Coagulation Defect; PuerperalHPPTEG6SNCT03592303
Bedside Assessment of Coagulation in Post-partum Hemorrhage by Thromboelastography (TEG ®6S)
An observational study of Coagulation Defect; Puerperal and Post Partum Hemorrhage, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Postpartum hemorrhage (PPH) is one of the leading causes of maternal deaths. Its prognosis is directly influenced by the early diagnosis and treatment of the associated coagulopathy. In this context, fibrinogen concentration is the best predictor of a severe PPH. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Coagulation Defect; Puerperal, Post Partum Hemorrhage, Blood Protein Disorders
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2018to Mar 2019
- 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: Any pregnant patient with a normal pregnancy is eligible for possible participation in the study. Two patient groups will be included : * Pregnant women during labor * Women with PPH requiring biological evaluation of hemostasis
Who may be able to join
- Age ≥ 18 years old
- Patient with health insurance
- Group of patients during labor : any pregnant woman with a normal pregnancy in the delivery room.
- Group of patients with PPH: any woman with a normal pregnancy experiencing a PPH with blood loss greater than 500 mL and who requires a biological evaluation of haemostasis.
Who cannot join
- Coagulopathy pre-existing to pregnancy
- Medication that interferes with blood coagulation
- Hepato-cellular insufficiency
- Renal failure
- Psychiatric care patients
- Patient deprived of liberty by judicial or administrative decision
- Major patient undergoing legal protective measures
Trial locations and contacts
1 site in 1 country.
France1 site
Hopital Trousseau
Paris, 75012
Agnés Rigouzzo, Dr, +33171738969, agnes.rigouzzo@aphp.fr
Nicolas Louvet, Dr, +33171738946, nicolas.louvet@aphp.fr
About this study
Postpartum hemorrhage (PPH) is one of the leading causes of maternal deaths. Its prognosis is directly influenced by the early diagnosis and treatment of the associated coagulopathy. In this context, fibrinogen concentration is the best predictor of a severe PPH. The medical interest of thromboelastography/elastometry to early detect and guide the rapid correction of coagulopathy in PPH is regularly discussed.
The principal aim of this study is to evaluate the performance of a new hemostasis point of care device (thromboelastography - TEG ®6S) for the diagnosis of coagulopathy during PPH.
A secondary aim will be to determine the normal values of TEG6S at the end of a normal pregnancy.
Read the detailed description
Postpartum hemorrhage (PPH) is a complication of 5 to 10% of deliveries and is the leading cause of maternal mortality, all over the world. In France, as in other developed countries, 20% of maternal mortality is related to PPH complications with a high rate of avoidance (85%) due to inappropriate or delayed therapeutic measures). The management of PPH is based on recommendations highlighting the need for early detection and treatment of coagulopathy, which is predictive of the hemorrhage severity. The prognosis of the PPH is directly related to the rapidity of the coagulopathy treatment (30 to 60 minutes after diagnosis). Severe PPH is often associated with clotting disorders of either primary origin (disseminated intravascular coagulation) or secondary origin (coagulation factors loss due to hemorrhage). A hypofibrinogenemia < 2 g/L is the best predictor of a severe PPH with a positive predictive value of 100% . Similarly, abnormal coagulation tests appear to be predictive of the severity of the bleeding and the subsequent need for invasive procedures.
The assessment of coagulation is currently based on standard laboratory hemostasis tests, but with delayed time to obtain results, generally greater than 60 minutes. Therefore, early and fast assessment of hemostasis during PPH is essential to estimate the bleeding severity and allow early and adequate administration of pro-coagulant products, leading to an improved prognosis of PPH. The medical interest of thromboelastography (TEG) to early diagnose and guide the treatment of a coagulopathy in PPH is regularly discussed.
A previous observational study performed by our team in 2013 during PPH (95 patients and133 samples) compared the TEG 5000 parameters with the standard laboratory hemostasis tests. Our results confirm the good predictability of TEG 5000 for the early detection of a hypofibrinogenemia ≤ 2 g / l and/or thrombocytopenia ≤ 80 000 platelets / mm3 (AUC between 0.91 and 0.97). Among the biological parameters analyzed by the TEG 5000, the parameters K-MRTGG and FF-MRTGG (maximum rate of thrombus generation) were also evaluated. Their predictabilities were as good as the usual K-MA or FF-MA (comparable AUC) and were available more rapidly than usual parameters (3 ± 3 min for FF-MRTGG and 8 ± 3 min for K-MRTGG), allowing a very early evaluation of hemostasis.
The aim of this prospective observational study is therefore to evaluate the performance of a new delocalized hemostasis monitoring device (thromboelastography - TEG ®6S) for the diagnosis of coagulopathy during PPH.
