Concordance Between the Measurement of Whole Blood Fibrinogen by the qLabs®FIB Analyzer and Its Measurement by Conventional Method (Clauss Fibrinogen) in the Context of Severe Postpartum Haemorrhage (FIB-HPPS)

February 9, 2024 updated by: Assistance Publique - Hôpitaux de Paris

Concordance Between the Measurement of Whole Blood Fibrinogen by the qLabs®FIB Analyzer and Its Measurement by Conventional Method (Clauss Fibrinogen) in the Context of Severe Postpartum Haemorrhage: a Prospective Multicenter Non-interventional Study

In France in 2021, 11.6% of deliveries were complicated by a postpartum haemorrhage (PPH), including 3.0% by severe PPH (the bleeding volume exceeds 1000 ml). Severe PPH is the 5th cause of maternal death (8.4% or 1.2 deaths per 100,000 live births). These deaths were considered preventable in 90% of cases. A plasma fibrinogen concentration below 2 g/L is considered as a critical threshold which constitutes a marker of severity of PPH and is significantly associated with the occurrence of severe PPH. Measuring the concentration of fibrinogen using a rapid test, simple to perform and interpret, available in the delivery room could optimize the management of severe PPH. The qLabs®FIB analyzer distributed by the Stago Biocare laboratory for the rapid determination of the fibrinogen concentration at the patient's bedside could meet this objective.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

In France in 2021, 11.6% of deliveries were complicated by postpartum hemorrhage (PPH), including 3.0% by severe PPH (the bleeding volume exceeds 1000 ml). Severe PPH is the 5th cause of maternal death (8.4% or 1.2 deaths per 100,000 live births). These deaths were considered preventable in 90% of cases. A plasma fibrinogen concentration below 2 g/L is considered as a critical threshold which constitutes a marker of severity of PPH and is significantly associated with the occurrence of severe PPH. Measuring the concentration of fibrinogen using a rapid test, simple to perform and interpret, available in the delivery room could optimize the management of severe PPH. The qLabs®FIB analyzer distributed by Stago Biocare laboratory for the rapid determination of the fibrinogen concentration at the patient's bedside could meet this objective.

The hypothesis of the study is a concordance between the measurement of fibrinogen by the qLabs®FIB Monitoring system and by the Clauss fibrinogen assay in laboratory to identify patients with a fibrinogen level < 2 g/L.

The prospects are to provide an easy-to-use delocalized biology tool for early diagnosis of a fibrinogen concentration < 2g predictive of an unfavorable evolution in the context of severe PPH.

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Hawa KEITA-MEYER, MD-PhD
  • Phone Number: +33 1 44 49 42 06
  • Email: hawa.keita@aphp.fr

Study Locations

  • France
      • Paris, France, 75015
        • Hôpital Necker-Enfants Malades
        • Sub-Investigator:
          • Myriam Brebion, MD
        • Contact:
        • Principal Investigator:
          • Marine DRIESSEN, MD
        • Principal Investigator:
          • Delphine BORGEL, MD
        • Principal Investigator:
          • Dominique LASNE, MD
      • Paris, France, 75014
        • Hôpital Cochin Maternité Port Royal
        • Contact:
        • Sub-Investigator:
          • Catherine FISCHER, MD
        • Sub-Investigator:
          • Georges MION, MD
        • Sub-Investigator:
          • Mégane RAINEAU, MD
        • Principal Investigator:
          • Camille LE RAY, MD
        • Principal Investigator:
          • Jérôme DUCHEMIN, MD
        • Principal Investigator:
          • Valérie PROULLE, MD
        • Principal Investigator:
          • Ladislas CAPDEVILA, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients giving birth in the two type 3 maternity wards of the Paris Center University Hospital Group : Necker-Enfants Malades et Cochin Port Royal (APHP) and with severe postpartum hemorrhage.

Description

Inclusion Criteria:

Adult patients having been informed of the study and not having objected to their participation and treated for severe postpartum haemorrhage defined as bleeding greater than 1000 ml within 24 hours postpartum, whatever the route delivery (vaginal route and caesarean section).

Exclusion Criteria:

  • Opposition to participation in the study
  • Presence of a constitutional fibrinogen deficiency
  • Patients under guardianship or curatorship

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients
Patients giving birth in the Cochin Port Royal and Necker Enfants Malades (APHP) maternity units and cared for severe postpartum haemorrhage defined as bleeding greater than 1000 ml within 24 hours of postpartum, regardless of the route of delivery (vaginal delivery and cesarean section).
Biological: Fibrinogen concentration by the qLabs®FIB Monitoring system
A drop of blood (~15 μL) is taken from the blood sample for the complete haemostasis assessment (prothrombin level, activated partial thromboplastin time, fibrinogen). This assessment is part of the usual management of severe postpartum haemorrhage. It is carried out urgently in the hospital's medical biology laboratory at the start of treatment (T1) and during or at the end of treatment of the haemorrhage (T2). This drop of blood will allow the measurement of the fibrinogen concentration by the qLabs®FIB Monitoring system for the study at these two times.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Agreement between fibrinogen measurement by qLabs®FIB and by the Clauss method
Time Frame: Through study completion, an average of 1 year
Calculation of the average bias and the 95% limits of agreement between the measurement of qLabs®FIB fibrinogen in the delivery room and Clauss fibrinogen at the medical biology laboratory using the Bland and Altman graphic method. A difference of 0.1 g between the two techniques will be considered acceptable to identify patients with a fibrinogen level < 2 g/L.
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the ease of use of qLabs®FIB by the anesthesia team
Time Frame: Through study completion, an average of 1 year
Ease of use of the qLabs®FIB assessed by a numerical scale between 0-10 by the anesthesia team.
Through study completion, an average of 1 year
Evaluation of the time taken to obtain the fibrinogen concentration using the 2 methods
Time Frame: Through study completion, an average of 1 year
Time to obtain the fibrinogen result with the qLabs®FIB and the Clauss method at the medical biology laboratory using the emergency circuit proposed by the laboratory.
Through study completion, an average of 1 year
Evaluation of measurement failure by qLabs®FIB
Time Frame: Through study completion, an average of 1 year
Number of failed fibrinogen measurements with qLabs®FIB defined as the absence of results returned by the monitor.
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Hawa KEITA-MEYER, MD-PhD, Assistance Publique - Hôpitaux de Paris
  • Study Director: Marc SAMAMA, MD-PhD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

December 5, 2023

First Submitted That Met QC Criteria

February 9, 2024

First Posted (Actual)

February 12, 2024

Study Record Updates

Last Update Posted (Actual)

February 12, 2024

Last Update Submitted That Met QC Criteria

February 9, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP231640

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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