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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034950
Receipt No. R000039851
Scientific Title Changes of thromboxane B2 following to lung collapse during thoracotomy
Date of disclosure of the study information 2018/11/20
Last modified on 2019/03/25

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Basic information
Public title Changes of thromboxane B2 following to lung collapse during thoracotomy
Acronym Changes of thromboxane B2 following to lung collapse during thoracotomy
Scientific Title Changes of thromboxane B2 following to lung collapse during thoracotomy
Scientific Title:Acronym Changes of thromboxane B2 following to lung collapse during thoracotomy
Region
Japan

Condition
Condition Lung Cancer
Classification by specialty
Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Study of serum thromboxane A2 as a modulator for hypotension following to lung collapse during one lung ventilated thoracotomy
Basic objectives2 Others
Basic objectives -Others Compare with prostaglandin F1 alfa measured with the same samples in the last study (UMIN000028856)
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Serum thromboxane B2 concentration(Before lung collapse, 15 minutes after lung collapse, 60 minutes after lung collapse)
Key secondary outcomes Serum prostaglandin F1 alfa (Before lung collapse, 15 minutes after lung collapse, 60 minutes after lung collapse): measured in the study registered as UMIN000028856

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Remifentanil and Flurbiprofen axytil
Interventions/Control_2 Fentanyl
Interventions/Control_3 Remifentanil
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 Cases of elective lung resection of lung cancer under one lung ventilation anesthesia
Key exclusion criteria Renal dysfunction (Serum creatinine>1.3mg/dL), history of non-steroidal antiinflammatory agent allergy, history of asthma
Target sample size 75

Research contact person
Name of lead principal investigator
1st name Hiromi
Middle name
Last name Katoh
Organization Hyogo Cancer Center
Division name Department of Anesthesia
Zip code 673-0021
Address 13-70 Kitaoji Akashi Hyogo
TEL 078-929-1151
Email whoami@hp.pref.hyogo.jp

Public contact
Name of contact person
1st name Hiromi
Middle name
Last name Katoh
Organization Hyogo Cancer Center
Division name Department of Anesthesia
Zip code 6730021
Address 13-70 Kitaoji Akashi Hyogo
TEL 078-929-1151
Homepage URL
Email whoami@hp.pref.hyogo.jp

Sponsor
Institute Hyogo Cancer Center
Department of Anesthesia
Institute
Department

Funding Source
Organization Hyogo Cancer Center
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Hyogo Cancer Center
Address 13-70 KitaOji Akashi
Tel 0789291151
Email crc_nakachi@hyogo-cc.jp

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 兵庫県立がんセンター(兵庫県)

Other administrative information
Date of disclosure of the study information
2018 Year 11 Month 20 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 75
Results
During lung resection, thromboxane B2 and theomboxane B2/prostaglandin F1a ration elevates in time dependent manner. Pretreatment of flurbiprofen axetyl inhibited these protanoid elevation.
Results date posted
2019 Year 03 Month 25 Day
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
2018 Year 11 Month 02 Day
Date of IRB
2018 Year 11 Month 02 Day
Anticipated trial start date
2018 Year 11 Month 02 Day
Last follow-up date
2018 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
2018 Year 11 Month 26 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 11 Month 20 Day
Last modified on
2019 Year 03 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039851

Research Plan
Registered date File name
2019/03/25 FLU_TBB2研究実施計画書_V2.docx

Research case data specifications
Registered date File name
2019/03/25 TBX data 1-75 Data作成用.xlsx

Research case data
Registered date File name
2019/03/25 TBX data 1-75.xlsx


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