ThrombocytopeniaNCT07616349
Prediction of Platelet Function Using Viscoelastic Test (ROTEM® Sigma) in Obstetric Anesthesia.
An observational study of Thrombocytopenia and Postpartum Haemorrhage (PPH), run by Nicolas Brogly at 1 site in Spain.
Trial summary
This prospective observational, non-interventional, single-center study aims to evaluate whether the viscoelastic parameter PLTEM, derived from ROTEM® sigma testing (EXTEM-A5 minus FIBTEM-A5), can accurately estimate platelet count in obstetric patients with thrombocytopenia and/or severe postpartum hemorrhage. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Thrombocytopenia, Postpartum Haemorrhage (PPH)
- How many people
- 85 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2026to 1 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Cohort of consecutive consenting patients with suspicion and/or confirmed thrombocytopenia admitted in the labor ward, the obstetric operating room or the obstetric post anaesthetic care unit for delivery in a tertiary university hospital in Madrid-Spain for a period of 1 year.
Who may be able to join
- Parturients with a suspicion or confirmed thrombocytopenia before delivery (platelet count < 120x10^9/L),
- Parturients with severe postpartum haemorrhage (blood loss >1500 mL) with a suspicion of thrombocytopenia.
Who cannot join
- parturient age under 18 years;
- refusal to participate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital General Universitario Gregorio Marañón
Madrid, 28007
Aránzazu Rodríguez Catalán, MD, +34 627476391, arodriguezc293dd6@salud.madrid.org
About this study
Official title: Prediction of Platelet Function Using Viscoelastic Test (ROTEM® Sigma) in Obstetric Anesthesia: an Prospective Observational Study
This prospective observational, non-interventional, single-center study aims to evaluate whether the viscoelastic parameter PLTEM, derived from ROTEM® sigma testing (EXTEM-A5 minus FIBTEM-A5), can accurately estimate platelet count in obstetric patients with thrombocytopenia and/or severe postpartum hemorrhage.
The study will include pregnant women older than 18 years managed during labor and delivery at the Hospital General Universitario Gregorio Marañón, Madrid (Spain).
The primary objective is to validate the clinical usefulness of PLTEM as a rapid point-of-care tool to support clinical decision-making regarding neuraxial anesthesia and transfusion management in obstetric emergencies.
Read the detailed description
Obstetric hemorrhage remains the leading cause of maternal mortality worldwide. In Spain, recent studies estimate an incidence between 2% and 5%. The main causes include uterine atony, genital tract trauma, retained placental tissue, and coagulation disorders. Early recognition and management of coagulation abnormalities are essential to reduce maternal morbidity and mortality.
Viscoelastic testing using rotational thromboelastometry (ROTEM® sigma) provides dynamic real-time assessment of coagulation and has become increasingly integrated into obstetric hemorrhage management algorithms. Platelet function plays a major role in clot formation, and impairment of platelet quantity or function may influence transfusion strategies and the safety of neuraxial anesthesia techniques.
The PLTEM parameter (Platelet contribution to clot firmness) estimates platelet contribution to clot strength and is calculated as the difference between EXTEM-A5 and FIBTEM-A5. In other clinical settings, PLTEM-derived measurements have demonstrated the ability to estimate platelet count with good accuracy. However, evidence validating its utility in obstetric patients remains limited.
The hypothesis of this study is that PLTEM may provide a reliable and rapid estimation of platelet count in urgent obstetric settings, thereby optimizing clinical decision-making, facilitating safer neuraxial anesthesia management, and improving transfusion practices.
This is a prospective, observational, non-interventional, single-center study conducted at the Hospital General Universitario Gregorio Marañón, Madrid (Spain). The study population will include pregnant women older than 18 years attended during labor and delivery who present with thrombocytopenia of any etiology and/or develop postpartum hemorrhage greater than 1,500 mL. Patients who decline participation will be excluded.
Clinical and laboratory data will be collected as part of routine care during the intrapartum and immediate postpartum periods. Variables recorded will include demographic characteristics, conventional laboratory parameters, ROTEM® variables, neuraxial anesthesia procedures, quantification of hemorrhage, transfusion requirements, need for reintervention, and maternal complications.
