UMIN-CTR Clinical Trial

Basic information
Public title	Clinical study on the monitoring of heparin concentration and patient prognosis in cardiac surgery under cardiopulmonary bypass
Acronym	Clinical study on the monitoring of heparin concentration and patient prognosis in cardiac surgery under cardiopulmonary bypass
Scientific Title	Clinical study on the monitoring of heparin concentration and patient prognosis in cardiac surgery under cardiopulmonary bypass
Scientific Title:Acronym	Clinical study on the monitoring of heparin concentration and patient prognosis in cardiac surgery under cardiopulmonary bypass
Region	Japan

Condition
Condition	cardiac surgery under cardiopulmonary bypass
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine safe anticoagulant therapy and clarify relationship between blood heparin concentration and anti-inflammatory effect
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Amount of blood loss
Key secondary outcomes	Amount of blood transfusion, heparin dosage, protamine dosage, time to extubation, length of ICU stay, blood coagulation and fibrinolysis function, anti-inflammatory effect, artificial lung inlet pressure and artificial lung outlet pressure

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are 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	Administration of heparin based on ACT during cardiopulmonary bypass
Interventions/Control_2	Administration of heparin administered by keeping the blood heparin concentration fixed during cardiopulmonary bypass
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 undergoing elective cardiac surgery with cardiopulmonary bypass
Key exclusion criteria	1. Under 20 years old 2. Emergency operation 3. Major vascular surgery (circulatory arrest, selective cerebral perfusion) 4. Infective endocarditis 5. Patients with coagulation fibrinolysis abnormality by preoperative examination 6. Patient using auxiliary circulation before surgery
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Middle name Last name Mikiko Tomino
Organization	Tokyo Medical University Hachioji Medical Center
Division name	Department of Anesthesiology
Zip code
Address	1163 Tatemachi, Hachioji-shi, Tokyo, Japan
TEL	042-665-5611
Email	mikikong30@gmail.com

Public contact
Name of contact person	1st name Middle name Last name Mikiko Tomino
Organization	Tokyo Medical University Hachioji Medical Center
Division name	Department of Anesthesiology
Zip code
Address	1163 Tatemachi, Hachioji-shi, Tokyo, Japan
TEL	042-665-5611
Homepage URL
Email	mikikong30@gmail.com

Sponsor
Institute	Department of Anesthesiology, Tokyo Medical University Hachioji Medical Center
Institute
Department

Funding Source
Organization	Tokyo Medical University
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	2018 Year 12 Month 04 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	Preinitiation
Date of protocol fixation	2017 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date	2018 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 12 Month 03 Day
Last modified on	2018 Year 12 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039107

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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