Prediction of Platelet Function Using Viscoelastic Test (ROTEM® Sigma) in Obstetric Anesthesia.
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Nicolas Brogly, MD, PhD
- 電話番号：+34 663676820
- メール：nicolas.brogly@salud.madrid.org
研究連絡先のバックアップ
- 名前：Aránzazu Rodríguez Catalán, MD
- 電話番号：+34 627476391
- メール：arodriguezc293dd6@salud.madrid.org
研究場所
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Madrid、スペイン、28007
- 募集
- Hospital General Universitario Gregorio Marañon
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コンタクト：
- Aránzazu Rodríguez Catalán, MD
- 電話番号：+34 627476391
- メール：arodriguezc293dd6@salud.madrid.org
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
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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 |
介入なし：観察研究
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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To evaluate the correlation between PLTEM value and platelet count on hemogram
時間枠：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.
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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.
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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.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Relationship between ROTEM® parameters, thrombocytopenia, and fibrinogen levels
時間枠：From admission to the labour ward or from diagnosis of severe postpartum hemorrhage (>1,500 mL), through 24 hours postpartum.
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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.
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From admission to the labour ward or from diagnosis of severe postpartum hemorrhage (>1,500 mL), through 24 hours postpartum.
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PLTEM threshold for safe neuraxial anesthesia in thrombocytopenic obstetric patients
時間枠：At admission to the labour ward.
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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.
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At admission to the labour ward.
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協力者と研究者
スポンサー
出版物と役立つリンク
一般刊行物
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Duque 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.
- 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
- Park YH. Diagnosis and management of thrombocytopenia in pregnancy. Blood Res. 2022 Apr 30;57(S1):79-85. doi: 10.5045/br.2022.2022068.
- 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.
- 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
- 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
- Morillas Ramírez F, Pintado Recarte P, et al. Protocolo de hemorragia obstétrica severa (PHOS). Versión 3. Madrid: Hospital General Universitario Gregorio Marañón; 2016.
- 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.
- 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.
- 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.
- 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.
- 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.
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- ROTEMPLAQ
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