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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028579
Receipt No. R000032708
Scientific Title Efficacy of FloSeal in brain tumor resection
Date of disclosure of the study information 2017/08/08
Last modified on 2018/10/16

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Basic information
Public title Efficacy of FloSeal in brain tumor resection
Acronym Efficacy of FloSeal in brain tumor resection
Scientific Title Efficacy of FloSeal in brain tumor resection
Scientific Title:Acronym Efficacy of FloSeal in brain tumor resection
Region
Japan

Condition
Condition Brain tumor
Classification by specialty
Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The efficacy of FloSeal in brain tumor resection will be evaluated.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Efficacy of FloSeal to stop bleeding
The bleeding would be classified in 4 grades. (1.Mild 2. Moderate 3. Sever 4. Life-threatening)
Succeed of hemostasis or not would be evaluated after applying FloSeal.
Key secondary outcomes Events occurred during patients' hospitalization for the first one week after the surgery.

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 After tumor removal, we would apply FloSeal at the point of bleeding which was difficult to stop with other methods.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients will undergo the tumor resection surgery, who is thought to be used FloSeal.
Key exclusion criteria Who has allergy to bovine protein.
Who has infection at the surgical field.
The tumor is in the eye ball
Who has coagulopathy
Pregnant patient
Who is diagnosed with Hypofibrinogenaemia
Who the surgeons thought that it is not appropriate to use FloSeal.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahiro Toda
Organization Keio University School of Medicine
Division name Department of Neurosurgery
Zip code
Address 35 Shinano-machi Shinjuku-ku Tokyo
TEL 03-5363-3808
Email todam@keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masahiro Toda
Organization Keio University School of Medicine
Division name Department of Neurosurgery
Zip code
Address 35 Shinano-machi Shinjuku-ku Tokyo
TEL 03-5363-3808
Homepage URL
Email todam@keio.jp

Sponsor
Institute Keio University School of Medicine
Department of Neurosurgery
Institute
Department

Funding Source
Organization Baxter
Organization
Division
Category of Funding Organization Profit organization
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
2017 Year 08 Month 08 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
2017 Year 08 Month 08 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 10 Day
Last follow-up date
2018 Year 08 Month 21 Day
Date of closure to data entry
2018 Year 09 Month 16 Day
Date trial data considered complete
2018 Year 10 Month 16 Day
Date analysis concluded
2018 Year 10 Month 16 Day

Other
Other related information

Management information
Registered date
2017 Year 08 Month 08 Day
Last modified on
2018 Year 10 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032708

Research Plan
Registered date File name
2017/08/14 FLOSEAL study Protocol 1706.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name


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