Predictability of Thromboelastography Parameters in Severe Post Partum Hemorrhage

Predictability of Thromboelastography Parameters in Severe Post Partum Hemorrhage : a Retrospective Study

The aim of the study is to determine if thromboelastography parameters can be predictive of severe post partum hemorrhage.

Study Overview

• Status: Completed
• Conditions: Post Partum Hemorrhage
• Intervention / Treatment: Diagnostic test: thromboelastography

• Study Type: Observational
• Enrollment (Actual): 100

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women presenting with a post partum hemorrhage

Description

Inclusion Criteria:

• Women presenting with a post partum hemorrhage
• needing sulprostone infusion
• during third trimester of pregnancy

Exclusion Criteria:

• known coagulation disorders

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Post Partum Hemorrhage; Patients presenting with a post partum hemorrhage. A thromboelastography analysis is realized at discretion of the anesthesiologist in charge	Diagnostic test: thromboelastography; TEG5000® : Kaolin and Functional Fibrinogen tests on native blood sample

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Calculated blood loss	Calculated blood loss at 24 hours after delivery (Sum of the volume of blood transfused and the volume of blood loss calculated by the decrease in hematocrit.)	during the 24 hours after delivery

Collaborators and Investigators

• Sponsor: Hôpital Armand Trousseau
• Investigators: Study Director: Agnes Rigouzzo, MD, Hopital Armand Trousseau

Publications and helpful links

General Publications

• Rigouzzo A, Louvet N, Favier R, Ore MV, Piana F, Girault L, Farrugia M, Sabourdin N, Constant I. Assessment of Coagulation by Thromboelastography During Ongoing Postpartum Hemorrhage: A Retrospective Cohort Analysis. Anesth Analg. 2020 Feb;130(2):416-425. doi: 10.1213/ANE.0000000000004422.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2012
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: March 30, 2017
• First Submitted That Met QC Criteria: February 27, 2018
• First Posted (Actual): February 28, 2018

Study Record Updates

• Last Update Posted (Actual): February 28, 2018
• Last Update Submitted That Met QC Criteria: February 27, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: thromboelastography
• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Obstetric Labor Complications; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Postpartum Hemorrhage
• Other Study ID Numbers: ArmandTrousseau

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