UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006033 |
|---|---|
| Receipt number | R000007143 |
| Scientific Title | Time-dependent changes in intraplatelet signaling pathways relevant to platelet function defect with cardiopulmonary bypass surgery |
| Date of disclosure of the study information | 2011/07/25 |
| Last modified on | 2019/01/29 09:04:37 |
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Basic information
Public title
Time-dependent changes in intraplatelet signaling pathways relevant to platelet function defect with cardiopulmonary bypass surgery
Acronym
Plateltets defects in cardiopulmonary bypass
Scientific Title
Time-dependent changes in intraplatelet signaling pathways relevant to platelet function defect with cardiopulmonary bypass surgery
Scientific Title:Acronym
Plateltets defects in cardiopulmonary bypass
Region
| Japan |
Condition
Condition
Patients undergoing cardiac surgery with CPB, patients undergoing off-pump coronary artery bypass graft surgery, and healthy volunteers.
Classification by specialty
| Operative medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relationship between time-dependent changes in intra-platelet signaling pathways and those in platelet function in patients undergoing cardiac surgery with cardiopulmonary bypass (CPB).
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intraplatelet Bax increases after cardiopulmonary bypass contributes to reduced perioperative platelet-surface GPIb expression and platelet dysfunction during the perioperative period.
Key secondary outcomes
Changes in intraplatelet Bax and related pathways are less pronounced during and after off-pump cardiac procedures than for cardiopulmonary bypass.
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Patients undergoing coronary artery bypass graft with cardiopulmonary bypass
Interventions/Control_2
Patients undergoing coronary artery bypass graft without 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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with or without cardiopulmonary bypass were American Society of Anesthesiologists Physical Status class 3 or 4, and were aged 20-80 years.
Key exclusion criteria
We excluded patients and volunteers with conditions known or suspected to independently increase platelet activity; specifically, those with venous thrombosis, sepsis, acute infection, pregnancy, acute coronary syndromes, heparin-induced thrombocytopenic purpura, transient ischemic attacks, severe hypertension (>160/95 mmHg), recent cardiopulmonary bypass, or multiple sclerosis, preoperative hepatic, renal dysfunction, or severe respiratory disease. We also excluded patients who had received platelet transufusion perioperatively, or patients who could not discontinue aspirin 1 week before surgery and other non-steroidal anti-inflammatory medication at least 48 h preoperatively.
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasufumi Nakajima |
Organization
Kyoto Prefectural University of Medicine
Division name
Anesthesiology
Zip code
Address
Kamigyo-ku, Kyoto
TEL
075-251-5633
nakajima@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasufumi Nakajima |
Organization
Kyoto Prefectural University of Medicine
Division name
Anesthesiology
Zip code
Address
Kawaramachi Hirokoji, Kajii-cho
TEL
0752515633
Homepage URL
nakajima@koto.kpu-m.ac.jp
Sponsor or person
Institute
Dept Anesthesiology, Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2011 | Year | 07 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2011 | Year | 07 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | Month | 25 | Day |
Last follow-up date
| 2015 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
| 2015 | Year | 11 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 07 | Month | 25 | Day |
Last modified on
| 2019 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007143
| Research Plan | |
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| 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 |
