Post Partum HemorrhageNCT03449420
Predictability of Thromboelastography Parameters in Severe Post Partum Hemorrhage
An observational study of Post Partum Hemorrhage, run by Hôpital Armand Trousseau.
Trial summary
The aim of the study is to determine if thromboelastography parameters can be predictive of severe post partum hemorrhage. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Post Partum Hemorrhage
- What is being tested?
- thromboelastography
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Jul 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women presenting with a post partum hemorrhage
Who may be able to join
- Women presenting with a post partum hemorrhage
- needing sulprostone infusion
- during third trimester of pregnancy
Who cannot join
- known coagulation disorders
About this study
Official title: 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.
- Conditions
- Post Partum Hemorrhage
- Being tested
- thromboelastography
- Keywords
- thromboelastography
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thromboelastographyDiagnostic test
TEG5000® : Kaolin and Functional Fibrinogen tests on native blood sample
| Study group | Role | What they receive |
|---|---|---|
| Post Partum Hemorrhage | Patients presenting with a post partum hemorrhage. A thromboelastography analysis is realized at discretion of the anesthesiologist in charge Receives: Diagnostic Test: thromboelastography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.)
Measured: during the 24 hours after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2018
- Study startJan 2012
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Partum HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital Armand Trousseau
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pr Isabelle CONSTANT, Hôpital Armand Trousseau
- Investigators
- Agnes Rigouzzo, MD, Study director, Hôpital Armand Trousseau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03449420
- Sponsor's protocol ID
- ArmandTrousseau
- Status last verified
- Feb 2018
- First submitted
- 30 Mar 2017
- Last updated
- 28 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 31567472
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictability of Thromboelastography Parameters in Severe Post Partum Hemorrhage : a Retrospective Study
- ClinicalTrials.gov ID
- NCT03449420
- Acronym / sponsor ID
- ArmandTrousseau
- Conditions
- Post Partum Hemorrhage
- Keywords
- thromboelastography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hôpital Armand TrousseauUniversity, hospital or other
- Study start
- Jan 2012 (actual)
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 28 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to determine if thromboelastography parameters can be predictive of severe post partum hemorrhage.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post Partum Hemorrhage | – | Diagnostic Test: thromboelastographyPatients presenting with a post partum hemorrhage. A thromboelastography analysis is realized at discretion of the anesthesiologist in charge |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women presenting with a post partum hemorrhage
Key inclusion criteria (3 listed)
- Women presenting with a post partum hemorrhage
- needing sulprostone infusion
- during third trimester of pregnancy
Key exclusion criteria (1 listed)
- known coagulation disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| thromboelastographyTEG5000® : Kaolin and Functional Fibrinogen tests on native blood sample | Diagnostic test | Post Partum Hemorrhage |
Primary outcome
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.)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2018.
- Derived from this study: PubMed 31567472Rigouzzo 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Agnes Rigouzzo, MD study director
Hôpital Armand Trousseau
Questions about this trial
What is this clinical trial studying?
An observational study of Post Partum Hemorrhage, run by Hôpital Armand Trousseau.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Calculated blood loss (time frame: during the 24 hours after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03449420, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2018.