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

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 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

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

Value
https://center6.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