The primary objective is to validate the clinical usefulness of PLTEM in the obstetric setting and assess its correlation with conventional platelet count measurements. Secondary objectives include evaluation of additional ROTEM® parameters associated with coagulation abnormalities, assessment of transfusion requirements and hemorrhagic outcomes, and exploration of the relationship between thrombocytopenia, fibrinogen levels, and other factors contributing to obstetric coagulopathy.
The estimated minimum sample size is 85 patients, adjusted for an anticipated 20% loss rate. Statistical analyses will be performed using SPSS version 29.0. The study period will extend from protocol approval until completion of recruitment, with an anticipated completion date of December 2026.
- Conditions
- Thrombocytopenia, Postpartum Haemorrhage (PPH)
- Being tested
- No Intervention: Observational Cohort
- Keywords
- Platelet function, viscoelastic test, Obstetric hemostasis, thrombocytopenia, postpartum haemorrhage, PPH, ROTEM
- Medical subject headings
- Thrombocytopenia, Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention: Observational CohortOther
No intervention: observational study
| Study group | Role | What they receive |
|---|---|---|
| Obstetric Patients with confirmed or suspicion of thrombocytopenia | The study will include all the consecutive consenting parturients admitted to our maternal unit in the inclusion period with the following inclusion and exclusion criteria.
Inclusion criteria: Parturients with a suspicion or confirmed thrombocytopenia before delivery (platelet count < 120x10^9/L), Parturients with severe postpartum haemorrhage (blood loss >1500 mL) with a suspicion of thrombocytopenia.
Exclusion criteria: parturient age under 18 years; refusal to participate Receives: Other: No Intervention: Observational Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the correlation between PLTEM value and platelet count on hemogram
A blood sample will be extracted in patients at risk or with confirmed thrombcytopenia. A simultaneous platelet count (standard biological test) and ROTEM sigma viscoelastic test will be performed. The correlation between PLTEM5 (EXTEM A5 - FIBTEM A5), PLTEM10 (EXTEM A10 - FIBTEM A10) and platelet count will be determined.
Measured: At admission to the labour ward in case of thrombocytopenia inferior to 120,000 /mm^3 platelets in the third trimester of pregnancy, or at diagnosis of a severe Post-Partum Hemorrhage > 1,500 mL, until 24 hours after delivery or cesarean delivery.
Secondary outcomes (2)
Relationship between ROTEM® parameters, thrombocytopenia, and fibrinogen levels
To assess the correlation between ROTEM® sigma-derived parameters (FIBTEM, EXTEM, and INTEM) and standard coagulation assays, including: Clauss fibrinogen, prothrombin time (PT), and activated partial thromboplastin time (aPTT), in obstetric patients with thrombocytopenia and/or postpartum hemorrhage ≥1,500 mL, with the aim of characterizing the coagulopathy profile in these scenarios, with particular attention to hypofibrinogenemia and platelet function.
Measured: From admission to the labour ward or from diagnosis of severe postpartum hemorrhage (>1,500 mL), through 24 hours postpartum.
PLTEM threshold for safe neuraxial anesthesia in thrombocytopenic obstetric patients
To assess whether a specific PLTEM threshold can be determined with ROTEM® sigma to identify obstetric patients above the established safety platelet count threshold for neuroaxial anesthesia (≥ 70 × 10⁹/L) in a clinically useful timeframe compared to conventional laboratory test.
Measured: At admission to the labour ward.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start1 May 2026
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for ThrombocytopeniaStudies 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
- Prospective
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nicolas Brogly
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nicolas Brogly, Hospital General Universitario Gregorio Marañon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07616349
- Sponsor's protocol ID
- ROTEMPLAQ
- Status last verified
- May 2026
- First submitted
- 28 Apr 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This was not considered in the design of the research.
Publications
Bell SF, Kitchen T, John M, Scarr C, Kelly K, Bailey C, James K, Watkins A, Macgillivray E, Edey T, Greaves K, Volikas I, Tozer J, Sengupta N, Francis C, Collis R, Collins P. Designing and implementing an all Wales postpartum haemorrhage quality improvement project: OBS Cymru (the Obstetric Bleeding Strategy for Wales). BMJ Open Qual. 2020 Apr;9(2):e000854. doi: 10.1136/bmjoq-2019-000854.
