UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of prothrombin complex concentrate in intracranial hemorrhage patients under anticoagulant therapy
Title of the study (Brief title)	Prothrombin complex concentratein intracranial hemorrhage patients
Region	Japan

Condition
Condition	Intracranial hemorrhage
Classification by specialty	Neurology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the efficacy of prothrombin complex concentrate in intracranial hemorrhage patients under anticoagulant therapy
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	PT-INR value at 30 minutes after infusion of prothrombin complex concentrate
Key secondary outcomes	expansion of hematoma

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Intravenous administration of Prothrombin complex concentrate (500-1000 unit) and Vitamin K 10mg A dose of PCC PT-INR 2.0-2.9; 500 unit PT-INR 3.0>; 1000 unit
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	Intracranial hemorrhage within 24 hours after onset and INR value more than 2.0 under warfarin therapy
Key exclusion criteria	Patients with contraindication for complex concentrate and Vitamin K Patients with fatal intracranial hemorrhage Inappropriate patients for this study judged by the physicians.
Target sample size	15

Research contact person
Name of lead principal investigator	Toshiki Mizuno
Organization	Kyoto Prefectural University of Medicine
Division name	Neurology
Address	465 Kajii-cho, Kamigyo-ku, Kyoto
TEL	075-251-5793
Email	mizuno@koto.kpu-m.ac.jp

Public contact
Name of contact person	Tomoyuki Ohara
Organization	Kyoto Prefectural University of Medicine
Division name	Neurology
Address	465 Kajii-cho, Kamigyo-ku, Kyoto
TEL	075-251-5793
Homepage URL
Email	ohatomo@koto.kpu-m.ac.jp

Sponsor
Institute	Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization	Kyoto Prefectural University of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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 02 Month 17 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 04 Month 30 Day
Anticipated trial start date	2016 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 02 Month 17 Day
Last modified on	2018 Year 02 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023486