UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Fibrinolysis and bleeding tendency in the patients with severe trauma.
Title of the study (Brief title)	Fibrinolysis and bleeding tendency in the patients with severe trauma.
Region	Japan

Condition
Condition	severe trauma
Classification by specialty	Emergency medicine Blood transfusion
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To confirm the fibrinolysis by measurement of several molecular markers, and to investigate treatment for the coagulopathy in the patients with severe trauma
Basic objectives2	Others
Basic objectives -Others	Observation of pathophysiology
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	General laboratory test of coagulation and fibrinolysis. Molecular markers of coagulation and fibrinolysis.
Key secondary outcomes

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	12 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Abbreviated Injury Scale (AIS) (1985) > 3
Key exclusion criteria	cardiac arreat
Target sample size	50

Research contact person
Name of lead principal investigator	Mineji Hayakawa
Organization	Hokkaido University Hospital
Division name	Emergency and Critical Care Center
Address	N14W5 Kita-ku, Sapporo 060-8648 Japan
TEL	011-706-7377
Email	mineji@dream.com

Public contact
Name of contact person	Mineji Hayakawa
Organization	Hokkaido University Hospital
Division name	Emergency and Critical Care Center
Address	Sapporo
TEL	011-706-7377
Homepage URL
Email	mineji@dream.com

Sponsor
Institute	Emergency and Critical Care, Hokkaido University Hospital
Institute
Department

Funding Source
Organization	Emergency and Critical Care, Hokkaido University Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2010 Year 01 Month 28 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 04 Month 01 Day
Anticipated trial start date	2009 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2017 Year 02 Month 03 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	To confirm the fibrinolysis by measurement of several molecular markers, and to investigate treatment for the coagulopathy in the patients with severe trauma [Observational paramerter] General laboratory test of coagulation and fibrinolysis. Molecular markers of coagulation and fibrinolysis.

Management information
Registered date	2010 Year 01 Month 28 Day
Last modified on	2017 Year 02 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000003774