UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A clinical multicenter study on efficacy and safety of C1-inhibitor concentrate for clinical amniotic fluid embolism
Title of the study (Brief title)	A clinical multicenter study on efficacy and safety of C1-inhibitor concentrate for clinical amniotic fluid embolism
Region	Japan

Condition
Condition	Clinical amniotic fluid embolism
Classification by specialty	Obsterics and gynecology Blood transfusion
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify the efficacy and safety of C1-inhibitor concentrate for clinical amniotic fluid embolism.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Improvement of clinical symptom and laboratory data
Key secondary outcomes	Presence or absence of side effects

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	16 years-old <=
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	Patients with amniotic fluid embolism who fill the criteria as follows, 1) Symptoms should occur within 12 hours after delivery. 2) Massive postpartum hemorrhage with unknown etiology that occurred within 2 hours after delivery. 3) Disseminated intravascular coagulation (DIC).
Key exclusion criteria	Patients with anaphylactic reaction to C1-inhibitor concentrate.
Target sample size	30

Research contact person
Name of lead principal investigator	Naohiro Kanayama
Organization	Hamamatsu University School of Medicine
Division name	Obstetrics and Gynecology
Address	1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka, Japan
TEL	053-435-2309
Email	kanayama@hama-med.ac.jp

Public contact
Name of contact person	Naoaki Tamura
Organization	Hamamatsu University School of Medicine
Division name	Obstetrics and Gynecology
Address	1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka, Japan
TEL	053-435-2309
Homepage URL
Email	ntamura@hama-med.ac.jp

Sponsor
Institute	Obstetrics and Gynecology, Hamamatsu University School of Medicine.
Institute
Department

Funding Source
Organization	None
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	2014 Year 11 Month 13 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 08 Month 30 Day
Anticipated trial start date	2014 Year 11 Month 14 Day
Last follow-up date	2020 Year 02 Month 28 Day
Date of closure to data entry	2020 Year 02 Month 28 Day
Date trial data considered complete	2020 Year 02 Month 28 Day
Date analysis concluded	2020 Year 02 Month 28 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	This study was completed by 2/28/2019.

Management information
Registered date	2014 Year 11 Month 13 Day
Last modified on	2019 Year 02 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018234