PubMed 32273281Scala E, Coutaz C, Gomez F, Alberio L, Marcucci C. Comparison of ROTEM Sigma to Standard Laboratory Tests and Development of an Algorithm for the Management of Coagulopathic Bleeding in a Tertiary Center. J Cardiothorac Vasc Anesth. 2020 Mar;34(3):640-649. doi: 10.1053/j.jvca.2019.10.016. Epub 2019 Oct 11.
PubMed 31699598Ji SM, Kim SH, Nam JS, Yun HJ, Choi JH, Lee EH, Choi IC. Predictive value of rotational thromboelastometry during cardiopulmonary bypass for thrombocytopenia and hypofibrinogenemia after weaning of cardiopulmonary bypass. Korean J Anesthesiol. 2015 Jun;68(3):241-8. doi: 10.4097/kjae.2015.68.3.241. Epub 2015 May 28.
PubMed 26045926Lang T, Johanning K, Metzler H, Piepenbrock S, Solomon C, Rahe-Meyer N, Tanaka KA. The effects of fibrinogen levels on thromboelastometric variables in the presence of thrombocytopenia. Anesth Analg. 2009 Mar;108(3):751-8. doi: 10.1213/ane.0b013e3181966675.
PubMed 19224779Leyra F, Jofre C, Pena N, Olmos E, Del Campo JM, Aranzubia M, Moreno I. Prediction of platelet counts with ROTEM-sigma in cardiac surgery. Minerva Anestesiol. 2022 Jul-Aug;88(7-8):573-579. doi: 10.23736/S0375-9393.22.15912-2. Epub 2022 Apr 5.
PubMed 35381835Solomon C, Collis RE, Collins PW. Haemostatic monitoring during postpartum haemorrhage and implications for management. Br J Anaesth. 2012 Dec;109(6):851-63. doi: 10.1093/bja/aes361. Epub 2012 Oct 16.
PubMed 23075633Bell SF, Collis RE, Bailey C, James K, John M, Kelly K, Kitchen T, Scarr C, Macgillivray E, Collins PW. The incidence, aetiology, and coagulation management of massive postpartum haemorrhage: a two-year national prospective cohort study. Int J Obstet Anesth. 2021 Aug;47:102983. doi: 10.1016/j.ijoa.2021.102983. Epub 2021 Mar 26.
PubMed 33994274Duque González P. Tromboelastometría. Rev Elect AnestesiaR. 2017;9(7):3. Disponible en: http://anestesiar.org/2016/tromboelastometria/
Jones RM, de Lloyd L, Kealaher EJ, Lilley GJ, Precious E, Burckett St Laurent D, Hamlyn V, Collis RE, Collins PW; collaborators. Platelet count and transfusion requirements during moderate or severe postpartum haemorrhage. Anaesthesia. 2016 Jun;71(6):648-56. doi: 10.1111/anae.13448. Epub 2016 Apr 6.
PubMed 27062151Llau JV, Aldecoa C, Guasch E, Marco P, Marcos-Neira P, Paniagua P, et al. Documento multidisciplinar de consenso sobre el manejo de la hemorragia masiva. Primera actualización 2023 (documento HEMOMAS-II). Rev Esp Anestesiol Reanim. 2023;70(7):409-421. doi:10.1016/j.redar.2023.05.001
Park YH. Diagnosis and management of thrombocytopenia in pregnancy. Blood Res. 2022 Apr 30;57(S1):79-85. doi: 10.5045/br.2022.2022068.
PubMed 35483931Reese JA, Peck JD, Deschamps DR, McIntosh JJ, Knudtson EJ, Terrell DR, Vesely SK, George JN. Platelet Counts during Pregnancy. N Engl J Med. 2018 Jul 5;379(1):32-43. doi: 10.1056/NEJMoa1802897.
