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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000042842
Receipt No. R000048863
Scientific Title The effect of cryoprecipitate and fibrinogen concentrate for treating postpartum hemorrhage: a descriptive study
Date of disclosure of the study information 2020/12/28
Last modified on 2020/12/24

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Basic information
Public title The effect of cryoprecipitate and fibrinogen concentrate for treating postpartum hemorrhage: a descriptive study
Acronym Descriptive comparison of cryoprecipitate and fibrinogen concentrate for treating PPH
Scientific Title The effect of cryoprecipitate and fibrinogen concentrate for treating postpartum hemorrhage: a descriptive study
Scientific Title:Acronym Descriptive comparison of cryoprecipitate and fibrinogen concentrate for treating PPH
Region
Japan

Condition
Condition postpartum hemorrhage
Classification by specialty
Obsterics and gynecology Anesthesiology Blood transfusion
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate how cryoprecipitate and fibrinogen concentrate are being used for postpartum hemorrhage retrospectively, and reveal the effectiveness and disadvantage.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Volume of transfusion after cryoprecipitate or fibrinogen concentrate
Key secondary outcomes Total bleeding volume, transfusion of RBC, FFP, or platelet, coagulation parameters

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
18 years-old <=
Age-upper limit
45 years-old >=
Gender Female
Key inclusion criteria Women who delivered at Juntendo University Hospital from April 2015 to August 2020, and had all the criteria below: had postpartum hemorrhage, severe hemorrhage over 2,000 mL or acquired hypofibrinogenemia less then 200 mg / dL, and treated with cryoprecipitate or fibrinogen concentrate.
Key exclusion criteria Exclusion criteria were women with congenital hypofibrinogenemia, artificial abortion, or miscarriage.
Target sample size 34

Research contact person
Name of lead principal investigator
1st name Hisako
Middle name
Last name Okada
Organization Juntendo University Faculty of Medicine
Division name Department of Anesthesiology and Pain Medicine
Zip code 113-8431
Address 3-1-3, Hongo, Bunkyo-ku, Tokyo
TEL 03-3813-3111
Email h-okada@juntendo.ac.jp

Public contact
Name of contact person
1st name Hisako
Middle name
Last name Okada
Organization Juntendo University Faculty of Medicine
Division name Department of Anesthesiology and Pain Medicine
Zip code 113-8431
Address 3-1-3, Hongo, Bunkyo-ku, Tokyo
TEL 03-3813-3111
Homepage URL
Email h-okada@juntendo.ac.jp

Sponsor
Institute Juntendo University Faculty of Medicine, Department of Anesthesiology and Pain 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)

IRB Contact (For public release)
Organization Juntendo University
Address 3-1-3, Hongo, Bunkyo-ku, Tokyo
Tel 03-3813-3111
Email h-okada@juntendo.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
2020 Year 12 Month 28 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 34
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 No longer recruiting
Date of protocol fixation
2020 Year 10 Month 20 Day
Date of IRB
2020 Year 11 Month 17 Day
Anticipated trial start date
2020 Year 11 Month 20 Day
Last follow-up date
2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This is a descriptive study. Treatment for each patient had been finished. Data collection and analysis will be held during the study period.

Management information
Registered date
2020 Year 12 Month 24 Day
Last modified on
2020 Year 12 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048863

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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