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
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
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
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
