UMIN-CTR Clinical Trial

Public title

Predicting the occurrence of gluteal necrosis with near-infrared spectroscopy in pelvic fracture cases: A multicenter study

Acronym

Prediction of occurrence of gluteal necrosis in pelvic fracture cases

Scientific Title

Predicting the occurrence of gluteal necrosis with near-infrared spectroscopy in pelvic fracture cases: A multicenter study

Scientific Title:Acronym

Prediction of occurrence of gluteal necrosis in pelvic fracture cases

Region

Japan

Condition

pelvic fracture

Classification by specialty

Radiology

Emergency medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Near-infrared spectroscopy (NIRS) is minimally invasive and enables successive measurement of oxygen saturation of hemoglobin in vivo. With real-time calculation of regional oxygen saturation (rSO2) under the sensor, NIRS can detect early decreased blood flow or ischemic conditions. This study is to evaluate the efficacy of NIRS for predicting the occurrence of gluteal necrosis and to clarify the relationship between TAE and gluteal necrosis in pelvic fracture cases.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Comparison of rSO2 between the two groups (the groups where TAE is performed and not performed)

Key secondary outcomes

Incidence of gluteal necrosis and comparison of rSO2 before and after TAE in gluteal necrosis cases

Study type

Interventional

Basic design

Parallel

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

No treatment

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

The rSO2 of the bilateral gluteal muscles of subjects should be measured with INVOS 5100C (Medtronic). The measurement sites (where the sensors are applied) are the midline regions of both sides at the level of the greater trochanter. To prevent pressure ulcer, the sensor should be applied only at the time of measurement. The group of TAE should undergo measurement of rSO2 of the bilateral gluteal muscles before and after TAE. The rSO2 of the bilateral gluteal muscles should be measured on Days 1, 3, 7, and 14.

Interventions/Control_2

The group of non-TAE should undergo measurement of rSO2 of the bilateral gluteal muscles at initial arrival and on Days 3, 7, and 14.

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

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Adult patients weighing >=40 kg
Those with unstable/severe unstable pelvic fractures (based on the 2008 classification of pelvic injury provided by the Japanese Association for the Surgery of Trauma)

Key exclusion criteria

Patients for whom NIRS sensor cannot be applied (because of the presence of cutaneous lesion on the gluteal region, etc.)
Those for whom NIRS sensor cannot be applied on the gluteal midline regions due to open pelvic fracture
Those with stable pelvic fracture

Target sample size

300

Name of lead principal investigator

1st name
Middle name
Last name	Takaaki Maruhashi

Organization

Kitasato University School of Medicine

Division name

Department of Emergency and Critical Care Medicine

Zip code

Address

1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa

TEL

042-778-8111

Email

tmaruhasi@hotmail.co.jp

Name of contact person

1st name
Middle name
Last name	Takaaki Maruhashi

Organization

Kitasato University School of Medicine

Division name

Department of Emergency and Critical Care Medicine

Zip code

Address

1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa

TEL

042-778-8111

Homepage URL

Email

tmaruhasi@hotmail.co.jp

Institute

Kitasato University

Institute

Department

Personal name

Organization

The General Insurance Association of Japan

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

12

Month

15

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

Preinitiation

Date of protocol fixation

2018

Year

12

Month

15

Day

Date of IRB

Anticipated trial start date

2019

Year

02

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2018

Year

12

Month

10

Day

Last modified on

2018

Year

12

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040128