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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024163
Receipt No. R000027672
Scientific Title Coagulation effect of sugammadex using thromboelastography in a randomized controlled study of surgical patients
Date of disclosure of the study information 2016/09/26
Last modified on 2018/02/21

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Basic information
Public title Coagulation effect of sugammadex using
thromboelastography in a randomized controlled study of surgical patients
Acronym Coagulation effect of sugammadex using
thromboelastography
Scientific Title Coagulation effect of sugammadex using
thromboelastography in a randomized controlled study of surgical patients
Scientific Title:Acronym Coagulation effect of sugammadex using
thromboelastography
Region
Asia(except Japan)

Condition
Condition Anticoagulant action of sugammadex
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the influence of
sugammadex, reversing agent of steroidal
neuromuscular blocking agent, on
coagulation competence as measured by
the thromboelastography in perioperative
period after abdominal surgery.
Basic objectives2 Pharmacodynamics
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes reaction time (r)
coagulation time (k)
Key secondary outcomes Maximum rate of thrombus generation (MRTG)
Time to maximum rate of
thrombus generation (TMRTG)
Maximum amplitude (MA)
Angle alpha

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Pyridostigmine 0.15 mg/kg plus glycopyrrolated administered atthe end of surgery.
Interventions/Control_2 Sugammadex 4mg/kg, administered at the end of surgery
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
19 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria American society of Anesthesiologists physical class 1-2, presenting for elective surgery (gynaecological, urologic, and colorectal surgery) were enrolled.
Key exclusion criteria Patients were excluded from study if they have neuromuscular disease, hereditary coagulation defect, renal or hepatic dysfunction, known allergy to sugammadex, recent history of hemorrhage or thrombosis within 30 days, difficult airway features, abnormal coagulation laboratory value
(e.g., prothrombin time internalization normalized ratio >1.5, activated partial thromboplastin time > 50 sec), or if they were pregnant or women who were breast feeding.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hae Wone Chang
Organization Korea University Guro Hospital
Division name Anesthesiology and Pain Medicine
Zip code
Address 148 Gurodong-ro, Guro-gu, Seoul
TEL 82226263237
Email chelenh@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Mido Lee
Organization Korea University Guro Hospital
Division name Anesthesiology and Pain Medicine
Zip code
Address 148 Gurodong-ro, Guro-gu, Seoul
TEL 82226261437
Homepage URL
Email midoyee@gmail.com

Sponsor
Institute Korea University Guro Hospital
Department of Anesthesiology and Pain
Medicine
Institute
Department

Funding Source
Organization Korea University Guro Hospital
Department of Anesthesiology and Pain
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 Korea University Guro Hospital (Seoul)

Other administrative information
Date of disclosure of the study information
2016 Year 09 Month 26 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 09 Month 22 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 27 Day
Last follow-up date
2017 Year 12 Month 17 Day
Date of closure to data entry
2018 Year 02 Month 21 Day
Date trial data considered complete
2018 Year 02 Month 21 Day
Date analysis concluded
2018 Year 02 Month 21 Day

Other
Other related information

Management information
Registered date
2016 Year 09 Month 26 Day
Last modified on
2018 Year 02 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027672

Research Plan
Registered date File name
2017/09/27 researchplan.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name
2018/02/21 data_bridionupdate.xlsx


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