UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prediction of in-circuit coagulation using blood coagulation analyzer in continuous renal replacement therapy
Title of the study (Brief title)	Prediction of in-circuit coagulation using blood coagulation analyzer in CRRT
Region	Japan

Condition
Condition	critically ill patient
Classification by specialty	Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We will retrospectively investigate whether the blood coagulation analyzer "ROTEM" which can measure blood coagulation and fibrinolysis easily and quickly is a device capable of predicting in-circuit coagulation at CRRT.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Relationship between ROTEM parameter and in-circuit coagulation
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients in which ROTEM was measured at our hospital ICU and CRRT was performed
Key exclusion criteria	none
Target sample size	60

Research contact person
Name of lead principal investigator	Hiroomi Tatsumi
Organization	Sapporo Medical University School of Medicine
Division name	Department of Intensive Care Medicine
Address	South 1 West 16, Chuo-ku, Sapporo, Japan
TEL	011-611-2111
Email	htatsumi@sapmed.ac.jp

Public contact
Name of contact person	Hiroomi Tatsumi
Organization	Sapporo Medical University School of Medicine
Division name	Department of Intensive Care Medicine
Address	South 1 West 16, Chuo-ku, Sapporo, Japan
TEL	011-611-2111
Homepage URL	http://sapmedicu.com/research.html
Email	htatsumi@sapmed.ac.jp

Sponsor
Institute	Department of Intensive Care Medicine, Sapporo Medical University School of Medicine
Institute
Department

Funding Source
Organization	Department of Intensive Care Medicine, Sapporo Medical University School of Medicine
Organization
Division
Category of Funding Organization	Other
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	2018 Year 04 Month 13 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2018 Year 01 Month 11 Day
Anticipated trial start date	2018 Year 01 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol	http://sapmedicu.com/research.html
Publication of results	Unpublished
URL releasing results
Results	Of the ROTEM parameters, INTEM-CT, EXTEM-alfa angle, EXTEM-MCF were shown to be effective for predicting in-circuit coagulation.
Other related information	We compared general blood test values (ACT, platelet count, fibrinogen, FDP) and ROTEM parameters.

Management information
Registered date	2018 Year 04 Month 12 Day
Last modified on	2018 Year 04 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036746