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Recruitment status Completed
Unique ID issued by UMIN UMIN000012176
Receipt No. R000014234
Official scientific title of the study Evaluation of the Efficacy and Safety of Short Time Bed Rest to Stop Bleeding with Exoseal Study
Date of disclosure of the study information 2013/10/30
Last modified on 2015/04/13

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Basic information
Official scientific title of the study Evaluation of the Efficacy and Safety of Short Time Bed Rest to Stop Bleeding with Exoseal Study
Title of the study (Brief title) E-stone Study
Region
Japan

Condition
Condition Peripheral artery disease, Coronary artery disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy of short time bed rest after using Exoseal
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Pain score (efficacy outcome)
Major adverse event within 30 days (safety outcome)
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Bed rest time is 2.5 hours after using Exoseal.
Interventions/Control_2 Bed rest time is 4.0 hours after using Exoseal.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patiens for whom Exoseal is used to get hemostasis.
Key exclusion criteria Patients who did not agree with this study
Target sample size 400

Research contact person
Name of lead principal investigator Takayuki Ishihara
Organization Kansai Rosai Hospital
Division name Cardiovascular Center
Address Inabaso 3-1-69, Amagasaki, Hyogo, Japan
TEL 06-6416-1221
Email t.ishihara31@gmail.com

Public contact
Name of contact person Takayuki Ishihara
Organization Kansai Rosai Hospital
Division name Cardiovascular Center
Address Inabaso 3-1-69, Amagasaki, Hyogo, Japan
TEL 06-6416-1221
Homepage URL
Email t.ishihara31@gmail.com

Sponsor
Institute Kansai Rosai Hospital Cardiovascular Center
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization None
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
2013 Year 10 Month 30 Day

Progress
Recruitment status Completed
Date of protocol fixation
2013 Year 10 Month 21 Day
Anticipated trial start date
2013 Year 10 Month 30 Day
Last follow-up date
2014 Year 11 Month 21 Day
Date of closure to data entry
2015 Year 01 Month 31 Day
Date trial data considered complete
2015 Year 01 Month 31 Day
Date analysis concluded
2015 Year 01 Month 31 Day

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

Management information
Registered date
2013 Year 10 Month 30 Day
Last modified on
2015 Year 04 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014234


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