UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042842 |
|---|---|
| Receipt number | 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 | 2024/06/22 15:07:18 |
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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
| Obstetrics 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
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
h-okada@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Faculty of Medicine, Department of Anesthesiology and Pain Medicine
Institute
Department
Personal name
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
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
https://jsa-shoroku.jp/search/detail_program/id:4165
Number of participants that the trial has enrolled
34
Results
Critical bleeding was declared and fibrinogen replacement therapy was performed in 25 patients. Blood loss was group C (median 3197 g) < group F (3243 g) < group CF (5704 g). Estimated total fibrinogen replacement by fibrinogen concentrates was group C (median 879 mg) < group F (3000 mg) < group CF (3842 mg). Fibrinogen levels were measured in all patients before fibrinogen replacement therapy, and all but three patients in group F had fibrinogen levels below 200 mg/dL.
Results date posted
| 2022 | Year | 12 | Month | 26 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Hisako Okada, who had applied to be the principal investigator, was the principal investigator at the main hospital because of her graduate school registration, but the hospital where she currently works was changed to Urayasu Hospital. Therefore, the principal investigator is now Professor Hiroyuki Sumikura of the main hospital, and Hisako Okada is the principal investigator of the Urayasu Hospital.
The manuscript for submission is currently being prepared. Considering the possibility that the paper may not be accepted by the original deadline of December 31, 2022, the research period was extended by one year.
Date of the first journal publication of results
Baseline Characteristics
Background: Our institution has been using dried human fibrinogen (F) for postpartum excessive bleeding for some time, but cryoprecipitate (C) has also been available since 2015 with the cooperation of the Blood Transfusion Department. The purpose of this study was to verify whether fibrinogen replacement therapy was appropriately selected at our institution.
Participant flow
Methods: A total of 6,610 patients who delivered at our facility between April 2015 and August 2020 were included in the study. Data were collected from electronic medical records and retrospectively reviewed for 14 patients who received C and 25 who received F for fibrinogen replacement therapy for excessive postpartum hemorrhage.
Adverse events
none
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2022 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 12 | Month | 31 | Day |
Other
Other related information
Published. Hisako OKADA, Shuko NOJIRI, Adila YAHKUP, Atsuo ITAKURA, Hiroyuki SUMIKURA. Appropriate Use of Fibrinogen Concentrate for Critical Postpartum Hemorrhage: A Single-center
Retrospective Observational Study. Bunben to Masui 2023;105:2-10
Management information
Registered date
| 2020 | Year | 12 | Month | 24 | Day |
Last modified on
| 2024 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048863
