UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036132 |
|---|---|
| Receipt number | R000041163 |
| Scientific Title | A multi-institutional observational study on efficacy of extracorporeal membrane oxygenation in accidentally severe hypothermia |
| Date of disclosure of the study information | 2019/04/01 |
| Last modified on | 2022/09/10 09:47:21 |
* 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
A multi-institutional observational study on efficacy of extracorporeal membrane oxygenation in accidentally severe hypothermia
Acronym
Intensive Care with ECMO Rewarming in Accidentally Severe Hypothermia study
(ICE-CRASH study)
Scientific Title
A multi-institutional observational study on efficacy of extracorporeal membrane oxygenation in accidentally severe hypothermia
Scientific Title:Acronym
Intensive Care with ECMO Rewarming in Accidentally Severe Hypothermia study
(ICE-CRASH study)
Region
| Japan |
Condition
Condition
Accidental hypothermia
Classification by specialty
| Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the efficacy and prognosis of ECMO rewarming in accidentally severe hypothermia.
Basic objectives2
Others
Basic objectives -Others
To compare the prognosis of ECMO group and non-ECMO group
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
28-day mortality and in-hospital mortality rate
Key secondary outcomes
Duration of ICU stay
Rates of complications
Factors related to indication of ECMO
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 presenting to the emergency department with accidentally severe hypothermia (core temperature <32 degrees C)
Key exclusion criteria
Patients whose body temperature was unknown.
Patients age <18.
Do-not-resuscitation status.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mineji Hayakawa |
Organization
Hokkaido University Hospital
Division name
Emergency and Critical Care Center
Zip code
Address
N14W5, Kita-ku, Sapporo, 060-8648, Japan
TEL
011-706-7377
mineji@dream.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shuhei Takauji |
Organization
Asahikawa Medical University
Division name
Department of Emergency Medicine
Zip code
Address
2-1, Midorigaoka Higashi, Asahikawa, 078-8510, Japan
TEL
0166-68-2852
Homepage URL
s-takauji@asahiakwa-med.ac.jp
Sponsor or person
Institute
Japanese Association for Acute Medicine
Institute
Department
Personal name
Funding Source
Organization
Japanese Association for Acute Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2019 | 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
Completed
Date of protocol fixation
| 2019 | Year | 01 | Month | 07 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 04 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The efficacy of ECMO rewarming in accidentally severe hypothermia
Management information
Registered date
| 2019 | Year | 03 | Month | 08 | Day |
Last modified on
| 2022 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041163
