UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027386
Receipt number R000031315
Scientific Title Efficacy of body temperature management during thoracic endovascular aortic repair
Date of disclosure of the study information 2017/05/31
Last modified on 2019/10/31 08:37:51

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Basic information

Public title

Efficacy of body temperature management during thoracic endovascular aortic repair

Acronym

Body temperature during TEVAR

Scientific Title

Efficacy of body temperature management during thoracic endovascular aortic repair

Scientific Title:Acronym

Body temperature during TEVAR

Region

Japan


Condition

Condition

Stanford type B aortic dissection
Thoracic aortic aneurysm

Classification by specialty

Vascular surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Our conventional body temperature management during thoracic endovascular aortic repair includes systemic warming using a warming blanket (Bair Hugger (R)). We introduced an additional procedure using a cast padding (ortho-wrap(R)) and a drape equipped with Bair Hugger to maintain lower limb temperature.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Incidence of silvering from the start of operation to exit from an operation room

Key secondary outcomes

1, distal temperature at the end of operation
2, central temperature at the end of operation
3, operation time, outcome, duration of hospital stay, complication


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

with a cast padding and a drape

Interventions/Control_2

without a cast padding and a drape

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1, patients undergoing TEVAR for Stanford type B aortic dissection or thoracic aortic aneurysm
2, age more than 20 years old
3, patients obtained informed consent

Key exclusion criteria

1, patients requiring debranch TEVAR (TEVAR with surgical bypass)
2, emergency operation
3, patients with peripheral arterial disease (bilateral or unilateral)

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Eri Mishima

Organization

Hiroshima University Hospital

Division name

Surgical operation

Zip code


Address

Kasumi.1-2-3,minamiku,Hiroshima,Jpan

TEL

082-257-5530

Email

eri-ebi11@hiroshima-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Eri Mishima

Organization

Hiroshima University Hospital

Division name

Surgical operation

Zip code


Address

Kasumi.1-2-3,minamiku,Hiroshima,Japan

TEL

082-257-5530

Homepage URL


Email

eri-ebi11@hiroshima-u.ac.jp


Sponsor or person

Institute

Hiroshima University Hospital
Department of nursing
Department of operation

Institute

Department

Personal name



Funding Source

Organization

Hiroshima University Hospital
Department of nursing
Department of operation

Organization

Division

Category of Funding Organization

Other

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

2017 Year 05 Month 31 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

Terminated

Date of protocol fixation

2017 Year 02 Month 01 Day

Date of IRB

2017 Year 04 Month 29 Day

Anticipated trial start date

2017 Year 06 Month 01 Day

Last follow-up date

2018 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 05 Month 18 Day

Last modified on

2019 Year 10 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031315


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name