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

Sponsor
Nicolas Brogly
Study ID
NCT07616349
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • No Intervention: Observational Cohort — OTHER
    No intervention: observational study

Study Details

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.

Key Dates

Start date
May 1, 2026
Status verified
May 2026
Primary completion
May 1, 2027
Completion
May 1, 2027

Study Design

Enrollment
85 participants (estimated)

Arms

  • Arm: 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

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. ]

Central Contacts

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