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Predictability of Thromboelastography Parameters in Severe Post Partum Hemorrhage

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ClinicalTrials.gov Identifier: NCT03449420
Recruitment Status : Completed
First Posted : February 28, 2018
Last Update Posted : February 28, 2018
Sponsor:
Information provided by (Responsible Party):
Pr Isabelle CONSTANT, Hôpital Armand Trousseau

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

Condition or disease Intervention/treatment
Post Partum Hemorrhage Diagnostic Test: thromboelastography

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Predictability of Thromboelastography Parameters in Severe Post Partum Hemorrhage : a Retrospective Study
Actual Study Start Date : January 2012
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Calculated blood loss [ Time Frame: during the 24 hours after delivery ]
    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.)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   pregnant women
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women presenting with a post partum hemorrhage
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • known coagulation disorders

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03449420


Sponsors and Collaborators
Hôpital Armand Trousseau
Investigators
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Study Director: Agnes Rigouzzo, MD Hôpital Armand Trousseau

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Responsible Party: Pr Isabelle CONSTANT, Head of Anesthesiology Department, Hôpital Armand Trousseau
ClinicalTrials.gov Identifier: NCT03449420     History of Changes
Other Study ID Numbers: ArmandTrousseau
First Posted: February 28, 2018    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pr Isabelle CONSTANT, Hôpital Armand Trousseau:
thromboelastography

Additional relevant MeSH terms:
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Hemorrhage
Postpartum Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage