UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035209
Receipt No. R000040128
Scientific Title Predicting the occurrence of gluteal necrosis with near-infrared spectroscopy in pelvic fracture cases: A multicenter study
Date of disclosure of the study information 2018/12/15
Last modified on 2018/12/10

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
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
Condition pelvic fracture
Classification by specialty
Radiology Emergency medicine
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
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

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute Kitasato University
Institute
Department

Funding Source
Organization The General Insurance Association of Japan
Organization
Division
Category of Funding Organization Non profit foundation
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
2018 Year 12 Month 15 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 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
Other related information

Management information
Registered date
2018 Year 12 Month 10 Day
Last modified on
2018 Year 12 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040128

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.