UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035112 |
|---|---|
| Receipt number | R000039107 |
| Scientific Title | 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 | 2023/06/19 14:13:53 |
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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 | Mikiko |
| Middle name | |
| Last name | Tomino |
Organization
Tokyo Medical University Hachioji Medical Center
Division name
Department of Anesthesiology
Zip code
1930998
Address
1163 Tatemachi, Hachioji-shi, Tokyo, Japan
TEL
042-665-5611
mikikong30@gmail.com
Public contact
Name of contact person
| 1st name | Mikiko |
| Middle name | |
| Last name | Tomino |
Organization
Tokyo Medical University Hachioji Medical Center
Division name
Department of Anesthesiology
Zip code
1930998
Address
1163 Tatemachi, Hachioji-shi, Tokyo, Japan
TEL
042-665-5611
Homepage URL
mikikong30@gmail.com
Sponsor or person
Institute
Department of Anesthesiology, Tokyo Medical University Hachioji Medical Center
Institute
Department
Personal name
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
research and development center of Tokyo Medical University
Address
6-7-1,nishishinjuku,shinjuku-ku,Tokyo,Japan
Tel
0333426111
IRB@tokyo-med.ac.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
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
Terminated
Date of protocol fixation
| 2017 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
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
| 2023 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039107
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
