UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022919 |
|---|---|
| Receipt number | R000026408 |
| Scientific Title | Association between intra-circuit activated clotting time and incidence of bleeding complications during continuous renal replacement therapy using nafamostat mesilate: a retrospective observational study |
| Date of disclosure of the study information | 2016/07/01 |
| Last modified on | 2016/06/27 22:30:39 |
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Basic information
Public title
Association between intra-circuit activated clotting time and incidence of bleeding complications during continuous renal replacement therapy using nafamostat mesilate: a retrospective observational study
Acronym
Association between intra-circuit activated clotting time and incidence of bleeding complications during continuous renal replacement therapy using nafamostat mesilate: a retrospective observational study
Scientific Title
Association between intra-circuit activated clotting time and incidence of bleeding complications during continuous renal replacement therapy using nafamostat mesilate: a retrospective observational study
Scientific Title:Acronym
Association between intra-circuit activated clotting time and incidence of bleeding complications during continuous renal replacement therapy using nafamostat mesilate: a retrospective observational study
Region
| Japan |
Condition
Condition
Critically ill patients who required continuous renal replacement therapy
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To observe the association between intra-circuit activated clotting time and incidence of bleeding complications during continuous renal replacement therapy with nafamostat mesilate.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the incidence of bleeding complications
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
Adult critically ill patients who required continuous renal replacement therapy in our intensive care unit from January 2011 to December 2013.
Key exclusion criteria
Patients who required additional extracorporeal intervention including extracorporeal membrane oxygenation or intra-aortic balloon pumping.
Patients who were administered other anticoagulants including unfractionated heparin and gabexate mesilate.
Target sample size
122
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Moritoki Egi |
Organization
Kobe University Hospital
Division name
Anesthesiology
Zip code
Address
7-5-2, Chuo-ku, Kobe, Hyogo
TEL
0783826172
moriori@tg8.so-net.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shohei Makino |
Organization
Kobe University Hospital
Division name
Anesthesiology
Zip code
Address
7-5-2, Chuo-ku, Kobe, Hyogo
TEL
0783826172
Homepage URL
timasuke555@yahoo.co.jp
Sponsor or person
Institute
Kobe University Hospital
Institute
Department
Personal name
Funding Source
Organization
nil
Organization
Division
Category of Funding Organization
Self funding
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
| 2016 | Year | 07 | 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
Completed
Date of protocol fixation
| 2014 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
patients demographics
the incidence of bleeding complications
filter life
Management information
Registered date
| 2016 | Year | 06 | Month | 27 | Day |
Last modified on
| 2016 | Year | 06 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026408
