Prediction of Platelet Function Using Viscoelastic Test (ROTEM® Sigma) in Obstetric Anesthesia.

NCT07616349 | Recruiting

• 1 other identifier: ROTEMPLAQ
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Thrombocytopenia; Postpartum Haemorrhage (PPH)

Keywords

Platelet function; viscoelastic test; Obstetric hemostasis; thrombocytopenia; postpartum haemorrhage; PPH; ROTEM

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  At admission to the labour ward.

Study Arms (1)

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

Other: No Intervention: Observational Cohort

Interventions

No Intervention: Observational Cohort OTHER

No intervention: observational study

Obstetric Patients with confirmed or suspicion of thrombocytopenia

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• parturient age under 18 years;
• refusal to participate

Sponsors & Collaborators

• Nicolas Brogly: lead

Study Sites (1)

Hospital General Universitario Gregorio Marañón

Madrid, 28007, Spain

RECRUITING

Related Publications (21)

• 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.

  PMID: 32273281 BACKGROUND

• Scala 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.

  PMID: 31699598 BACKGROUND

• Ji 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.

  PMID: 26045926 BACKGROUND

• Lang 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.

  PMID: 19224779 BACKGROUND

• Leyra 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.

  PMID: 35381835 BACKGROUND

• Solomon 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.

  PMID: 23075633 BACKGROUND

• Bell 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.

  PMID: 33994274 BACKGROUND

• Duque González P. Tromboelastometría. Rev Elect AnestesiaR. 2017;9(7):3. Disponible en: http://anestesiar.org/2016/tromboelastometria/

  BACKGROUND

• 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.

  PMID: 27062151 BACKGROUND

• Llau 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

• Park YH. Diagnosis and management of thrombocytopenia in pregnancy. Blood Res. 2022 Apr 30;57(S1):79-85. doi: 10.5045/br.2022.2022068.

  PMID: 35483931 BACKGROUND

• Reese 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.

  PMID: 29972751 BACKGROUND

• Liew-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.

  PMID: 34501395 BACKGROUND

• Sociedad 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

  BACKGROUND

• 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

  BACKGROUND

• Morillas Ramírez F, Pintado Recarte P, et al. Protocolo de hemorragia obstétrica severa (PHOS). Versión 3. Madrid: Hospital General Universitario Gregorio Marañón; 2016.

  BACKGROUND

• World Health Organization. Hoja de ruta para combatir la hemorragia puerperal entre el anuncio del embarazo y hasta 24 horas después del parto. Ginebra: Organización Mundial de la Salud; 2024.

  BACKGROUND

• Data not yet published: Organon/Savana. SAPPHIRE-O study: incidence of postpartum hemorrhage in Spain using artificial intelligence analysis of real-world data. Presented at: Sociedad Española de Medicina Perinatal (SEMEPE); 2024.

  BACKGROUND

• Puertas A, et al; Grupo Español de Seguridad Obstétrica. Registro español de morbimortalidad materna y perinatal. Datos año 2021. Madrid: Grupo Español de Seguridad Obstétrica; 2022.

  BACKGROUND

• Aceto P, Punzo G, Di Franco V, Teofili L, Gaspari R, Avolio AW, Del Tedesco F, Posa D, Lai C, Sollazzi L. Viscoelastic versus conventional coagulation tests to reduce blood product transfusion in patients undergoing liver transplantation: A systematic review and meta-analysis. Eur J Anaesthesiol. 2023 Jan 1;40(1):39-53. doi: 10.1097/EJA.0000000000001780. Epub 2022 Nov 22.

  PMID: 36412263 BACKGROUND

• de Lloyd L, Jenkins PV, Bell SF, Mutch NJ, Martins Pereira JF, Badenes PM, James D, Ridgeway A, Cohen L, Roberts T, Field V, Collis RE, Collins PW. Acute obstetric coagulopathy during postpartum hemorrhage is caused by hyperfibrinolysis and dysfibrinogenemia: an observational cohort study. J Thromb Haemost. 2023 Apr;21(4):862-879. doi: 10.1016/j.jtha.2022.11.036. Epub 2022 Dec 22.

  PMID: 36696216 BACKGROUND

MeSH Terms

Conditions

Thrombocytopenia; Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Nicolas Brogly, MD, PhD

CONTACT

+34 663676820; nicolas.brogly@salud.madrid.org

Aránzazu Rodríguez Catalán, MD

CONTACT

+34 627476391; arodriguezc293dd6@salud.madrid.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Coordinator of ROTEMPLAQ project

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: June 1, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: June 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)