UMIN-CTR Clinical Trial

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

polypharmacy in elderly patients

Classification by specialty

Hematology and clinical oncology

Geriatrics

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

National Hospital Organization Tochigi Medical Center

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

独立行政法人国立病院機構栃木医療センター(栃木県)

Date of disclosure of the study information

2016

Year

11

Month

30

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

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