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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021680
Receipt No. R000025007
Scientific Title The evaluation of coagulation ability at leaving crdio-pulmonary bypass in cardiovascular surgery
Date of disclosure of the study information 2016/04/25
Last modified on 2017/02/13

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Basic information
Public title The evaluation of coagulation ability at leaving crdio-pulmonary bypass in cardiovascular surgery
Acronym The evaluation of coagulation ability at leaving crdio-pulmonary bypass in cardiovascular surgery
Scientific Title The evaluation of coagulation ability at leaving crdio-pulmonary bypass in cardiovascular surgery
Scientific Title:Acronym The evaluation of coagulation ability at leaving crdio-pulmonary bypass in cardiovascular surgery
Region
Japan

Condition
Condition Acute aortic disection
Thoracic aortic aneurysm
re-cardio-vascular surgery
Classification by specialty
Anesthesiology Cardiovascular surgery Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The evaluation of coagulation ability at leaving cardio-pulmonary bypass
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes result of thromboelastography after leaving cardio pulmonary bypass and administrating protamine
Key secondary outcomes relationship with other blood examination
total of bleeding
amount of postoperative transfusion

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
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
Medicine
Interventions/Control_1 befor leaving cardio-pulmonary bypass, FFP4Unit is administrated.
after leaving cardio-pulmonary bypass, FFP4Unit is administrated.
Interventions/Control_2 befor leaving cardio-pulmonary bypass, FFP isn't administrated.
after leaving cardio-pulmonary bypass, FFP8Unit is administrated.
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 Cardiovascular surgery cases with using FFP and/or PC : Acute aortic disection, Thorasic aortic aneurysm, Re-cardiovascular surgery
Key exclusion criteria incompatibility using FFP, PC, heaprin, protamine
When FFP and PC deviate from the prescribed time.
The patient is judged that joining to this study is inappropriate
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takahiro Tamura
Organization Japanease red cross nagoya daiichi hospital
Division name Anesthesiology
Zip code
Address 35, Michisita-cho 3, Nakamura-ku, Nagoya city, Aichi, Japan
TEL 0524815111
Email takahiro@nagoya-1st.jrc.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takahiro Tamura
Organization Japanease red cross nagoya daiichi hospital
Division name Anesthesiology
Zip code
Address 35, Michisita-cho 3, Nakamura-ku, Nagoya city, Aichi, Japan
TEL 0524815111
Homepage URL
Email takahiro@nagoya-1st.jrc.or.jp

Sponsor
Institute Nagoya university graduste school of medicine
Institute
Department

Funding Source
Organization Japanease red cross nagoya daiichi hospital
Organization
Division
Category of Funding Organization Other
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
2016 Year 04 Month 25 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
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
2016 Year 04 Month 25 Day
Date of IRB
Anticipated trial start date
2016 Year 04 Month 25 Day
Last follow-up date
2017 Year 02 Month 13 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 03 Month 30 Day
Last modified on
2017 Year 02 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025007

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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