UMIN-CTR Clinical Trial

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
Email	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
Email	sugino@ruby.ocn.ne.jp

Sponsor
Institute	Tohoku University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035128