UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047657 |
|---|---|
| Receipt number | R000054334 |
| Scientific Title | Evaluation of the Quantra QStat system in obstetric and non-obstetric patients: prospective non-randomized study |
| Date of disclosure of the study information | 2022/05/06 |
| Last modified on | 2023/05/07 16:58:45 |
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Basic information
Public title
Evaluation of the Quantra QStat system in obstetric and non-obstetric patients: prospective non-randomized study
Acronym
Evaluation of the Quantra QStat system in obstetric and non-obstetric patients: prospective non-randomized study
Scientific Title
Evaluation of the Quantra QStat system in obstetric and non-obstetric patients: prospective non-randomized study
Scientific Title:Acronym
Evaluation of the Quantra QStat system in obstetric and non-obstetric patients: prospective non-randomized study
Region
| Japan |
Condition
Condition
pregnancy
Classification by specialty
| Obstetrics and Gynecology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Postpartum hemorrhage is a leading cause of maternal mortality worldwide. It is associated with hemostatic impairment which may deteriorate bleeding. To evaluate hemostasis is the key element of postpartum hemorrhage. Sonorheometry coagulation assay, Quantra Hemostasis Analyzer, is a point-of-care testing device which is recently introduced in clinical practice. This newer sonorheometry coagulation assay has been investigated for correlation between conventional viscoelastic testing, such as thromboslastometry and theomboelastography in these several years. Evidence is growing in cardiac surgery, however, investigation in obstetric patients is limited. In obstetric setting,Kodali et al. demonstrated the good correlation between clot stiffness and fibrinogen contribution to clot stiffness in Quantra and serum fibrinogen level when the sample blood from term parturients is diluted in vitro to simulate acquired hypofibrinogenemia.The Quantra QStat system includes tests to assess coagulation and clot lysis characteristics via the intrinsic and extrinsic pathways and includes a test with tranexamic acid.
The primary purpose of this study is to evaluate this new system in obstetric and non-obstetric population. The secondary purpose is to investigate the correlation with thromboelastography and the conventional coagulation tests.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Variables of Quantra Qstat system and correlation between obstetric and non-obstetric patients: clot time(CT), Clot stiffness (CS), platelet contribution to CS (PCS), fibrinogen contribution to CS (FCS), and Clot stability to lysis (CSL) .
Key secondary outcomes
Correlation with Quantra variables and TEG6s variables and conventional coagulation tests.
TEG6s variables: Clotting time (CK R), clot strength value (CRT MA) on the standard citrated kaolin assay, fibrinogen contribution to MA (CFF MA), and fibrinolysis (CRT LY30) .
conventional coagulation tests: PT, aPTT, INR, fibrinogen, antithrombin, and fibrin degenerating product.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
drawing 10 mL of blood from non-laboring parturients between 37 to 41 weeks of gestation .
Interventions/Control_2
For control group, 10 mL of blood is drawn from non-obstetric women.
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
1) age 18-45 years old at informed consent
2) diagnosed pregnant and registered for delivery in our hospital(obstetric group)
3) not pregnant and plans gynecological surgery at our hospital (control group)
4) informed and consented to the study
Key exclusion criteria
1)known coagulation abnormality and/or thrombocytopenia < 100 9/L
2) found coagulation abnormality and/or thrombocytopenia < 100 9/L at drawing blood
3) judged improper by the reseacher
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hisako |
| Middle name | |
| Last name | Okada |
Organization
Juntendo University Urayasu Hospital
Division name
Department of Anesthesiology and Pain Medicine
Zip code
2790021
Address
2-1-1, Tomioka, Urayasu, Chiba, 2790021
TEL
0473533111
h-okada@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Hisako |
| Middle name | |
| Last name | Okada |
Organization
Juntendo University Urayasu Hospital
Division name
Department of Anesthesiology and Pain Medicine
Zip code
2790021
Address
2-1-1, Tomioka, Urayasu, Chiba, 2790021
TEL
0473533111
Homepage URL
h-okada@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Heiwa Bussan
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo Clinical Research and Trial center
Address
3-1-3,Hongo,Bunkyo-ku,Tokyo 113-8431,Japan
Tel
03-3814-5672
jcrtc_operation@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
順天堂大学医学部附属浦安病院
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 05 | Month | 06 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 05 | Month | 05 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 20 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 05 | Month | 06 | Day |
Last modified on
| 2023 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054334
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