UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006832
Receipt No. R000008085
Scientific Title Evaluation of time course hemostatic changes by ROTEM in pateints undergoing pediatric cardiac surgery
Date of disclosure of the study information 2011/12/04
Last modified on 2015/04/08

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Evaluation of time course hemostatic changes by ROTEM in pateints undergoing pediatric cardiac surgery
Acronym ROTEM in pateints undergoing pediatric cardiac surgery
Scientific Title Evaluation of time course hemostatic changes by ROTEM in pateints undergoing pediatric cardiac surgery
Scientific Title:Acronym ROTEM in pateints undergoing pediatric cardiac surgery
Region
Japan

Condition
Condition pediatric patients undergoing cardiac surgery
Classification by specialty
Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate whether parameters obtained from pediatric patients undergoing cardiac surgery were related to patients outcome.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes perioperative blood loss, transfusion
Key secondary outcomes ICU stay

Base
Study type

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking YES
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 ROTEM group
Interventions/Control_2 Conventinal 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

Not applicable
Age-upper limit
20 years-old >
Gender Male and Female
Key inclusion criteria pediatric patients undergoing cardiac surgery
Key exclusion criteria pediatric patients undergoing emergent cardiac surgery
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasufumi Nakajima
Organization Kyoto Prefectural University of Medicine
Division name Dept of Anesthesiology
Zip code
Address Kyoto, Japan
TEL 075-251-5633
Email nakajima@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasufumi Nakajima
Organization Kyoto Prefectural University of Medicine
Division name Dept of Anesthesiology
Zip code
Address Kawaramachi Hirokoji Kamigyo Kyoto
TEL 075-251-5633
Homepage URL
Email nakajima@koto.kpu-m.ac.jp

Sponsor
Institute Dept of Anesthesiology
Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization Dept of Anesthesiology
Kyoto Prefectural University of Medicine
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
Address
Tel
Email

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
2011 Year 12 Month 04 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
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
2011 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 12 Month 11 Day
Last follow-up date
2013 Year 06 Month 15 Day
Date of closure to data entry
2013 Year 06 Month 15 Day
Date trial data considered complete
Date analysis concluded
2013 Year 06 Month 30 Day

Other
Other related information under investigation

Management information
Registered date
2011 Year 12 Month 04 Day
Last modified on
2015 Year 04 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008085

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.