PubMed 29972751Liew-Spilger AE, Sorg NR, Brenner TJ, Langford JH, Berquist M, Mark NM, Moore SH, Mark J, Baumgartner S, Abernathy MP. Viscoelastic Hemostatic Assays for Postpartum Hemorrhage. J Clin Med. 2021 Aug 31;10(17):3946. doi: 10.3390/jcm10173946.
PubMed 34501395Sociedad Española de Trombosis y Hemostasia (SETH). Guía multidisciplinar para el manejo de la hemorragia posparto [Internet]. Madrid: SETH; 2024 [citado 2025 dic 27]. Disponible en: https://seth.es/formacion/guia-multidisciplinar-para-el-manejo-de-la-hemorragia-posparto
Sociedad Española de Anestesiología, Reanimación y Terapéutica del Dolor (SEDAR). Protocolos asistenciales de anestesia obstétrica [Internet]. 3.ª ed. Madrid: SEDAR; 2022 [citado 2025 dic 27]. Disponible en: https://www.sedar.es/images/images/site/SECCIONES/obstetricia/Protocolos_Asistenciales_Anestesia_Obstetrica_SEDAR_3_Edicion.pdf
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Platelet Function Using Viscoelastic Test (ROTEM® Sigma) in Obstetric Anesthesia: an Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07616349
- Acronym / sponsor ID
- ROTEMPLAQ
- Conditions
- Thrombocytopenia, Postpartum Haemorrhage (PPH)
- Keywords
- Platelet function, viscoelastic test, Obstetric hemostasis, thrombocytopenia, postpartum haemorrhage, PPH, ROTEM
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Nicolas BroglyUniversity, hospital or other
- Study start
- 1 May 2026 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 1 Jun 2026 (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.
This prospective observational, non-interventional, single-center study aims to evaluate whether the viscoelastic parameter PLTEM, derived from ROTEM® sigma testing (EXTEM-A5 minus FIBTEM-A5), can accurately estimate platelet count in obstetric patients with thrombocytopenia and/or severe postpartum hemorrhage.
The study will include pregnant women older than 18 years managed during labor and delivery at the Hospital General Universitario Gregorio Marañón, Madrid (Spain).
The primary objective is to validate the clinical usefulness of PLTEM as a rapid point-of-care tool to support clinical decision-making regarding neuraxial anesthesia and transfusion management in obstetric emergencies.
Detailed description
Obstetric hemorrhage remains the leading cause of maternal mortality worldwide. In Spain, recent studies estimate an incidence between 2% and 5%. The main causes include uterine atony, genital tract trauma, retained placental tissue, and coagulation disorders. Early recognition and management of coagulation abnormalities are essential to reduce maternal morbidity and mortality.
Viscoelastic testing using rotational thromboelastometry (ROTEM® sigma) provides dynamic real-time assessment of coagulation and has become increasingly integrated into obstetric hemorrhage management algorithms. Platelet function plays a major role in clot formation, and impairment of platelet quantity or function may influence transfusion strategies and the safety of neuraxial anesthesia techniques.
The PLTEM parameter (Platelet contribution to clot firmness) estimates platelet contribution to clot strength and is calculated as the difference between EXTEM-A5 and FIBTEM-A5. In other clinical settings, PLTEM-derived measurements have demonstrated the ability to estimate platelet count with good accuracy. However, evidence validating its utility in obstetric patients remains limited.
The hypothesis of this study is that PLTEM may provide a reliable and rapid estimation of platelet count in urgent obstetric settings, thereby optimizing clinical decision-making, facilitating safer neuraxial anesthesia management, and improving transfusion practices.
This is a prospective, observational, non-interventional, single-center study conducted at the Hospital General Universitario Gregorio Marañón, Madrid (Spain). The study population will include pregnant women older than 18 years attended during labor and delivery who present with thrombocytopenia of any etiology and/or develop postpartum hemorrhage greater than 1,500 mL. Patients who decline participation will be excluded.
Clinical and laboratory data will be collected as part of routine care during the intrapartum and immediate postpartum periods. Variables recorded will include demographic characteristics, conventional laboratory parameters, ROTEM® variables, neuraxial anesthesia procedures, quantification of hemorrhage, transfusion requirements, need for reintervention, and maternal complications.
