies who received acupuncture during hospitalization at the Department of Hematology, Aizu Medical Center, Fukushima Medical University between May 2013 and August 2021
Key exclusion criteria Acupuncture sessions that meet the following criteria.
・ Platelet count was not measured on the same day of acupuncture.
・ Platelet transfusions were performed on the same day before acupuncture.
・ The time of either acupuncture or platelet transfusion was unknown.
・ Non-penetrating acupuncture sessions (e.g., transcutaneous electrical acupoint stimulation) were performed.
Target sample size 51

Research contact person
Name of lead principal investigator
1st name Masao
Middle name
Last name Suzuki
Organization Aizu Medical Center, Fukushima Medical University
Division name Department of Kampo Medical Research Institute
Zip code 969-3492
Address 21-2 Maeda, Tanisawa, Kawahigashi, Aizuwakamatsu, Fukushima 969-3492, Japan
TEL 0242-75-2100
Email masuzuki@fmu.ac.jp

Public contact
Name of contact person
1st name Takumi
Middle name
Last name Kayo
Organization Aizu Medical Center, Fukushima Medical University
Division name Department of Kampo Medical Research Institute
Zip code 969-3492
Address 21-2 Maeda, Tanisawa, Kawahigashi, Aizuwakamatsu, Fukushima 969-3492, Japan
TEL 0242-75-2100
Homepage URL
Email k-takumi@fmu.ac.jp

Sponsor
Institute Fukushima Medical University
Institute
Department

Funding Source
Organization Fukushima Medical University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Fukushima Medical University
Address 1, Hikarigaoka, Fukushima, Japan
Tel 024-547-1825
Email rs@fmu.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
2022 Year 08 Month 02 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 51
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 Completed
Date of protocol fixation
2022 Year 02 Month 28 Day
Date of IRB
2022 Year 04 Month 15 Day
Anticipated trial start date
2022 Year 02 Month 28 Day
Last follow-up date
2022 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We will retrospectively investigate the medical records of patients with hematological malignancies who received acupuncture during hospitalization at a hematology department of a single medical center in Japan. The bleeding risk at the acupuncture site will be evaluated in the following 4 groups according to the platelet count measured on the day of acupuncture treatment: 1) less than 20,000/uL, 2) 20,000 to 49,000/uL, 3) 50,000 to 99,000/uL, and 4) 100,000/uL or more.

Management information
Registered date
2022 Year 08 Month 02 Day
Last modified on
2022 Year 08 Month 02 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055317

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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