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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000041201
Receipt No. R000047048
Scientific Title Coagulopathy in transferred patients with massive hemorrhage
Date of disclosure of the study information 2020/08/01
Last modified on 2020/07/24

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Basic information
Public title Coagulopathy in transferred patients with massive hemorrhage
Acronym Coagulopathy in transferred patients with massive hemorrhage
Scientific Title Coagulopathy in transferred patients with massive hemorrhage
Scientific Title:Acronym Coagulopathy in transferred patients with massive hemorrhage
Region
Japan

Condition
Condition massive hemorrhage
Classification by specialty
Emergency medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess medical procedures, particularly DCR, at the time of transfer between hospitals for the purpose of treating massive hemorrhage in our medical administration area
Basic objectives2 Others
Basic objectives -Others The purpose of this study is to discuss the current status of transfer and medical treatment until the arrival of our hospital and to improve the prognosis of patients with massive hemorrhage in the community.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes 30-day mortality
Key secondary outcomes coagulopathy at our center (coagulopathy was defined as fibrinogen value <= 150 mg/dl, or PT-INR >= 1.5)
volume of blood products transfused

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
90 years-old >=
Gender Male and Female
Key inclusion criteria Massive hemorrhage was defined as follows:
1) systolic blood pressure <= 90 mmHg at the referring hospital
2) shock index (heart rate / systolic blood pressure) >= 1 at the referring hospital
3) in cases of maternal hemorrhage, cumulative blood loss >=1,000 ml or blood loss accompanied by signs or symptoms of hypovolemia
4) the judgement of the doctor from the referring hospital
Key exclusion criteria patients who experienced cardiac arrest before arrival at our center
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Satoshi
Middle name
Last name Nara
Organization Teine Keijinkai Hospital
Division name Emergency and Critical Care Medical Center
Zip code 006-8555
Address 1-jo 12-chome, Maeda, Teine-ku, Sapporo
TEL 011-681-8111
Email naras.tdr@keijinkai.or.jp

Public contact
Name of contact person
1st name Hiroyuki
Middle name
Last name Takahashi
Organization Teine Keijinkai Hospital
Division name Emergency and Critical Care Medical Center
Zip code 006-8555
Address 1-jo 12-chome, Maeda, Teine-ku, Sapporo
TEL 011-681-8111
Homepage URL
Email htakahashi-tmd@umin.ac.jp

Sponsor
Institute Teine Keijinkai Hospital
Institute
Department

Funding Source
Organization none
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 Teine Keijinkai Hospital
Address 1-jo 12-chome, Maeda, Teine-ku, Sapporo
Tel 011-681-8111
Email htakahashi-tmd@umin.ac.jp

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
2020 Year 08 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 132
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
2020 Year 02 Month 13 Day
Date of IRB
2020 Year 02 Month 27 Day
Anticipated trial start date
2020 Year 03 Month 01 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2020 Year 07 Month 24 Day
Last modified on
2020 Year 07 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047048

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2020/07/24 dateset.xlsx


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