The primary objective is to validate the clinical usefulness of PLTEM in the obstetric setting and assess its correlation with conventional platelet count measurements. Secondary objectives include evaluation of additional ROTEM® parameters associated with coagulation abnormalities, assessment of transfusion requirements and hemorrhagic outcomes, and exploration of the relationship between thrombocytopenia, fibrinogen levels, and other factors contributing to obstetric coagulopathy.
The estimated minimum sample size is 85 patients, adjusted for an anticipated 20% loss rate. Statistical analyses will be performed using SPSS version 29.0. The study period will extend from protocol approval until completion of recruitment, with an anticipated completion date of December 2026.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Obstetric Patients with confirmed or suspicion of thrombocytopenia | – | Other: No Intervention: Observational CohortThe study will include all the consecutive consenting parturients admitted to our maternal unit in the inclusion period with the following inclusion and exclusion criteria. Inclusion criteria: Parturients with a suspicion or confirmed thrombocytopenia before delivery (platelet count < 120x10^9/L), Parturients with severe postpartum haemorrhage (blood loss >1500 mL) with a suspicion of thrombocytopenia. Exclusion criteria: parturient age under 18 years; refusal to participate |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cohort of consecutive consenting patients with suspicion and/or confirmed thrombocytopenia admitted in the labor ward, the obstetric operating room or the obstetric post anaesthetic care unit for delivery in a tertiary university hospital in Madrid-Spain for a period of 1 year.
Key inclusion criteria (2 listed)
- Parturients with a suspicion or confirmed thrombocytopenia before delivery (platelet count < 120x10^9/L),
- Parturients with severe postpartum haemorrhage (blood loss >1500 mL) with a suspicion of thrombocytopenia.
Key exclusion criteria (2 listed)
- parturient age under 18 years;
- refusal to participate
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 |
|---|---|---|
| No Intervention: Observational CohortNo intervention: observational study | Other | Obstetric Patients with confirmed or suspicion of thrombocytopenia |
Primary outcome
To evaluate the correlation between PLTEM value and platelet count on hemogram
Time frame: At admission to the labour ward in case of thrombocytopenia inferior to 120,000 /mm^3 platelets in the third trimester of pregnancy, or at diagnosis of a severe Post-Partum Hemorrhage > 1,500 mL, until 24 hours after delivery or cesarean delivery.
A blood sample will be extracted in patients at risk or with confirmed thrombcytopenia. A simultaneous platelet count (standard biological test) and ROTEM sigma viscoelastic test will be performed. The correlation between PLTEM5 (EXTEM A5 - FIBTEM A5), PLTEM10 (EXTEM A10 - FIBTEM A10) and platelet count will be determined.
2 secondary outcomes
Relationship between ROTEM® parameters, thrombocytopenia, and fibrinogen levels
Time frame: From admission to the labour ward or from diagnosis of severe postpartum hemorrhage (>1,500 mL), through 24 hours postpartum.
PLTEM threshold for safe neuraxial anesthesia in thrombocytopenic obstetric patients
Time frame: At admission to the labour ward.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Background: PubMed 32273281Bell SF, Kitchen T, John M, Scarr C, Kelly K, Bailey C, James K, Watkins A, Macgillivray E, Edey T, Greaves K, Volikas I, Tozer J, Sengupta N, Francis C, Collis R, Collins P. Designing and implementing an all Wales postpartum haemorrhage quality improvement project: OBS Cymru (the Obstetric Bleeding Strategy for Wales). BMJ Open Qual. 2020 Apr;9(2):e000854. doi: 10.1136/bmjoq-2019-000854.
- Background: PubMed 31699598Scala E, Coutaz C, Gomez F, Alberio L, Marcucci C. Comparison of ROTEM Sigma to Standard Laboratory Tests and Development of an Algorithm for the Management of Coagulopathic Bleeding in a Tertiary Center. J Cardiothorac Vasc Anesth. 2020 Mar;34(3):640-649. doi: 10.1053/j.jvca.2019.10.016. Epub 2019 Oct 11.
