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Clinical Trials/NCT05336838
NCT05336838UnknownNot Applicable

Use of Quantra® System in Clinical Practice to Improve Management of Post-partum Haemorrhage : a Prospective Study

University Hospital, Montpellier0 sites60 target enrollmentStarted: May 1, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
60
Primary Endpoint
Comparison of delay in obtaining Quantra Fibrinogen Clot Stiffness result to standard fibrinogen level result

Study Overview

Brief Summary

Post partum haemorrhage is a concerning situation in maternity wards, though it is not the first cause of maternal mortality anymore.

It has been already shown that low fibrinogen level is a major predictive factor of massive bleeding after delivery.

In this situation, the early knowledge of fibrinogen level could enhance care of women experiencing post partum haemorrhage.

In a cohort of women suffering from post partum haemorrhage, this study will evaluate whether assessing fibrinogen level would be faster using the Quantra® system than the standard coagulation test.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Women ≥ 18 years old Experiencing post partum haemorrhage ≥ 500 mL Within 24 hours after delivery

Exclusion Criteria

  • Previous anemia ≤ 7g/dL
  • Known bleeding disorders
  • Ongoing antiplatelets treatment
  • Ongoing anticoagulant treatment

Outcomes

Primary Outcomes

Comparison of delay in obtaining Quantra Fibrinogen Clot Stiffness result to standard fibrinogen level result

Time Frame: When post partum haemorrhage occurred, within 24 hours after delivery

Comparison of delay in obtaining Quantra Fibrinogen Clot Stiffness result to standard fibrinogen level result

Secondary Outcomes

  • Rate of satisfaction of anesthetist in charge of patient assessed by Lickert scale(When post partum haemorrhage occurred, within 24 hours after delivery)
  • Comparison of Quantra Clot Time result to Standard Kaolin Clotting time result(When post partum haemorrhage occurred, within 24 hours after delivery)
  • Comparison of level of fibrinogen assessed by Quantra Fibrinogen Clot Stiffness to level of fibrinogen assessed by standard coagulation test(When post partum haemorrhage occurred, within 24 hours after delivery)
  • Comparison of Platelet Clot Stiffness result to standard platelet count result(When post partum haemorrhage occurred, within 24 hours after delivery)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

GRENIE

Doctor

University Hospital, Montpellier

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