UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018355 |
|---|---|
| Receipt number | R000021251 |
| Scientific Title | The study of coagulation change and transfusion management during living-donor kidney transplantation |
| Date of disclosure of the study information | 2015/07/21 |
| Last modified on | 2015/07/22 17:00:52 |
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Basic information
Public title
The study of coagulation change and transfusion management during living-donor kidney transplantation
Acronym
The study of coagulation change and transfusion management during living-donor kidney transplantation
Scientific Title
The study of coagulation change and transfusion management during living-donor kidney transplantation
Scientific Title:Acronym
The study of coagulation change and transfusion management during living-donor kidney transplantation
Region
| Japan |
Condition
Condition
end-stage renal failure
Classification by specialty
| Surgery in general | Anesthesiology | Operative medicine |
| Blood transfusion |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study investigated perioperative transfusion management using rotational thromboelastometry (ROTEM) in patients undergoing ABO-incompatible LKT.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amounts of perioperative fluid, including blood cells (MAP), fresh frozen product (FFP), 5% albumin, crystalloid and urine, and data of ROTEM were also compared.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patients who underwent LKT at our University Hospital from January 2013 to March 2015.
Key exclusion criteria
Patients with blood disease were excluded.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Shirozu |
Organization
Kyushu university hospital
Division name
Operating room
Zip code
Address
Maedashi 3-1-1, Fukuoka JAPAN
TEL
81-92-642-5714
shiron@kuaccm.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Shirozu |
Organization
Kyushu university hospital
Division name
Operating room
Zip code
Address
Maedashi 3-1-1, Fukuoka JAPAN
TEL
81-92-642-5714
Homepage URL
shiron@kuaccm.med.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Anesthesiology and Critical Care Medicine, Kyushu University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
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
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
| 2015 | Year | 07 | Month | 21 | 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 | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 13 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The patients who underwent LKT were divided into two groups; received preoperative PEX therapy (PEX group) and did not (non-PEX group).
Management information
Registered date
| 2015 | Year | 07 | Month | 20 | Day |
Last modified on
| 2015 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021251
