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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | cardiac surgery under cardiopulmonary bypass | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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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 |
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 | |
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 |
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Progress | |||||||
Recruitment status | Preinitiation | ||||||
Date of protocol fixation |
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Anticipated trial start date |
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Last follow-up date | |||||||
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Date analysis concluded |
Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
URL releasing results | |
Results | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |