Postpartum HemorrhageINTEGRAL-HPPNCT06473233
Interest of TEG6S® in Reducing Transfusion Needs During Postpartum Haemorrhage
An observational study of Postpartum Hemorrhage, run by Centre Hospitalier Sud Francilien at 1 site in France.
Trial summary
The main objective of this study is to evaluate fibrinogen consumption, transfusion need, and other security outcomes in women with postpartum hemorrhage of 1000 mL or more, before and after the implementation of a TEG6S® device at a level III maternity unit (Centre Hospitalier Sud Francilien, Corbeil-Essonnes… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postpartum Hemorrhage
- What is being tested?
- TEG6S
- Type of treatment
- Medical device
- How many people
- 195 participants
- Where
- 1 siteFrance
- Study dates
- 9 Oct 2024to 6 Mar 2025
- 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: Adult women who gave birth at the level III maternity of Centre Hospitalier Sud Francilien and had postpartum haemorrhage greater than 1000mL or more.
Who may be able to join
- Woman of 18 years old or more
- Delivery at the level III maternity of Centre Hospitalier Sud Francilien (CHSF) (Corbeil-Essonnes, France) between 2022 and 2024, except deliveries during cyber-attack period at CHSF (from August 2022 to December 2022 included), due to uncertainty over the completeness of the data.
- Presenting postpartum hemorrhage with estimated blood loss of 1000mL or more
- No constitutional hemostasis anomaly
- No treatment interfering with hemostasis
- No use of blood products and/or pro-coagulant products before delivery
Who cannot join
- Patient informed of the research and refusing the use of the data
Trial locations and contacts
1 site in 1 country.
About this study
The main objective of this study is to evaluate fibrinogen consumption, transfusion need, and other security outcomes in women with postpartum hemorrhage of 1000 mL or more, before and after the implementation of a TEG6S® device at a level III maternity unit (Centre Hospitalier Sud Francilien, Corbeil-Essonnes, France).
Read the detailed description
Acquired obstetrical coagulopathy during massive postpartum hemorrhage (PPH) is a serious and frequent complication of delivery. It has been shown that fibrinogen levels are the first to fall during PPH, and that a level inferior to a threshold of 2g/L is strongly associated with progression to severe PPH, hemostatic impairment, transfusion, and invasive hemostatic procedures.
The clinical diagnosis of coagulopathy is difficult, and the biological diagnosis by usual laboratory tests is often delayed, leading to the empirical administration of fibrinogen and blood products, sometimes unnecessary.
The TEG6S® is a viscoelastic testing device performed on whole blood, which allows a reliable assessment of hemostasis and coagulation quality in about ten minutes.
The anomalies detected by the TEG6S® allow for the early diagnosis of acquired coagulopathy, especially hypofibrinogenemia. Its use during the management of PPH would therefore allow for transfusion savings and potential economic benefits, in addition to improving patient prognosis through early and appropriate treatment (including the absence of early "blind" treatment in the absence of coagulopathy).
- Conditions
- Postpartum Hemorrhage
- Being tested
- TEG6S
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEG6SDevice
Hemostatic management including one or more delocalized biology test with the TEG6S®, at the discretion of the responsible clinician
| Study group | Role | What they receive |
|---|---|---|
| Before TEG6S | Patients managed in a period of 12 months before the implementation of TEG6S® | |
| After TEG6S | Patients managed in a period of 12 months after the implementation of TEG6S® Receives: Device: TEG6S |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibrinogen consumption
Quantity of fibrinogen administered (in grams)
Measured: up to 24 hours
Secondary outcomes (11)
Total number of TEG6S®
Total number of TEG6S® carried out over a period of 12 months following its implementation
Measured: at 12 months
Estimated blood loss
Estimated total volume of blood loss during PPH, in milliliters, using a graduated bag and weight of blood-soaked materials
Measured: up to 24 hours
Calculated blood loss
Estimated total volume of blood loss during PPH, using the following formula = ([initial Ht - Ht H24] × total blood volume × 100/35) + compensated blood loss (CBL) ; with: total blood volume in milliliters = basis weight × 65 × 1.4, and CBL in milliliters, corresponding to the number of RBC concentrates transfused (1 RBC corresponds to approximately 500 mL of blood at 35% Ht).
Measured: up to 24 hours
Consumption of packed red blood cells (RBC)
Number of packed red blood cells used
Measured: up to 24 hours
Consumption of fresh frozen plasma (FFP)
Number of fresh frozen plasma (FFP) used
Measured: up to 24 hours
Invasive haemostatic procedure
Use of surgical and/or radio-interventional hemostasis (Bakri balloon, embolization, arterial ligation, uterine padding, hemostasis hysterectomy)
Measured: up to 24 hours
Maternal death
Occurrence of maternal death at hospital
Measured: until leaving the hospital
ICU admission
Any admission in an intensive care unit
Measured: until leaving the hospital
ICU length of stay
Total length of stay in an intensive care unit/critical care (in days)
Measured: until discharge from the intensive care unit
Total length of stay
Total length of stay in hospital (in days)
Measured: until discharge from the intensive care unit
Acute anemia
Occurrence of anemia following postpartum hemorrhage, defined by a decrease in hemoglobin level of 4g/dL or more at 24h following delivery, compared to the last hemoglobin level known before delivery
Measured: at 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start9 Oct 2024
- Primary completion6 Mar 2025
- Study completion6 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum 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
- Other
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Sud Francilien
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fatima BRIK, Principal investigator, Centre Hospitalier Sud Francilien
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06473233
- Sponsor's protocol ID
- 2024/0013
- Acronym
- INTEGRAL-HPP
- Status last verified
- Mar 2025
- First submitted
- 12 Jun 2024
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of TEG6S® in Reducing Transfusion Needs During Postpartum Haemorrhage
- ClinicalTrials.gov ID
- NCT06473233
- Acronym / sponsor ID
- INTEGRAL-HPP / 2024/0013
- Conditions
- Postpartum Hemorrhage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- Centre Hospitalier Sud FrancilienUniversity, hospital or other
- Study start
- 9 Oct 2024 (actual)
- Primary completion
- 6 Mar 2025 (actual)
- Study completion
- 6 Mar 2025 (actual)
- First posted
- 25 Jun 2024 (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 main objective of this study is to evaluate fibrinogen consumption, transfusion need, and other security outcomes in women with postpartum hemorrhage of 1000 mL or more, before and after the implementation of a TEG6S® device at a level III maternity unit (Centre Hospitalier Sud Francilien, Corbeil-Essonnes, France).
Detailed description
Acquired obstetrical coagulopathy during massive postpartum hemorrhage (PPH) is a serious and frequent complication of delivery. It has been shown that fibrinogen levels are the first to fall during PPH, and that a level inferior to a threshold of 2g/L is strongly associated with progression to severe PPH, hemostatic impairment, transfusion, and invasive hemostatic procedures.
The clinical diagnosis of coagulopathy is difficult, and the biological diagnosis by usual laboratory tests is often delayed, leading to the empirical administration of fibrinogen and blood products, sometimes unnecessary.
The TEG6S® is a viscoelastic testing device performed on whole blood, which allows a reliable assessment of hemostasis and coagulation quality in about ten minutes.
The anomalies detected by the TEG6S® allow for the early diagnosis of acquired coagulopathy, especially hypofibrinogenemia. Its use during the management of PPH would therefore allow for transfusion savings and potential economic benefits, in addition to improving patient prognosis through early and appropriate treatment (including the absence of early "blind" treatment in the absence of coagulopathy).
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Before TEG6S | – | –Patients managed in a period of 12 months before the implementation of TEG6S® |
| After TEG6S | – | Device: TEG6SPatients managed in a period of 12 months after the implementation of TEG6S® |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult women who gave birth at the level III maternity of Centre Hospitalier Sud Francilien and had postpartum haemorrhage greater than 1000mL or more.
Key inclusion criteria (6 listed)
- Woman of 18 years old or more
- Delivery at the level III maternity of Centre Hospitalier Sud Francilien (CHSF) (Corbeil-Essonnes, France) between 2022 and 2024, except deliveries during cyber-attack period at CHSF (from August 2022 to December 2022 included), due to uncertainty over the completeness of the data.
- Presenting postpartum hemorrhage with estimated blood loss of 1000mL or more
- No constitutional hemostasis anomaly
- No treatment interfering with hemostasis
Key exclusion criteria (1 listed)
- Patient informed of the research and refusing the use of the data
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 |
|---|---|---|
| TEG6SHemostatic management including one or more delocalized biology test with the TEG6S®, at the discretion of the responsible clinician | Device | After TEG6S |
Primary outcome
Fibrinogen consumption
Time frame: up to 24 hours
Quantity of fibrinogen administered (in grams)
11 secondary outcomes
Total number of TEG6S®
Time frame: at 12 months
Estimated blood loss
Time frame: up to 24 hours
Calculated blood loss
Time frame: up to 24 hours
Consumption of packed red blood cells (RBC)
Time frame: up to 24 hours
Consumption of fresh frozen plasma (FFP)
Time frame: up to 24 hours
Invasive haemostatic procedure
Time frame: up to 24 hours
Maternal death
Time frame: until leaving the hospital
ICU admission
Time frame: until leaving the hospital
ICU length of stay
Time frame: until discharge from the intensive care unit
Total length of stay
Time frame: until discharge from the intensive care unit
Acute anemia
Time frame: at 24 hours
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 14 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Postpartum Hemorrhage
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Measured Versus Hemoglobin-Calculated Postpartum Blood Loss in Waterbirth
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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.
Fatima BRIK principal investigator
Centre Hospitalier Sud Francilien
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postpartum Hemorrhage, run by Centre Hospitalier Sud Francilien at 1 site in France.
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 6 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 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Fibrinogen consumption (time frame: up to 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Mar 2025.