UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030763 |
|---|---|
| Receipt number | R000035128 |
| Scientific Title | Clinical factors affecting massive blood transfusion in ruptured aortic abdominal aneurysm surgery |
| Date of disclosure of the study information | 2018/01/12 |
| Last modified on | 2019/07/18 13:16:36 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Clinical factors affecting massive blood transfusion in ruptured aortic abdominal aneurysm surgery
Acronym
Clinical factors affecting massive blood transfusion in ruptured aortic abdominal aneurysm surgery
Scientific Title
Clinical factors affecting massive blood transfusion in ruptured aortic abdominal aneurysm surgery
Scientific Title:Acronym
Clinical factors affecting massive blood transfusion in ruptured aortic abdominal aneurysm surgery
Region
| Japan |
Condition
Condition
surgical patients with ruptured abdominal aortic aneurysm
Classification by specialty
| Vascular surgery | Anesthesiology | Cardiovascular surgery |
| Blood transfusion |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the study is to determine clinical factors for the prediction of total volume of transfusion.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Total volume of blood transfusion during surgery
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Surgical patient for repair of ruptured abdominal aortic aneurysm
Key exclusion criteria
None
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Shigekazu |
| Middle name | |
| Last name | Sugino |
Organization
Tohoku University
Division name
Department of Anesthesiology and Perioperative Medicine
Zip code
9800875
Address
2-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8575, Japan
TEL
0227177321
sugino@ruby.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Shigekazu |
| Middle name | |
| Last name | Sugino |
Organization
Tohoku University
Division name
Department of Anesthesiology and Perioperative Medicine
Zip code
9800875
Address
2-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8575, Japan
TEL
0227177321
Homepage URL
sugino@ruby.ocn.ne.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Tohoku University School of Medicine IRB
Address
2-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8575, Japan
Tel
0227284105
med-kenkyo@grp.tohoku.ac.jp
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
| 2018 | Year | 01 | Month | 12 | 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
48
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
| 2018 | Year | 01 | Month | 11 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 22 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 24 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We assigned 48 patients to the trial. However, we stopped the study because there was not any difference in the population.
Management information
Registered date
| 2018 | Year | 01 | Month | 11 | Day |
Last modified on
| 2019 | Year | 07 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035128
