UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025066
Receipt number 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 18:36:47

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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 or person

Institute

National Hospital Organization Tochigi Medical Center

Institute

Department

Personal name



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

Value
https://center6.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