UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041201 |
|---|---|
| Receipt number | 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 07:35:23 |
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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
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
htakahashi-tmd@umin.ac.jp
Sponsor or person
Institute
Teine Keijinkai Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047048
