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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | hematological malignancy | |
Classification by specialty |
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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 | |
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Interventions/Control_6 | |
Interventions/Control_7 | |
Interventions/Control_8 | |
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 | 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. |
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Target sample size | 51 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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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 | 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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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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 |
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Last modified on |
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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 |