- Conditions
- Coagulation Defect; Puerperal, Post Partum Hemorrhage, Blood Protein Disorders, Pregnancy Hemorrhage
- Keywords
- Post-partum haemorrhage, Thromboelastography, Coagulopathy, Fibrinogenemia
- Medical subject headings
- Hemostatic Disorders, Postpartum Hemorrhage, Blood Protein Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control | Any pregnant patient with a normal pregnancy is eligible for possible participation in the study. | |
| PPH group | Women with PPH requiring biological evaluation of hemostasis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance analysis of TEG6S kaolin parameters for the diagnosis of coagulation disorders in PPH.
The performance analysis of the parameters derived from the Kaolin test will be performed using ROC curves and a sensitivity and specificity calculation.
Measured: during the 24 hours after delivery
Secondary outcomes (10)
Performance analysis of TEG6S RapidTEG parameters for the diagnosis of coagulation disorders in PPH.
The performance analysis of the parameters derived from the RapidTEG test will be performed using ROC curves and a sensitivity and specificity calculation.
Measured: during the 24 hours after delivery.
Performance analysis of TEG6S Functional Fibrinogen parameters for the diagnosis of coagulation disorders in PPH.
The performance analysis of the parameters derived from Functional Fibrinogen test will be performed using ROC curves and a sensitivity and specificity calculation.
Measured: during the 24 hours after delivery.
Analysis of the correlation between the parameters provided by TEG6S and standard laboratory tests.
Analysis of correlation between the parameters of CFF test and laboratory tests.
Measured: during the 24 hours after delivery.
Analysis of the correlation between the parameters provided by TEG6S and standard laboratory tests.standard laboratory tests.
analysis of correlation between the parameters of CK test and laboratory tests.
Measured: during the 24 hours after delivery.
Analysis of the correlation between the parameters provided by TEG6S and standard laboratory tests.
analysis of correlation between the parameters of CRT test and laboratory tests.
Measured: during the 24 hours after delivery.
Performance of TEG6S parameters for predicting severe HPP
Blood loss will be calculated 24 hours after delivery, based on demographic data and hematocrit (Ht) values measured in the last month of pregnancy and 24 hours after delivery.
Measured: 24 hours after delivery.
Comparison of the time taken to obtain the different TEG6S parameters versus standard biology parameters.
The time taken to obtain the TEG6S parameter CK-MA will be measured. It corresponds to the time between the start of the analysis (including the start of the test) and the time the result is provided by the TEG6S.
Measured: during 24 hours after delivery
Comparison of the time taken to obtain the different TEG6S parameters versus standard biology parameters.
The time taken to obtain the TEG6S parameter CRT-MA will be measured. It corresponds to the time between the start of the analysis (including the start of the test) and the time the result is provided by the TEG6S.
Measured: during 24 hours after delivery
Comparison of the time taken to obtain the different TEG6S parameters versus standard biology parameters.
The time taken to obtain the TEG6S parameter FF-MA will be measured. It corresponds to the time between the start of the analysis (including the start of the test) and the time the result is provided by the TEG6S.
Measured: during 24 hours after delivery
Define normal reference values for TEG6S Thromboelastography in pregnant women during labor.
2.9 mL of additional blood will be collected for TEG6S analysis.
Measured: during 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 posted19 Jul 2018
- Study startAug 2018 (estimated)
- Primary completionAug 2018 (estimated)
- Study completionMar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coagulation Defect; PuerperalStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Agnès Rigouzzo, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03592303
- Sponsor's protocol ID
- NI17042J
- Other IDs
- 2017-A02347-46
- Acronym
- HPPTEG6S
- Status last verified
- May 2018
- First submitted
- 27 Apr 2018
- Last updated
- 19 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bedside Assessment of Coagulation in Post-partum Hemorrhage by Thromboelastography (TEG ®6S)
- ClinicalTrials.gov ID
- NCT03592303
- Acronym / sponsor ID
- HPPTEG6S / NI17042J
- Conditions
- Coagulation Defect; Puerperal, Post Partum Hemorrhage, Blood Protein Disorders, Pregnancy Hemorrhage
- Keywords
- Post-partum haemorrhage, Thromboelastography, Coagulopathy, Fibrinogenemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Aug 2018 (estimated)
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 19 Jul 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.
Postpartum hemorrhage (PPH) is one of the leading causes of maternal deaths. Its prognosis is directly influenced by the early diagnosis and treatment of the associated coagulopathy. In this context, fibrinogen concentration is the best predictor of a severe PPH. The medical interest of thromboelastography/elastometry to early detect and guide the rapid correction of coagulopathy in PPH is regularly discussed.
The principal aim of this study is to evaluate the performance of a new hemostasis point of care device (thromboelastography - TEG ®6S) for the diagnosis of coagulopathy during PPH.
A secondary aim will be to determine the normal values of TEG6S at the end of a normal pregnancy.
