UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018998 |
|---|---|
| Receipt number | R000021974 |
| Scientific Title | Evaluation of perioperative changes of blood coagulation factors in patients with left ventricular assist device implantation and impact of XIII factors in postoperative hemostasis after LVAD implantation |
| Date of disclosure of the study information | 2015/10/01 |
| Last modified on | 2020/08/17 15:21:28 |
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Basic information
Public title
Evaluation of perioperative changes of blood coagulation factors in patients with left ventricular assist device implantation and impact of XIII factors in postoperative hemostasis after LVAD implantation
Acronym
Evaluation of perioperative changes of blood coagulation factors in patients with left ventricular assist device implantation and impact of XIII factors in postoperative hemostasis after LVAD implantation
Scientific Title
Evaluation of perioperative changes of blood coagulation factors in patients with left ventricular assist device implantation and impact of XIII factors in postoperative hemostasis after LVAD implantation
Scientific Title:Acronym
Evaluation of perioperative changes of blood coagulation factors in patients with left ventricular assist device implantation and impact of XIII factors in postoperative hemostasis after LVAD implantation
Region
| Japan |
Condition
Condition
patients with end-stage heart failure who underwent left ventricular assist device support
Classification by specialty
| Cardiovascular surgery | Blood transfusion |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the changes of blood coagulation factors in postoperative periods and the efficacy of concentrates of XIII factor in prevention of postoperative bleeding event
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
bleeding complication in postoperative periods including brain hemorrage, gastrointestinal hemorrage and wound bleeding requring blood transfusion
Key secondary outcomes
blood transfusion volume in postoperative period
amount of bleeding in postoperative period
perioperative changes of blood coagulation factors
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
control group:LVAD implantation
Interventions/Control_2
treatment group: LVAD implantation with postoperative administraion of concentrates of blood coagulation factor XIII (Fibrogammin® P 240U/V 5V) at the time of admission of intensive care unit and 24 and 48 hours after operation
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
the patients with end-stage heart failure due to dilated cardiomyopathy, ischemic cardiomyopathy and other cardiomyopathy who is planned to undergo left ventricular assit device implantation
Key exclusion criteria
the patients with sensitivity to concentrate of blood coagulaton factor XIII
the patients with sensitivity to other blood products
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiki Sawa |
Organization
Graduate school of Medicine, Osaka University
Division name
Department of Cardiovascular Surgery
Zip code
Address
2-2 Yamadaoka, Suita City, Osaka
TEL
06-6879-3154
k-domae@surg1.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keitaro Domae |
Organization
Graduate school of Medicine, Osaka University
Division name
Department of Cardiovascular Surgery
Zip code
Address
2-2 Yamadaoka, Suita City, Osaka
TEL
06-6879-3154
Homepage URL
k-domae@surg1.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Crdiovascular Surgery, Graduate School of Medicine, Osaka University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
none
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
大阪大学附属病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 01 | 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
| 2015 | Year | 09 | Month | 11 | Day |
Date of IRB
| 2015 | Year | 10 | Month | 15 | Day |
Anticipated trial start date
| 2015 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2020 | 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
| 2015 | Year | 09 | Month | 13 | Day |
Last modified on
| 2020 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021974
