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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025066
Receipt No. R000028838
Scientific Title The association between ABO blood group and polypharmacy: does blood group O have an affinity for medications? A retrospective and prospective cross-sectional study.
Date of disclosure of the study information 2016/11/30
Last modified on 2019/06/06

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Basic information
Public title The association between ABO blood group and polypharmacy: does blood group O have an affinity for medications? A retrospective and prospective cross-sectional study.
Acronym The association between ABO blood group and polypharmacy
Scientific Title The association between ABO blood group and polypharmacy: does blood group O have an affinity for medications? A retrospective and prospective cross-sectional study.
Scientific Title:Acronym The association between ABO blood group and polypharmacy
Region
Japan

Condition
Condition polypharmacy in elderly patients
Classification by specialty
Hematology and clinical oncology Geriatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate whether blood group O exhibits greater rates of polypharmacy compared with other blood groups
Basic objectives2 Others
Basic objectives -Others To evaluate whether blood group O is less likely to undergo deprescription for polypharmacy than other blood groups.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the difference between blood group O and non-O blood groups in the proportion of polypharmacy at admission
Key secondary outcomes the difference between blood group O and non-O blood groups in the rate of refusal to undergo deprescription during the hospital stay

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
65 years-old <=
Age-upper limit
110 years-old >=
Gender Male and Female
Key inclusion criteria Inclusion criteria for primary objective
1) Hip fracture patients aged 65 years or older

Inclusion criteria for secondary objective
1) Patients aged 65 years or older hospitalized for orthopaedic reasons
2) Five or more prescribed medications at admission
3) Pharmacists explained and recommended the interventions to improve polypharmacy
Key exclusion criteria Exclusion criteria for primary objective
1) A second admission due to a hip fracture during the study period
2) Hip fracture was not confirmed by X-ray after admission
3) ABO blood typing was not performed

Exclusion criteria for secondary objective
1) A second or third contact by pharmacists during another admission
2) ABO blood typing was not performed
Target sample size 340

Research contact person
Name of lead principal investigator
1st name Junpei
Middle name
Last name Komagamine
Organization National Hospital Organization Tochigi Medical Center
Division name Internal medicine
Zip code 3208580
Address 1-10-37, Nakatomatsuri, Utsunomiya, Tochigi 320-8580, Japan
TEL 028-622-5241
Email jkomagamine@tochigi-mc.jp

Public contact
Name of contact person
1st name Junpei
Middle name
Last name Komagamine
Organization National Hospital Organization Tochigi Medical Center
Division name Internal medicine
Zip code 3208580
Address 1-10-37, Nakatomatsuri, Utsunomiya, Tochigi 320-8580, Japan
TEL 028-622-5241
Homepage URL
Email jkomagamine@tochigi-mc.jp

Sponsor
Institute National Hospital Organization Tochigi Medical Center
Institute
Department

Funding Source
Organization None
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 National Hospital Organization Tochigi Medical Center
Address 1-10-37, Nakatomatsuri, Utsunomiya, Tochigi 320-8580, Japan
Tel 028-622-5241
Email atamura@tochigi-mc.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 独立行政法人国立病院機構栃木医療センター(栃木県)

Other administrative information
Date of disclosure of the study information
2016 Year 11 Month 30 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
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
2016 Year 11 Month 25 Day
Date of IRB
2017 Year 01 Month 17 Day
Anticipated trial start date
2017 Year 01 Month 01 Day
Last follow-up date
2017 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This study is a retrospective and prospective observational study at a single centre and consists of two major components:
1) A cross-sectional study to evaluate the association between ABO blood group and polypharmacy among elderly hip fracture patients
2) A cross-sectional study to investigate whether a person of blood group O is more likely to refuse deprescription among elderly orthopaedic patients prescribed 5 or more medications at admission
Cases will be included if the admission date of patients was after 1 January 2015. We will also include cases prospectively until 31 May 2017.

Management information
Registered date
2016 Year 11 Month 30 Day
Last modified on
2019 Year 06 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028838

Research Plan
Registered date File name
2017/01/02 ABO blood group protocol.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name


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