- Background: PubMed 26045926Ji SM, Kim SH, Nam JS, Yun HJ, Choi JH, Lee EH, Choi IC. Predictive value of rotational thromboelastometry during cardiopulmonary bypass for thrombocytopenia and hypofibrinogenemia after weaning of cardiopulmonary bypass. Korean J Anesthesiol. 2015 Jun;68(3):241-8. doi: 10.4097/kjae.2015.68.3.241. Epub 2015 May 28.
- Background: PubMed 19224779Lang T, Johanning K, Metzler H, Piepenbrock S, Solomon C, Rahe-Meyer N, Tanaka KA. The effects of fibrinogen levels on thromboelastometric variables in the presence of thrombocytopenia. Anesth Analg. 2009 Mar;108(3):751-8. doi: 10.1213/ane.0b013e3181966675.
- Background: PubMed 35381835Leyra F, Jofre C, Pena N, Olmos E, Del Campo JM, Aranzubia M, Moreno I. Prediction of platelet counts with ROTEM-sigma in cardiac surgery. Minerva Anestesiol. 2022 Jul-Aug;88(7-8):573-579. doi: 10.23736/S0375-9393.22.15912-2. Epub 2022 Apr 5.
- Background: PubMed 23075633Solomon C, Collis RE, Collins PW. Haemostatic monitoring during postpartum haemorrhage and implications for management. Br J Anaesth. 2012 Dec;109(6):851-63. doi: 10.1093/bja/aes361. Epub 2012 Oct 16.
- Background: PubMed 33994274Bell SF, Collis RE, Bailey C, James K, John M, Kelly K, Kitchen T, Scarr C, Macgillivray E, Collins PW. The incidence, aetiology, and coagulation management of massive postpartum haemorrhage: a two-year national prospective cohort study. Int J Obstet Anesth. 2021 Aug;47:102983. doi: 10.1016/j.ijoa.2021.102983. Epub 2021 Mar 26.
- BackgroundDuque González P. Tromboelastometría. Rev Elect AnestesiaR. 2017;9(7):3. Disponible en: http://anestesiar.org/2016/tromboelastometria/
- Background: PubMed 27062151Jones RM, de Lloyd L, Kealaher EJ, Lilley GJ, Precious E, Burckett St Laurent D, Hamlyn V, Collis RE, Collins PW; collaborators. Platelet count and transfusion requirements during moderate or severe postpartum haemorrhage. Anaesthesia. 2016 Jun;71(6):648-56. doi: 10.1111/anae.13448. Epub 2016 Apr 6.
- BackgroundLlau JV, Aldecoa C, Guasch E, Marco P, Marcos-Neira P, Paniagua P, et al. Documento multidisciplinar de consenso sobre el manejo de la hemorragia masiva. Primera actualización 2023 (documento HEMOMAS-II). Rev Esp Anestesiol Reanim. 2023;70(7):409-421. doi:10.1016/j.redar.2023.05.001
- Background: PubMed 35483931Park YH. Diagnosis and management of thrombocytopenia in pregnancy. Blood Res. 2022 Apr 30;57(S1):79-85. doi: 10.5045/br.2022.2022068.
- Background: PubMed 29972751Reese JA, Peck JD, Deschamps DR, McIntosh JJ, Knudtson EJ, Terrell DR, Vesely SK, George JN. Platelet Counts during Pregnancy. N Engl J Med. 2018 Jul 5;379(1):32-43. doi: 10.1056/NEJMoa1802897.
- Individual participant dataSharing planned: No. This was not considered in the design of the research.
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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.
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 Thrombocytopenia and Postpartum Haemorrhage (PPH), run by Nicolas Brogly at 1 site in Spain.
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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 1 Jun 2026. 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 Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicolas Brogly, MD, PhD (+34 663676820, nicolas.brogly@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the correlation between PLTEM value and platelet count on hemogram (time frame: At admission to the labour ward in case of thrombocytopenia inferior to 120,000 /mm^3 platelets in the third trimester of pregnancy, or at diagnosis of a severe Post-Partum Hemorrhage > 1,500 mL, until 24 hours after delivery or cesarean 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 NCT07616349, which also lists 21 linked publications.
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 1 Jun 2026.