Detailed description
Postpartum hemorrhage (PPH) is a complication of 5 to 10% of deliveries and is the leading cause of maternal mortality, all over the world. In France, as in other developed countries, 20% of maternal mortality is related to PPH complications with a high rate of avoidance (85%) due to inappropriate or delayed therapeutic measures). The management of PPH is based on recommendations highlighting the need for early detection and treatment of coagulopathy, which is predictive of the hemorrhage severity. The prognosis of the PPH is directly related to the rapidity of the coagulopathy treatment (30 to 60 minutes after diagnosis). Severe PPH is often associated with clotting disorders of either primary origin (disseminated intravascular coagulation) or secondary origin (coagulation factors loss due to hemorrhage). A hypofibrinogenemia < 2 g/L is the best predictor of a severe PPH with a positive predictive value of 100% . Similarly, abnormal coagulation tests appear to be predictive of the severity of the bleeding and the subsequent need for invasive procedures.
The assessment of coagulation is currently based on standard laboratory hemostasis tests, but with delayed time to obtain results, generally greater than 60 minutes. Therefore, early and fast assessment of hemostasis during PPH is essential to estimate the bleeding severity and allow early and adequate administration of pro-coagulant products, leading to an improved prognosis of PPH. The medical interest of thromboelastography (TEG) to early diagnose and guide the treatment of a coagulopathy in PPH is regularly discussed.
A previous observational study performed by our team in 2013 during PPH (95 patients and133 samples) compared the TEG 5000 parameters with the standard laboratory hemostasis tests. Our results confirm the good predictability of TEG 5000 for the early detection of a hypofibrinogenemia ≤ 2 g / l and/or thrombocytopenia ≤ 80 000 platelets / mm3 (AUC between 0.91 and 0.97). Among the biological parameters analyzed by the TEG 5000, the parameters K-MRTGG and FF-MRTGG (maximum rate of thrombus generation) were also evaluated. Their predictabilities were as good as the usual K-MA or FF-MA (comparable AUC) and were available more rapidly than usual parameters (3 ± 3 min for FF-MRTGG and 8 ± 3 min for K-MRTGG), allowing a very early evaluation of hemostasis.
The aim of this prospective observational study is therefore to evaluate the performance of a new delocalized hemostasis monitoring device (thromboelastography - TEG ®6S) for the diagnosis of coagulopathy during PPH.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | –Any pregnant patient with a normal pregnancy is eligible for possible participation in the study. |
| PPH group | – | –Women with PPH requiring biological evaluation of hemostasis |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any pregnant patient with a normal pregnancy is eligible for possible participation in the study. Two patient groups will be included : * Pregnant women during labor * Women with PPH requiring biological evaluation of hemostasis
Key inclusion criteria (4 listed)
- Age ≥ 18 years old
- Patient with health insurance
- Group of patients during labor : any pregnant woman with a normal pregnancy in the delivery room.
- Group of patients with PPH: any woman with a normal pregnancy experiencing a PPH with blood loss greater than 500 mL and who requires a biological evaluation of haemostasis.
Key exclusion criteria (7 listed)
- Coagulopathy pre-existing to pregnancy
- Medication that interferes with blood coagulation
- Hepato-cellular insufficiency
- Renal failure
- Psychiatric care patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Performance analysis of TEG6S kaolin parameters for the diagnosis of coagulation disorders in PPH.
Time frame: during the 24 hours after delivery
The performance analysis of the parameters derived from the Kaolin test will be performed using ROC curves and a sensitivity and specificity calculation.
10 secondary outcomes
Performance analysis of TEG6S RapidTEG parameters for the diagnosis of coagulation disorders in PPH.
Time frame: during the 24 hours after delivery.
Performance analysis of TEG6S Functional Fibrinogen parameters for the diagnosis of coagulation disorders in PPH.
Time frame: during the 24 hours after delivery.
Analysis of the correlation between the parameters provided by TEG6S and standard laboratory tests.
Time frame: during the 24 hours after delivery.
Analysis of the correlation between the parameters provided by TEG6S and standard laboratory tests.standard laboratory tests.
Time frame: during the 24 hours after delivery.
Analysis of the correlation between the parameters provided by TEG6S and standard laboratory tests.
Time frame: during the 24 hours after delivery.
Performance of TEG6S parameters for predicting severe HPP
Time frame: 24 hours after delivery.
Comparison of the time taken to obtain the different TEG6S parameters versus standard biology parameters.
Time frame: during 24 hours after delivery
Comparison of the time taken to obtain the different TEG6S parameters versus standard biology parameters.
Time frame: during 24 hours after delivery
Comparison of the time taken to obtain the different TEG6S parameters versus standard biology parameters.
Time frame: during 24 hours after delivery
Define normal reference values for TEG6S Thromboelastography in pregnant women during labor.
Time frame: during 24 hours after delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2018.
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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.
Agnès Rigouzzo principal investigator
Assistance Publique - Hôpitaux de Paris
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 Coagulation Defect; Puerperal and Post Partum Hemorrhage, run by Assistance Publique - Hôpitaux de Paris 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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 19 Jul 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Agnès Rigouzzo (+33171738969, agnes.rigouzzo@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance analysis of TEG6S kaolin parameters for the diagnosis of coagulation disorders in PPH. (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?
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 19 Jul 2018.