UMIN-CTR Clinical Trial

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
Email	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
Email	k-domae@surg1.med.osaka-u.ac.jp

Sponsor
Institute	Department of Crdiovascular Surgery, Graduate School of Medicine, Osaka University
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021974