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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035112
Receipt No. R000039107
Official scientific title of the study Clinical study on the monitoring of heparin concentration and patient prognosis in cardiac surgery under cardiopulmonary bypass
Date of disclosure of the study information 2018/12/04
Last modified on 2018/12/03

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Basic information
Official scientific title of the study Clinical study on the monitoring of heparin concentration and patient prognosis in cardiac surgery under cardiopulmonary bypass
Title of the study (Brief title) 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 Mikiko Tomino
Organization Tokyo Medical University Hachioji Medical Center
Division name Department of Anesthesiology
Address 1163 Tatemachi, Hachioji-shi, Tokyo, Japan
TEL 042-665-5611
Email mikikong30@gmail.com

Public contact
Name of contact person Mikiko Tomino
Organization Tokyo Medical University Hachioji Medical Center
Division name Department of Anesthesiology
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)

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

Progress
Recruitment status Preinitiation
Date of protocol fixation
2017 Year 10 Month 01 Day
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

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Publication of results Unpublished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