UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	the evaluation of blood coagulation and platelet function during operation for the patients whom proposed to massive hemorrhage
Title of the study (Brief title)	the evaluation of blood coagulation and platelet function during operation for the patients whom proposed to massive hemorrhage
Region	Japan

Condition
Condition	Patients whom proposed massive hemorrhage during operation
Classification by specialty	Surgery in general Vascular surgery Chest surgery Cardiovascular surgery Emergency medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	we study the usefulness of blood coagulation and platelet function analyzer at the massive hemorrhage
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	total amount of fluid and transfusion during operation
Key secondary outcomes	total amount of hemorrhage during operation, the amount of transfusion and hemorrhage 24hr after operation, the correlation between the value of blood sample and that of blood coagulation and platelet function analyzer

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Sonoclot group
Interventions/Control_2	Control group
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	20 years-old <=
Age-upper limit	90 years-old >
Gender	Male and Female
Key inclusion criteria	Patients aged 20 to 90 with ASA-physical status 1 to 4 whom proposed massive hemorrhage during operation
Key exclusion criteria	Patients whom were unconscious and refused the participation of the study
Target sample size	100

Research contact person
Name of lead principal investigator	Mitsutaka Edanaga
Organization	Sapporo Medical University School of Medicine
Division name	Department of Anesthesiology
Address	S1, W16, Chuo-ku, Sapporo, Hokkaido, Japan
TEL	011-611-2111
Email	edanaka@sapmed.ac.jp

Public contact
Name of contact person	Hiroshi Takeda
Organization	Sapporo Medical University School of Medicine
Division name	Hospital Division
Address	S1, W16, Chuo-ku, Sapporo, Hokkaido, Japan
TEL	011-611-2111
Homepage URL
Email	hiroshi.takeda@sapmed.ac.jp

Sponsor
Institute	Sapporo Medical University School of Medicine
Institute
Department

Funding Source
Organization	Department of Anesthesiology, Sapporo Medical University School of Medicine
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	2015 Year 04 Month 28 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 02 Month 17 Day
Anticipated trial start date	2014 Year 03 Month 19 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 04 Month 27 Day
Last modified on	2018 Year 06 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020066