UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038322
Receipt number R000043679
Scientific Title Effect of continuing anticoagulants and antiplatelet drugs on perioperative total blood loss in total hip replacement: a prospective observational study
Date of disclosure of the study information 2019/10/18
Last modified on 2019/10/17 19:03:38

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Basic information

Public title

Effect of continuing anticoagulants and antiplatelet drugs on perioperative total blood loss in total hip replacement: a prospective observational study

Acronym

Effect of continuing anticoagulants and antiplatelet drugs on perioperative total blood loss in total hip replacement: a prospective observational study

Scientific Title

Effect of continuing anticoagulants and antiplatelet drugs on perioperative total blood loss in total hip replacement: a prospective observational study

Scientific Title:Acronym

Effect of continuing anticoagulants and antiplatelet drugs on perioperative total blood loss in total hip replacement: a prospective observational study

Region

Japan


Condition

Condition

Osteoarthritis of the hip, rheumatoid arthritis, avascular necrosis of the femoral head

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigated the impact of continuing anticoagulants or antiplatelet drugs on perioperative blood loss in total hip arthroplasty.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The volume of perioperative blood loss measured using the calculated blood volume and change in hemoglobin from preoperative to postoperative day 4.

Key secondary outcomes

Complication


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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients undergoing total hip arthroplasty

Key exclusion criteria

Patients scheduled for revision total hip arthroplasty.
Patients scheduled for total hip arthroplasty with shortening subtrochanteric osteotomy.

Target sample size

500


Research contact person

Name of lead principal investigator

1st name Kenji
Middle name
Last name Kurosaka

Organization

Hokusuikai Kinen Hospital

Division name

Orthopaedic surgery

Zip code

310-0035

Address

3-2-1 Higashihara, Mito, Ibaraki, Japan

TEL

029-303-3003

Email

kenjikurosaka@yahoo.co.jp


Public contact

Name of contact person

1st name kenji
Middle name
Last name Kurosaka

Organization

Hokusuikai Kinen Hospital

Division name

Orthopaedic surgery

Zip code

310-0035

Address

3-2-1 Higashihara, Mito, Ibaraki, Japan

TEL

029-303-3003

Homepage URL


Email

kenjikurosaka@yahoo.co.jp


Sponsor or person

Institute

Hokusuikai Kinen Hospital

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

Hokusuikai Kinen Hospital

Address

3-2-1 Higashihara, Mito, Ibaraki, Japan

Tel

029-303-3003

Email

kenjikurosaka@yahoo.co.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

北水会記念病院 茨城県


Other administrative information

Date of disclosure of the study information

2019 Year 10 Month 18 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

Open public recruiting

Date of protocol fixation

2019 Year 04 Month 01 Day

Date of IRB

2019 Year 10 Month 03 Day

Anticipated trial start date

2019 Year 10 Month 03 Day

Last follow-up date

2022 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

perioperative total blood loss
Complication


Management information

Registered date

2019 Year 10 Month 17 Day

Last modified on

2019 Year 10 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043679


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name