Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

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

29 maj 2026 uppdaterad av: Nicolas Brogly

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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Beräknad)

85

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

  • Spanien
      • Madrid, Spanien, 28007
        • Rekrytering
        • Hospital General Universitario Gregorio Marañón
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Testmetod

Sannolikhetsprov

Studera befolkning

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.

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
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
Övrig: Ingen intervention: Observationskohort
Ingen intervention: observationsstudie

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
To evaluate the correlation between PLTEM value and platelet count on hemogram
Tidsram: 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.
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.

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Relationship between ROTEM® parameters, thrombocytopenia, and fibrinogen levels
Tidsram: From admission to the labour ward or from diagnosis of severe postpartum hemorrhage (>1,500 mL), through 24 hours postpartum.
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.
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
Tidsram: At admission to the labour ward.
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.
At admission to the labour ward.

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Nicolas Brogly

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 maj 2026

Primärt slutförande (Beräknad)

1 maj 2027

Avslutad studie (Beräknad)

1 maj 2027

Studieregistreringsdatum

Först inskickad

28 april 2026

Först inskickad som uppfyllde QC-kriterierna

29 maj 2026

Första postat (Faktisk)

1 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

1 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

29 maj 2026

Senast verifierad

1 maj 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • ROTEMPLAQ

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

This was not considered in the design of the research.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera