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Evaluation of the Quantra QStat system in obstetric and non-obstetric patients: prospective non-randomized study

Evaluation of the Quantra QStat system in obstetric and non-obstetric patients: prospective non-randomized study - Evaluation of the Quantra QStat system in obstetric and non-obstetric patients: prospective non-randomized study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000047657
Enrollment
60
Registered
2022-05-06
Start date
2022-07-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pregnancy

Interventions

drawing 10 mL of blood from non-laboring parturients between 37 to 41 weeks of gestation . For control group, 10 mL of blood is drawn from non-obstetric women.

Sponsors

Juntendo University
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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) .

Secondary

MeasureTime frame
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.

Countries

Japan

Contacts

Public ContactHisako Okada

Juntendo University Urayasu Hospital Department of Anesthesiology and Pain Medicine

h-okada@juntendo.ac.jp0473533111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026