Postpartum Hemorrhage Clinical Trial
— FIB-HPPSOfficial title:
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
NCT number | NCT06255002 |
Other study ID # | APHP231640 |
Secondary ID | |
Status | Not yet recruiting |
Phase | |
First received | |
Last updated | |
Start date | March 2024 |
Est. completion date | March 2025 |
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.
Status | Not yet recruiting |
Enrollment | 40 |
Est. completion date | March 2025 |
Est. primary completion date | March 2025 |
Accepts healthy volunteers | |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Hôpital Cochin Maternité Port Royal | Paris | |
France | Hôpital Necker-Enfants Malades | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
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Deleu F, Deneux-Tharaux C, Chiesa-Dubruille C, Seco A, Bonnet MP; EPIMOMS study Group. Fibrinogen concentrate and maternal outcomes in severe postpartum hemorrhage: A population-based cohort study with a propensity score-matched analysis. J Clin Anesth. 2022 Oct;81:110874. doi: 10.1016/j.jclinane.2022.110874. Epub 2022 Jun 2. — View Citation
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Green L, Knight M, Seeney F, Hopkinson C, Collins PW, Collis RE, Simpson NA, Weeks A, Stanworth SJ. The haematological features and transfusion management of women who required massive transfusion for major obstetric haemorrhage in the UK: a population based study. Br J Haematol. 2016 Feb;172(4):616-24. doi: 10.1111/bjh.13864. Epub 2015 Dec 18. — View Citation
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Jokinen S, Kuitunen A, Uotila J, Yli-Hankala A. Thromboelastometry-guided treatment algorithm in postpartum haemorrhage: a randomised, controlled pilot trial. Br J Anaesth. 2023 Feb;130(2):165-174. doi: 10.1016/j.bja.2022.10.031. Epub 2022 Dec 7. — View Citation
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* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Agreement between fibrinogen measurement by qLabs®FIB and by the Clauss method | 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 | Evaluation of the ease of use of qLabs®FIB by the anesthesia team | 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 | |
Secondary | Evaluation of the time taken to obtain the fibrinogen concentration using the 2 methods | 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 | |
Secondary | Evaluation of measurement failure by qLabs®FIB | 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 |
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