UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003350
Receipt number R000004067
Scientific Title Examination of utility of prevention and screening tests for pulmonary embolism and deep venus trombosis after total joint replacementof inferior limb.
Date of disclosure of the study information 2010/04/01
Last modified on 2010/03/17 20:38:21

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Basic information

Public title

Examination of utility of prevention and screening tests for pulmonary embolism and deep venus trombosis after total joint replacementof inferior limb.

Acronym

Prevention and screening tests after totaj joint replacement.

Scientific Title

Examination of utility of prevention and screening tests for pulmonary embolism and deep venus trombosis after total joint replacementof inferior limb.

Scientific Title:Acronym

Prevention and screening tests after totaj joint replacement.

Region

Japan


Condition

Condition

All patients who do total hip replacement and total knee replacement.

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We hold anticoagulant therapy to postoperative patients who had THA or TKA, and cofirm this thrombotic protective effects.
In addition, we screen thrombotic presence by blood examination, and review the utility.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Utility of screening tests(FDP D-dimer,Solible fibrine monomer complex)
,thrombotic protective effects of anticoagulation.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Prevention

Type of intervention

Medicine Maneuver

Interventions/Control_1

We hold anticoagulant therapy with hypodermic injection of heparin in post operative all cases.heparin is chosen among three kinds at randam(Caprocin, arixtra, CLEXANE).Injections continues for two weeks.

Interventions/Control_2

We do vein of lower extremity echo check on preoperative, post operative 7th, 14th.

Interventions/Control_3

We measures FDP D-dimer by blood examination on postoperative 1st, 3rd, 5th, 7th, 10th and 14th.
In addition, we measures SFMC in preoperative, postoperative 24 hours, 7th day and 14th day.

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

The all cases which do THA or TKA in this hospital.

Key exclusion criteria

The patients who has the basal disease that anticoagulation cannot do.

Target sample size

300


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroyuki Kodaira

Organization

Shinshu university school of medicine

Division name

Department of orthopaedic surgery

Zip code


Address

3-1-1 Asahi Matumoto-shi Nagano 390-8621 JAPAN

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

shinshu university school

Division name

Department of orthopaedic surgery

Zip code


Address


TEL

0263-37-2659

Homepage URL


Email



Sponsor or person

Institute

Department of prthopaedic surgery Shinshu university school of medicine

Institute

Department

Personal name



Funding Source

Organization

Department of prthopaedic surgery Shinshu university school of medicine

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


Address


Tel


Email



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

2010 Year 04 Month 01 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

Enrolling by invitation

Date of protocol fixation

2010 Year 04 Month 01 Day

Date of IRB


Anticipated trial start date

2010 Year 05 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2010 Year 03 Month 17 Day

Last modified on

2010 Year 03 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004067


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name