UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000048549
Receipt number 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 15:16:56

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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 or person

Institute

Fukushima Medical University

Institute

Department

Personal name



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

Value
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