UMIN-CTR Clinical Trial

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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