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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000047657
Receipt No. 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 2022/05/06

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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
Obsterics 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
Email 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
Email h-okada@juntendo.ac.jp

Sponsor
Institute Juntendo University
Institute
Department

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
Email 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 Preinitiation
Date of protocol fixation
2022 Year 05 Month 05 Day
Date of IRB
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
2022 Year 05 Month 06 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054334

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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